ClinicalTrials.gov
History of Changes for Study: NCT00066690
Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer (SOFT)
Latest version (submitted December 14, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 23, 2005 None (earliest Version on record)
2 July 8, 2005 Study Status
3 August 2, 2005 Contacts/Locations and Study Status
4 August 16, 2005 Contacts/Locations, Study Status and Study Identification
5 August 22, 2005 Contacts/Locations and Study Status
6 August 29, 2005 Contacts/Locations and Study Status
7 September 6, 2005 Contacts/Locations and Study Status
8 September 8, 2005 Study Status
9 September 15, 2005 Contacts/Locations and Study Status
10 September 20, 2005 Contacts/Locations and Study Status
11 September 26, 2005 Contacts/Locations and Study Status
12 October 12, 2005 Contacts/Locations and Study Status
13 October 20, 2005 Contacts/Locations and Study Status
14 October 25, 2005 Contacts/Locations, Arms and Interventions and Study Status
15 November 3, 2005 Contacts/Locations, Conditions and Study Status
16 November 11, 2005 Contacts/Locations and Study Status
17 November 18, 2005 Contacts/Locations and Study Status
18 November 22, 2005 Contacts/Locations and Study Status
19 December 6, 2005 Contacts/Locations and Study Status
20 December 7, 2005 Contacts/Locations and Study Status
21 December 14, 2005 Contacts/Locations and Study Status
22 December 20, 2005 Contacts/Locations and Study Status
23 January 10, 2006 Contacts/Locations and Study Status
24 January 12, 2006 Contacts/Locations and Study Status
25 January 16, 2006 Contacts/Locations and Study Status
26 January 24, 2006 Contacts/Locations and Study Status
27 February 6, 2006 Contacts/Locations and Study Status
28 February 9, 2006 Contacts/Locations and Study Status
29 March 8, 2006 Contacts/Locations and Study Status
30 March 9, 2006 Contacts/Locations and Study Status
31 March 15, 2006 Contacts/Locations and Study Status
32 March 21, 2006 Contacts/Locations and Study Status
33 March 29, 2006 Contacts/Locations and Study Status
34 April 11, 2006 Contacts/Locations, Study Status, Eligibility, Study Description and Study Identification
35 April 19, 2006 Contacts/Locations and Study Status
36 April 24, 2006 Contacts/Locations, Arms and Interventions and Study Status
37 May 2, 2006 Contacts/Locations and Study Status
38 May 10, 2006 Contacts/Locations and Study Status
39 May 16, 2006 Contacts/Locations and Study Status
40 May 30, 2006 Contacts/Locations and Study Status
41 June 8, 2006 Contacts/Locations and Study Status
42 June 13, 2006 Contacts/Locations and Study Status
43 June 22, 2006 Contacts/Locations and Study Status
44 June 28, 2006 Contacts/Locations and Study Status
45 July 5, 2006 Contacts/Locations and Study Status
46 July 13, 2006 Contacts/Locations and Study Status
47 July 19, 2006 Contacts/Locations and Study Status
48 July 26, 2006 Contacts/Locations and Study Status
49 August 3, 2006 Contacts/Locations and Study Status
50 August 10, 2006 Contacts/Locations and Study Status
51 August 16, 2006 Contacts/Locations and Study Status
52 August 24, 2006 Contacts/Locations and Study Status
53 August 29, 2006 Contacts/Locations and Study Status
54 September 13, 2006 Contacts/Locations and Study Status
55 September 19, 2006 Contacts/Locations and Study Status
56 September 26, 2006 Contacts/Locations and Study Status
57 October 12, 2006 Contacts/Locations, Study Status and Eligibility
58 October 18, 2006 Contacts/Locations and Study Status
59 October 25, 2006 Contacts/Locations, Eligibility and Study Status
60 November 8, 2006 Study Design, Conditions, Study Status, References, Outcome Measures, Study Description and Study Identification
61 November 9, 2006 Contacts/Locations and Study Status
62 November 16, 2006 Contacts/Locations and Study Status
63 November 21, 2006 Contacts/Locations and Study Status
64 November 27, 2006 Contacts/Locations and Study Status
65 December 6, 2006 Contacts/Locations and Study Status
66 December 11, 2006 Contacts/Locations and Study Status
67 December 20, 2006 Contacts/Locations and Study Status
68 December 27, 2006 Contacts/Locations and Study Status
69 January 11, 2007 Study Status
70 January 16, 2007 Study Status and Contacts/Locations
71 January 19, 2007 Contacts/Locations and Study Status
72 January 25, 2007 Contacts/Locations, Eligibility, Study Description and Study Status
73 January 30, 2007 Contacts/Locations and Study Status
74 February 8, 2007 Contacts/Locations and Study Status
75 February 20, 2007 Contacts/Locations, Eligibility and Study Status
76 March 5, 2007 Contacts/Locations and Study Status
77 March 7, 2007 Contacts/Locations and Study Status
78 March 13, 2007 Contacts/Locations and Study Status
79 March 20, 2007 Contacts/Locations and Study Status
80 March 27, 2007 Contacts/Locations and Study Status
81 April 9, 2007 Contacts/Locations and Study Status
82 April 11, 2007 Contacts/Locations and Study Status
83 April 18, 2007 Contacts/Locations and Study Status
84 April 25, 2007 Contacts/Locations and Study Status
85 May 2, 2007 Contacts/Locations and Study Status
86 May 3, 2007 Contacts/Locations and Study Status
87 May 8, 2007 Contacts/Locations and Study Status
88 May 16, 2007 Contacts/Locations and Study Status
89 May 23, 2007 Contacts/Locations and Study Status
90 June 4, 2007 Contacts/Locations and Study Status
91 June 6, 2007 Contacts/Locations and Study Status
92 June 13, 2007 Contacts/Locations and Study Status
93 June 20, 2007 Contacts/Locations and Study Status
94 June 25, 2007 Contacts/Locations and Study Status
95 July 10, 2007 Contacts/Locations, Study Status, Arms and Interventions and Study Identification
96 July 17, 2007 Contacts/Locations and Study Status
97 July 30, 2007 Contacts/Locations and Study Status
98 August 8, 2007 Contacts/Locations and Study Status
99 August 14, 2007 Contacts/Locations and Study Status
100 August 21, 2007 Contacts/Locations and Study Status
101 August 24, 2007 Contacts/Locations and Study Status
102 August 28, 2007 Contacts/Locations and Study Status
103 August 31, 2007 Contacts/Locations and Study Status
104 September 5, 2007 Contacts/Locations and Study Status
105 September 10, 2007 Contacts/Locations and Study Status
106 September 13, 2007 Contacts/Locations and Study Status
107 September 18, 2007 Contacts/Locations and Study Status
108 September 20, 2007 Contacts/Locations and Study Status
109 September 25, 2007 Contacts/Locations and Study Status
110 September 27, 2007 Contacts/Locations and Study Status
111 October 1, 2007 Contacts/Locations and Study Status
112 October 5, 2007 Contacts/Locations and Study Status
113 October 13, 2007 Contacts/Locations and Study Status
114 October 17, 2007 Contacts/Locations and Study Status
115 October 19, 2007 Contacts/Locations and Study Status
116 October 25, 2007 Contacts/Locations, Eligibility, Arms and Interventions and Study Status
117 October 30, 2007 Contacts/Locations and Study Status
118 November 2, 2007 Contacts/Locations and Study Status
119 November 6, 2007 Contacts/Locations and Study Status
120 November 9, 2007 Contacts/Locations and Study Status
121 November 14, 2007 Contacts/Locations and Study Status
122 November 15, 2007 Contacts/Locations and Study Status
123 November 16, 2007 Contacts/Locations and Study Status
124 November 17, 2007 Contacts/Locations and Study Status
125 November 21, 2007 Contacts/Locations and Study Status
126 November 24, 2007 Contacts/Locations and Study Status
127 November 27, 2007 Contacts/Locations and Study Status
128 November 28, 2007 Contacts/Locations and Study Status
129 December 1, 2007 Contacts/Locations and Study Status
130 December 4, 2007 Study Status and Contacts/Locations
131 December 5, 2007 Contacts/Locations and Study Status
132 December 6, 2007 Contacts/Locations, Study Status and Study Identification
133 December 7, 2007 Contacts/Locations and Study Status
134 December 8, 2007 Contacts/Locations and Study Status
135 December 11, 2007 Contacts/Locations and Study Status
136 December 12, 2007 Contacts/Locations and Study Status
137 December 13, 2007 Contacts/Locations and Study Status
138 December 15, 2007 Contacts/Locations, Arms and Interventions and Study Status
139 December 19, 2007 Contacts/Locations and Study Status
140 December 20, 2007 Contacts/Locations and Study Status
141 December 25, 2007 Contacts/Locations and Study Status
142 December 29, 2007 Contacts/Locations and Study Status
143 January 4, 2008 Contacts/Locations and Study Status
144 January 8, 2008 Study Status and Contacts/Locations
145 January 11, 2008 Contacts/Locations and Study Status
146 January 12, 2008 Contacts/Locations and Study Status
147 January 15, 2008 Contacts/Locations and Study Status
148 January 18, 2008 Contacts/Locations and Study Status
149 January 19, 2008 Contacts/Locations and Study Status
150 January 22, 2008 Contacts/Locations and Study Status
151 January 26, 2008 Contacts/Locations and Study Status
152 January 30, 2008 Contacts/Locations and Study Status
153 January 31, 2008 Contacts/Locations and Study Status
154 February 2, 2008 Contacts/Locations and Study Status
155 February 5, 2008 Contacts/Locations and Study Status
156 February 6, 2008 Contacts/Locations and Study Status
157 February 9, 2008 Contacts/Locations and Study Status
158 February 14, 2008 Contacts/Locations and Study Status
159 February 15, 2008 Contacts/Locations and Study Status
160 February 19, 2008 Contacts/Locations and Study Status
161 February 20, 2008 Contacts/Locations and Study Status
162 February 21, 2008 Contacts/Locations and Study Status
163 February 22, 2008 Contacts/Locations and Study Status
164 February 27, 2008 Contacts/Locations and Study Status
165 February 28, 2008 Contacts/Locations and Study Status
166 February 29, 2008 Contacts/Locations and Study Status
167 March 1, 2008 Contacts/Locations and Study Status
168 March 4, 2008 Study Status and Contacts/Locations
169 March 5, 2008 Contacts/Locations and Study Status
170 March 7, 2008 Contacts/Locations and Study Status
171 March 8, 2008 Contacts/Locations and Study Status
172 March 11, 2008 Contacts/Locations and Study Status
173 March 12, 2008 Contacts/Locations and Study Status
174 March 14, 2008 Contacts/Locations and Study Status
175 March 17, 2008 Contacts/Locations and Study Status
176 March 18, 2008 Contacts/Locations and Study Status
177 March 19, 2008 Contacts/Locations and Study Status
178 March 20, 2008 Contacts/Locations and Study Status
179 March 21, 2008 Contacts/Locations and Study Status
180 March 22, 2008 Contacts/Locations and Study Status
181 March 25, 2008 Contacts/Locations and Study Status
182 March 28, 2008 Contacts/Locations and Study Status
183 March 29, 2008 Contacts/Locations and Study Status
184 April 1, 2008 Contacts/Locations and Study Status
185 April 2, 2008 Contacts/Locations and Study Status
186 April 4, 2008 Contacts/Locations and Study Status
187 April 8, 2008 Contacts/Locations and Study Status
188 April 9, 2008 Contacts/Locations and Study Status
189 April 10, 2008 Contacts/Locations and Study Status
190 April 11, 2008 Contacts/Locations and Study Status
191 April 12, 2008 Study Status and Study Identification
192 April 15, 2008 Contacts/Locations and Study Status
193 April 17, 2008 Contacts/Locations and Study Status
194 April 18, 2008 Contacts/Locations and Study Status
195 April 19, 2008 Contacts/Locations and Study Status
196 April 22, 2008 Contacts/Locations and Study Status
197 April 24, 2008 Contacts/Locations and Study Status
198 April 25, 2008 Contacts/Locations and Study Status
199 April 26, 2008 Contacts/Locations and Study Status
200 April 29, 2008 Contacts/Locations and Study Status
201 May 6, 2008 Study Status and Contacts/Locations
202 May 8, 2008 Contacts/Locations and Study Status
203 May 9, 2008 Contacts/Locations and Study Status
204 May 11, 2008 Contacts/Locations and Study Status
205 May 13, 2008 Contacts/Locations and Study Status
206 May 16, 2008 Contacts/Locations and Study Status
207 May 20, 2008 Contacts/Locations and Study Status
208 May 22, 2008 Contacts/Locations and Study Status
209 May 24, 2008 Contacts/Locations, Arms and Interventions and Study Status
210 May 27, 2008 Contacts/Locations and Study Status
211 May 29, 2008 Contacts/Locations and Study Status
212 May 31, 2008 Contacts/Locations and Study Status
213 June 3, 2008 Contacts/Locations and Study Status
214 June 4, 2008 Study Status and Contacts/Locations
215 June 6, 2008 Contacts/Locations and Study Status
216 June 7, 2008 Contacts/Locations and Study Status
217 June 10, 2008 Contacts/Locations and Study Status
218 June 11, 2008 Contacts/Locations and Study Status
219 June 12, 2008 Contacts/Locations and Study Status
220 June 17, 2008 Contacts/Locations and Study Status
221 June 18, 2008 Contacts/Locations and Study Status
222 June 20, 2008 Contacts/Locations and Study Status
223 June 21, 2008 Contacts/Locations and Study Status
224 June 24, 2008 Contacts/Locations and Study Status
225 June 26, 2008 Contacts/Locations and Study Status
226 June 27, 2008 Contacts/Locations and Study Status
227 June 28, 2008 Contacts/Locations and Study Status
228 July 1, 2008 Contacts/Locations and Study Status
229 July 2, 2008 Study Status and Contacts/Locations
230 July 3, 2008 Contacts/Locations and Study Status
231 July 8, 2008 Contacts/Locations and Study Status
232 July 9, 2008 Contacts/Locations and Study Status
233 July 10, 2008 Contacts/Locations and Study Status
234 July 11, 2008 Contacts/Locations and Study Status
235 July 12, 2008 Contacts/Locations and Study Status
236 July 15, 2008 Contacts/Locations and Study Status
237 July 16, 2008 Contacts/Locations and Study Status
238 July 17, 2008 Contacts/Locations and Study Status
239 July 18, 2008 Contacts/Locations and Study Status
240 July 22, 2008 Contacts/Locations and Study Status
241 July 23, 2008 Contacts/Locations, Study Design and Study Status
242 July 24, 2008 Contacts/Locations and Study Status
243 July 25, 2008 Contacts/Locations and Study Status
244 July 26, 2008 Contacts/Locations and Study Status
245 July 29, 2008 Contacts/Locations and Study Status
246 July 31, 2008 Contacts/Locations and Study Status
247 August 1, 2008 Contacts/Locations and Study Status
248 August 2, 2008 Contacts/Locations and Study Status
249 August 6, 2008 Contacts/Locations and Study Status
250 August 8, 2008 Contacts/Locations and Study Status
251 August 12, 2008 Contacts/Locations and Study Status
252 August 14, 2008 Contacts/Locations and Study Status
253 August 15, 2008 Contacts/Locations and Study Status
254 August 19, 2008 Contacts/Locations and Study Status
255 August 20, 2008 Contacts/Locations and Study Status
256 August 21, 2008 Contacts/Locations and Study Status
257 August 22, 2008 Contacts/Locations and Study Status
258 August 23, 2008 Contacts/Locations and Study Status
259 August 26, 2008 Contacts/Locations and Study Status
260 August 27, 2008 Contacts/Locations and Study Status
261 August 28, 2008 Contacts/Locations and Study Status
262 August 29, 2008 Contacts/Locations and Study Status
263 September 2, 2008 Contacts/Locations and Study Status
264 September 5, 2008 Contacts/Locations and Study Status
265 September 6, 2008 Contacts/Locations and Study Status
266 September 9, 2008 Contacts/Locations and Study Status
267 September 10, 2008 Contacts/Locations and Study Status
268 September 11, 2008 Contacts/Locations and Study Status
269 September 13, 2008 Contacts/Locations and Study Status
270 September 17, 2008 Contacts/Locations and Study Status
271 September 18, 2008 Contacts/Locations and Study Status
272 September 22, 2008 Contacts/Locations and Study Status
273 October 1, 2008 Contacts/Locations and Study Status
274 October 2, 2008 Study Status
275 October 3, 2008 Contacts/Locations and Study Status
276 October 4, 2008 Contacts/Locations and Study Status
277 October 8, 2008 Contacts/Locations and Study Status
278 October 9, 2008 Contacts/Locations and Study Status
279 October 10, 2008 Contacts/Locations and Study Status
280 October 14, 2008 Contacts/Locations and Study Status
281 October 15, 2008 Contacts/Locations and Study Status
282 October 16, 2008 Contacts/Locations and Study Status
283 October 17, 2008 Contacts/Locations and Study Status
284 October 18, 2008 Contacts/Locations and Study Status
285 October 21, 2008 Contacts/Locations and Study Status
286 October 22, 2008 Study Status
287 October 23, 2008 Contacts/Locations and Study Status
288 October 24, 2008 Contacts/Locations and Study Status
289 October 25, 2008 Contacts/Locations and Study Status
290 October 28, 2008 Contacts/Locations and Study Status
291 October 29, 2008 Contacts/Locations and Study Status
292 October 31, 2008 Contacts/Locations and Study Status
293 November 1, 2008 Contacts/Locations and Study Status
294 November 4, 2008 Contacts/Locations and Study Status
295 November 5, 2008 Contacts/Locations and Study Status
296 November 7, 2008 Contacts/Locations and Study Status
297 November 8, 2008 Contacts/Locations and Study Status
298 November 12, 2008 Contacts/Locations and Study Status
299 November 14, 2008 Contacts/Locations and Study Status
300 November 16, 2008 Contacts/Locations and Study Status
301 November 18, 2008 Contacts/Locations and Study Status
302 November 19, 2008 Contacts/Locations and Study Status
303 November 20, 2008 Contacts/Locations and Study Status
304 November 21, 2008 Contacts/Locations and Study Status
305 November 22, 2008 Contacts/Locations and Study Status
306 November 25, 2008 Contacts/Locations and Study Status
307 November 28, 2008 Contacts/Locations and Study Status
308 November 29, 2008 Contacts/Locations and Study Status
309 December 2, 2008 Study Status and Contacts/Locations
310 December 3, 2008 Contacts/Locations and Study Status
311 December 4, 2008 Contacts/Locations and Study Status
312 December 5, 2008 Contacts/Locations and Study Status
313 December 9, 2008 Contacts/Locations and Study Status
314 December 10, 2008 Contacts/Locations and Study Status
315 December 12, 2008 Contacts/Locations and Study Status
316 December 13, 2008 Contacts/Locations and Study Status
317 December 16, 2008 Contacts/Locations and Study Status
318 December 18, 2008 Contacts/Locations and Study Status
319 December 19, 2008 Contacts/Locations and Study Status
320 December 23, 2008 Contacts/Locations and Study Status
321 December 24, 2008 Contacts/Locations and Study Status
322 December 26, 2008 Study Status, Contacts/Locations and Study Description
323 January 2, 2009 Study Status and Contacts/Locations
324 January 6, 2009 Contacts/Locations and Study Status
325 January 7, 2009 Contacts/Locations and Study Status
326 January 9, 2009 Contacts/Locations and Study Status
327 January 10, 2009 Contacts/Locations and Study Status
328 January 13, 2009 Contacts/Locations and Study Status
329 January 15, 2009 Contacts/Locations and Study Status
330 January 21, 2009 Contacts/Locations and Study Status
331 January 22, 2009 Contacts/Locations and Study Status
332 January 23, 2009 Contacts/Locations and Study Status
333 January 24, 2009 Contacts/Locations and Study Status
334 January 27, 2009 Contacts/Locations and Study Status
335 January 28, 2009 Contacts/Locations and Study Status
336 January 29, 2009 Contacts/Locations and Study Status
337 January 30, 2009 Contacts/Locations and Study Status
338 February 3, 2009 Contacts/Locations and Study Status
339 February 4, 2009 Contacts/Locations, Arms and Interventions and Study Status
340 February 5, 2009 Contacts/Locations and Study Status
341 February 7, 2009 Contacts/Locations and Study Status
342 February 10, 2009 Contacts/Locations and Study Status
343 February 11, 2009 Contacts/Locations and Study Status
344 February 12, 2009 Contacts/Locations and Study Status
345 February 13, 2009 Contacts/Locations and Study Status
346 February 14, 2009 Contacts/Locations and Study Status
347 February 18, 2009 Contacts/Locations and Study Status
348 February 19, 2009 Contacts/Locations and Study Status
349 February 20, 2009 Contacts/Locations and Study Status
350 February 21, 2009 Contacts/Locations and Study Status
351 February 24, 2009 Contacts/Locations and Study Status
352 February 25, 2009 Contacts/Locations and Study Status
353 February 26, 2009 Contacts/Locations and Study Status
354 February 27, 2009 Contacts/Locations and Study Status
355 February 28, 2009 Contacts/Locations and Study Status
356 March 3, 2009 Contacts/Locations and Study Status
357 March 5, 2009 Contacts/Locations and Study Status
358 March 6, 2009 Contacts/Locations and Study Status
359 March 10, 2009 Contacts/Locations and Study Status
360 March 11, 2009 Contacts/Locations and Study Status
361 March 12, 2009 Contacts/Locations and Study Status
362 March 13, 2009 Contacts/Locations and Study Status
363 March 14, 2009 Contacts/Locations and Study Status
364 March 17, 2009 Contacts/Locations and Study Status
365 March 18, 2009 Contacts/Locations and Study Status
366 March 19, 2009 Contacts/Locations and Study Status
367 March 20, 2009 Contacts/Locations and Study Status
368 March 21, 2009 Contacts/Locations and Study Status
369 March 24, 2009 Contacts/Locations and Study Status
370 March 26, 2009 Contacts/Locations and Study Status
371 March 27, 2009 Contacts/Locations and Study Status
372 March 28, 2009 Contacts/Locations and Study Status
373 March 31, 2009 Contacts/Locations and Study Status
374 April 1, 2009 Contacts/Locations and Study Status
375 April 2, 2009 Study Status and Contacts/Locations
376 April 6, 2009 Contacts/Locations and Study Status
377 April 7, 2009 Arms and Interventions and Study Status
378 April 9, 2009 Contacts/Locations and Study Status
379 April 10, 2009 Contacts/Locations and Study Status
380 April 11, 2009 Contacts/Locations and Study Status
381 April 14, 2009 Contacts/Locations, Sponsor/Collaborators and Study Status
382 April 18, 2009 Contacts/Locations and Study Status
383 April 21, 2009 Contacts/Locations and Study Status
384 April 22, 2009 Contacts/Locations and Study Status
385 April 23, 2009 Contacts/Locations and Study Status
386 April 24, 2009 Contacts/Locations and Study Status
387 April 26, 2009 Contacts/Locations and Study Status
388 April 28, 2009 Contacts/Locations and Study Status
389 April 29, 2009 Contacts/Locations and Study Status
390 April 30, 2009 Contacts/Locations and Study Status
391 May 2, 2009 Study Status and Contacts/Locations
392 May 5, 2009 Contacts/Locations and Study Status
393 May 7, 2009 Contacts/Locations and Study Status
394 May 8, 2009 Contacts/Locations and Study Status
395 May 9, 2009 Contacts/Locations and Study Status
396 May 12, 2009 Contacts/Locations and Study Status
397 May 13, 2009 Contacts/Locations and Study Status
398 May 14, 2009 Contacts/Locations and Study Status
399 May 15, 2009 Contacts/Locations and Study Status
400 May 16, 2009 Contacts/Locations and Study Status
401 May 19, 2009 Contacts/Locations and Study Status
402 May 20, 2009 Contacts/Locations and Study Status
403 May 21, 2009 Contacts/Locations and Study Status
404 May 26, 2009 Contacts/Locations and Study Status
405 May 28, 2009 Contacts/Locations and Study Status
406 May 29, 2009 Contacts/Locations and Study Status
407 May 30, 2009 Contacts/Locations and Study Status
408 June 2, 2009 Contacts/Locations and Study Status
409 June 3, 2009 Study Status and Contacts/Locations
410 June 4, 2009 Contacts/Locations and Study Status
411 June 5, 2009 Contacts/Locations and Study Status
412 June 6, 2009 Contacts/Locations and Study Status
413 June 9, 2009 Contacts/Locations and Study Status
414 June 10, 2009 Contacts/Locations and Study Status
415 June 17, 2009 Contacts/Locations and Study Status
416 June 18, 2009 Contacts/Locations and Study Status
417 June 19, 2009 Contacts/Locations and Study Status
418 June 20, 2009 Contacts/Locations and Study Status
419 June 23, 2009 Contacts/Locations and Study Status
420 June 24, 2009 Contacts/Locations and Study Status
421 June 25, 2009 Contacts/Locations and Study Status
422 June 26, 2009 Contacts/Locations and Study Status
423 June 27, 2009 Contacts/Locations and Study Status
424 July 1, 2009 Contacts/Locations and Study Status
425 July 2, 2009 Contacts/Locations and Study Status
426 July 3, 2009 Contacts/Locations and Study Status
427 July 7, 2009 Contacts/Locations and Study Status
428 July 9, 2009 Contacts/Locations and Study Status
429 July 10, 2009 Contacts/Locations and Study Status
430 July 11, 2009 Contacts/Locations and Study Status
431 July 14, 2009 Contacts/Locations and Study Status
432 July 15, 2009 Contacts/Locations and Study Status
433 July 16, 2009 Contacts/Locations and Study Status
434 July 17, 2009 Contacts/Locations and Study Status
435 July 21, 2009 Contacts/Locations and Study Status
436 July 23, 2009 Contacts/Locations and Study Status
437 July 24, 2009 Contacts/Locations and Study Status
438 July 28, 2009 Contacts/Locations and Study Status
439 July 29, 2009 Contacts/Locations and Study Status
440 August 1, 2009 Contacts/Locations and Study Status
441 August 5, 2009 Contacts/Locations, Sponsor/Collaborators and Study Status
442 August 6, 2009 Contacts/Locations and Study Status
443 August 7, 2009 Contacts/Locations and Study Status
444 August 8, 2009 Contacts/Locations and Study Status
445 August 11, 2009 Contacts/Locations and Study Status
446 August 12, 2009 Contacts/Locations and Study Status
447 August 14, 2009 Contacts/Locations and Study Status
448 August 16, 2009 Contacts/Locations and Study Status
449 August 19, 2009 Contacts/Locations and Study Status
450 August 20, 2009 Contacts/Locations and Study Status
451 August 21, 2009 Contacts/Locations and Study Status
452 August 25, 2009 Contacts/Locations and Study Status
453 August 28, 2009 Contacts/Locations and Study Status
454 August 29, 2009 Contacts/Locations and Study Status
455 September 1, 2009 Contacts/Locations and Study Status
456 September 3, 2009 Study Status and Contacts/Locations
457 September 8, 2009 Contacts/Locations and Study Status
458 September 11, 2009 Contacts/Locations and Study Status
459 September 12, 2009 Contacts/Locations and Study Status
460 September 15, 2009 Contacts/Locations and Study Status
461 September 16, 2009 Contacts/Locations and Study Status
462 September 17, 2009 Contacts/Locations and Study Status
463 September 18, 2009 Contacts/Locations and Study Status
464 September 22, 2009 Contacts/Locations and Study Status
465 September 23, 2009 Contacts/Locations and Study Status
466 September 24, 2009 Contacts/Locations and Study Status
467 September 25, 2009 Contacts/Locations and Study Status
468 September 26, 2009 Contacts/Locations and Study Status
469 September 29, 2009 Contacts/Locations and Study Status
470 September 30, 2009 Contacts/Locations and Study Status
471 October 1, 2009 Contacts/Locations and Study Status
472 October 3, 2009 Study Status and Contacts/Locations
473 October 6, 2009 Contacts/Locations and Study Status
474 October 7, 2009 Contacts/Locations and Study Status
475 October 8, 2009 Contacts/Locations and Study Status
476 October 9, 2009 Contacts/Locations and Study Status
477 October 13, 2009 Contacts/Locations and Study Status
478 October 14, 2009 Contacts/Locations and Study Status
479 October 15, 2009 Contacts/Locations and Study Status
480 October 16, 2009 Contacts/Locations and Study Status
481 October 17, 2009 Contacts/Locations and Study Status
482 October 20, 2009 Contacts/Locations and Study Status
483 October 21, 2009 Contacts/Locations and Study Status
484 October 22, 2009 Contacts/Locations and Study Status
485 October 29, 2009 Contacts/Locations and Study Status
486 October 30, 2009 Contacts/Locations and Study Status
487 October 31, 2009 Contacts/Locations and Study Status
488 November 3, 2009 Contacts/Locations and Study Status
489 November 4, 2009 Contacts/Locations and Study Status
490 November 7, 2009 Contacts/Locations and Study Status
491 November 10, 2009 Contacts/Locations and Study Status
492 November 12, 2009 Contacts/Locations and Study Status
493 November 13, 2009 Contacts/Locations and Study Status
494 November 16, 2009 Contacts/Locations and Study Status
495 November 17, 2009 Contacts/Locations and Study Status
496 November 19, 2009 Contacts/Locations and Study Status
497 November 20, 2009 Contacts/Locations and Study Status
498 November 24, 2009 Contacts/Locations and Study Status
499 November 27, 2009 Contacts/Locations and Study Status
500 December 1, 2009 Contacts/Locations and Study Status
501 December 3, 2009 Study Status and Contacts/Locations
502 December 11, 2009 Contacts/Locations and Study Status
503 December 13, 2009 Contacts/Locations and Study Status
504 December 17, 2009 Contacts/Locations and Study Status
505 December 18, 2009 Contacts/Locations and Study Status
506 December 19, 2009 Contacts/Locations and Study Status
507 December 22, 2009 Contacts/Locations and Study Status
508 December 25, 2009 Contacts/Locations and Study Status
509 December 31, 2009 Contacts/Locations and Study Status
510 January 1, 2010 Contacts/Locations and Study Status
511 January 6, 2010 Study Status and Contacts/Locations
512 January 7, 2010 Contacts/Locations and Study Status
513 January 9, 2010 Contacts/Locations and Study Status
514 January 12, 2010 Contacts/Locations and Study Status
515 January 14, 2010 Contacts/Locations and Study Status
516 January 15, 2010 Contacts/Locations and Study Status
517 January 19, 2010 Contacts/Locations and Study Status
518 January 20, 2010 Contacts/Locations and Study Status
519 January 21, 2010 Contacts/Locations and Study Status
520 January 22, 2010 Contacts/Locations and Study Status
521 January 23, 2010 Contacts/Locations and Study Status
522 January 26, 2010 Contacts/Locations and Study Status
523 January 27, 2010 Contacts/Locations and Study Status
524 February 1, 2010 Contacts/Locations and Study Status
525 February 10, 2010 Study Status and Contacts/Locations
526 February 12, 2010 Contacts/Locations and Study Status
527 February 13, 2010 Contacts/Locations and Study Status
528 February 18, 2010 Contacts/Locations and Study Status
529 February 19, 2010 Contacts/Locations and Study Status
530 February 20, 2010 Contacts/Locations and Study Status
531 February 25, 2010 Contacts/Locations and Study Status
532 February 26, 2010 Contacts/Locations and Study Status
533 March 2, 2010 Contacts/Locations and Study Status
534 March 3, 2010 Study Status and Contacts/Locations
535 March 4, 2010 Contacts/Locations and Study Status
536 March 5, 2010 Contacts/Locations and Study Status
537 March 6, 2010 Contacts/Locations and Study Status
538 March 11, 2010 Contacts/Locations and Study Status
539 March 16, 2010 Contacts/Locations and Study Status
540 March 17, 2010 Contacts/Locations and Study Status
541 March 18, 2010 Contacts/Locations and Study Status
542 March 19, 2010 Contacts/Locations and Study Status
543 March 25, 2010 Contacts/Locations and Study Status
544 March 26, 2010 Contacts/Locations and Study Status
545 March 27, 2010 Contacts/Locations and Study Status
546 March 30, 2010 Contacts/Locations and Study Status
547 March 31, 2010 Contacts/Locations and Study Status
548 April 3, 2010 Study Status and Contacts/Locations
549 April 6, 2010 Contacts/Locations and Study Status
550 April 7, 2010 Contacts/Locations and Study Status
551 April 8, 2010 Contacts/Locations and Study Status
552 April 13, 2010 Contacts/Locations, Study Description and Study Status
553 May 5, 2010 Study Status and Contacts/Locations
554 May 7, 2010 Contacts/Locations and Study Status
555 July 3, 2010 Eligibility, Study Description and Study Status
556 July 28, 2010 Contacts/Locations, Sponsor/Collaborators and Study Status
557 September 17, 2010 Conditions and Study Status
558 March 1, 2011 Recruitment Status, Study Status and Contacts/Locations
559 February 8, 2012 Outcome Measures, Study Identification, Sponsor/Collaborators, Study Design, Study Status, Study Description and Oversight
560 July 26, 2012 Study Design, Study Status and Study Identification
561 April 10, 2013 Study Status
562 November 6, 2013 Study Status and Contacts/Locations
563 July 29, 2016 Contacts/Locations, Arms and Interventions, Study Identification, Study Status, Outcome Measures, Eligibility, References, Conditions, Study Description and Results
564 June 28, 2019 Outcome Measures, Study Status, Adverse Events, Baseline Characteristics, Study Identification, Document Section and Contacts/Locations
565 August 4, 2020 Study Status
566 February 12, 2021 Study Status
567 November 15, 2022 Study Status and Study Identification
568 December 14, 2023 More Information, References and Study Status
Comparison Format:
Scroll up to access the controls
Study NCT00066690
Submitted Date:  December 14, 2023 (v568)
Open or close this module Study Identification
Unique Protocol ID: IBCSG 24-02 / BIG 2-02
Brief Title: Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer (SOFT)
Official Title: A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women With Endocrine Responsive Breast Cancer
Secondary IDs: NCI-2009-01086 [Registry Identifier: CTRP (Clinical Trial Reporting Program)]
CDR0000316456
BIG 2-02
2004-000166-13
IBCSG-24-02 [CTEP]
U24CA075362 [U.S. NIH Grant/Contract]
Open or close this module Study Status
Record Verification: December 2023
Overall Status: Active, not recruiting
Study Start: December 17, 2003
Primary Completion: May 2014 [Actual]
Study Completion: December 2025 [Anticipated]
First Submitted: August 6, 2003
First Submitted that
Met QC Criteria:		 August 6, 2003
First Posted: August 7, 2003 [Estimate]
Results First Submitted: July 14, 2015
Results First Submitted that
Met QC Criteria:		 July 29, 2016
Results First Posted: September 22, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:		 December 14, 2023
Last Update Posted: January 2, 2024 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: ETOP IBCSG Partners Foundation
Responsible Party: Sponsor
Collaborators: Breast International Group
Cancer and Leukemia Group B
National Cancer Institute (NCI)
NSABP Foundation Inc
NCIC Clinical Trials Group
North Central Cancer Treatment Group
SWOG Cancer Research Network
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary:

RATIONALE: Estrogen can stimulate the growth of breast tumor cells. Ovarian function suppression combined with hormone therapy using tamoxifen or exemestane may fight breast cancer by reducing the production of estrogen. It is not yet known whether suppression of ovarian function plus either tamoxifen or exemestane is more effective than tamoxifen alone in preventing the recurrence of hormone-responsive breast cancer.

PURPOSE: This randomized phase III trial studies ovarian suppression with either tamoxifen or exemestane to see how well they work compared to tamoxifen alone in treating premenopausal women who have undergone surgery for hormone-responsive breast cancer.
Detailed Description:

OBJECTIVES:

  • Compare the disease-free survival, breast cancer-free interval, distant recurrence-free interval and overall survival of premenopausal women with endocrine-responsive breast cancer when treated with tamoxifen + ovarian function suppression (by triptorelin, oophorectomy, or ovarian irradiation) or exemestane + ovarian function suppression vs. tamoxifen alone. The primary comparison is ovarian function suppression with either tamoxifen or exemestane vs. tamoxifen alone.
  • Compare the quality of life, including late side effects of early menopause, of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, prior adjuvant/neoadjuvant chemotherapy (yes vs no), and number of positive axillary and/or internal mammary lymph nodes (0 vs 1 or more) and intended initial method of ovarian function suppression (triptorelin vs oophorectomy vs ovarian irradiation). Treatment duration is 5 years. Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter. Quality of life is assessed at baseline, every 6 months for 2 years, and then annually for 4 years.
Open or close this module Conditions
Conditions: Estrogen Receptor Positive Breast Cancer
Progesterone Receptor Positive Tumor
Recurrent Breast Carcinoma
Stage IA Breast Cancer
Stage IB Breast Cancer
Stage IIA Breast Cancer
Stage IIB Breast Cancer
Stage IIIA Breast Cancer
Keywords: tamoxifen
ovarian function suppression + tamoxifen
ovarian function suppression + exemestane
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 3066 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Tamoxifen
Tamoxifen 20mg orally daily for 5 years
Laboratory Biomarker Analysis
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Drug: Tamoxifen
Tamoxifen 20mg orally daily for 5 years
Other Names:
  • Apo-Tamox
  • Clonoxifen
  • Dignotamoxi
  • Ebefen
  • Emblon
  • Estroxyn
  • Fentamox
  • Gen-Tamoxifen
  • Genox
  • ICI 46,474
  • ICI-46474
  • Jenoxifen
  • Kessar
  • Ledertam
  • Lesporene
  • Nolgen
  • Noltam
  • Nolvadex
  • Nolvadex-D
  • Nourytam
  • Novo-Tamoxifen
  • Novofen
  • Noxitem
  • Oestrifen
  • Oncotam
  • PMS-Tamoxifen
  • Soltamox
  • TAM
  • Tamax
  • Tamaxin
  • Tamifen
  • Tamizam
  • Tamofen
  • Tamoxasta
  • TAMOXIFEN CITRATE
  • Tamoxifeni Citras
  • Zemide
Experimental: T+OFS
Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
Laboratory Biomarker Analysis
Correlative studies
Procedure: Oophorectomy
Undergo bilateral surgical oophorectomy
Other Names:
  • Female Castration
  • Ovariectomy
Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Radiation: Radiation Therapy
Undergo ovarian irradiation
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • Irradiation
  • RADIATION
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation
Drug: Tamoxifen
Tamoxifen 20mg orally daily for 5 years
Other Names:
  • Apo-Tamox
  • Clonoxifen
  • Dignotamoxi
  • Ebefen
  • Emblon
  • Estroxyn
  • Fentamox
  • Gen-Tamoxifen
  • Genox
  • ICI 46,474
  • ICI-46474
  • Jenoxifen
  • Kessar
  • Ledertam
  • Lesporene
  • Nolgen
  • Noltam
  • Nolvadex
  • Nolvadex-D
  • Nourytam
  • Novo-Tamoxifen
  • Novofen
  • Noxitem
  • Oestrifen
  • Oncotam
  • PMS-Tamoxifen
  • Soltamox
  • TAM
  • Tamax
  • Tamaxin
  • Tamifen
  • Tamizam
  • Tamofen
  • Tamoxasta
  • TAMOXIFEN CITRATE
  • Tamoxifeni Citras
  • Zemide
Drug: Triptorelin
3.75 mg by im injection q28 days for 5 years
Other Names:
  • 6-D-Tryptophan-LH-RH
  • 6-D-Tryptophanluteinizing Hormone-releasing Factor
  • AY-25650
  • CL-118,532
  • Decapeptyl
  • Detryptoreline
  • GnRH analogue
  • Trelstar Depot
  • Decapeptyl Depot
Experimental: E+OFS
Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
 Drug: Exemestane
Exemestane 25mg orally daily for 5 years plus ovarian function suppression
Other Names:
  • Aromasin
  • FCE-24304
Laboratory Biomarker Analysis
Correlative studies
Procedure: Oophorectomy
Undergo bilateral surgical oophorectomy
Other Names:
  • Female Castration
  • Ovariectomy
Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Radiation: Radiation Therapy
Undergo ovarian irradiation
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • Irradiation
  • RADIATION
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation
Drug: Triptorelin
3.75 mg by im injection q28 days for 5 years
Other Names:
  • 6-D-Tryptophan-LH-RH
  • 6-D-Tryptophanluteinizing Hormone-releasing Factor
  • AY-25650
  • CL-118,532
  • Decapeptyl
  • Detryptoreline
  • GnRH analogue
  • Trelstar Depot
  • Decapeptyl Depot
Open or close this module Outcome Measures
[See Results Section.]
Primary Outcome Measures:
1. Disease-free Survival
[ Time Frame: 5-year estimates, reported at a median follow-up of 67 months. ]

Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to the first appearance of one of the following: invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow-up.
Secondary Outcome Measures:
1. Breast Cancer-free Interval
[ Time Frame: 5-year estimates, reported at a median follow-up of 67 months. ]

Estimated percentage of patients alive and disease-free at 5 years from randomization, where breast cancer-free interval is defined as the time from randomization to invasive breast cancer recurrence at local, regional, or distant site, or invasive contralateral breast cancer; or censored at date of last follow up.
2. Distant Recurrence-free Interval
[ Time Frame: 5-year estimates, reported at a median follow-up of 67 months. ]

Estimated percentage of patients alive and disease-free at 5 years from randomization, where distant recurrence-free Interval is defined as the time from randomization to invasive breast cancer recurrence at distant site, or invasive contralateral breast cancer; or censored at date of last follow up.
3. Overall Survival
[ Time Frame: 8-year estimates, reported at a median follow-up of 8 years ]

Estimated percentage of patients alive at 8 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 65 Years
Sex: Female
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Premenopausal women (estradiol [E2] in the premenopausal range [according to institution parameters]) who meet the following criteria:
    • Patients who did not receive chemotherapy should be randomized within 12 weeks after definitive surgery; such patients should have estradiol (E2) in the premenopausal range following surgery; the only patients who do not require testing of estradiol (E2) to confirm premenopausal status are those who have been menstruating regularly during the 6 months prior to randomization and have not used any form of hormonal contraception or any other hormonal treatments during the 6 months prior to randomization
    • Patients who received prior adjuvant and/or neoadjuvant chemotherapy should be randomized after completing chemotherapy and within 8 months of the final dose of chemotherapy as soon as premenopausal status is confirmed; all such patients should have premenopausal status confirmed by an estradiol (E2) in the premenopausal range between 2 weeks and 8 months after completing chemotherapy
    • Adjuvant trastuzumab (Herceptin ®) is allowable, and is not considered to be chemotherapy for eligibility timing determination
    • Patients with temporary chemotherapy-induced amenorrhea who regain premenopausal status within eight months of the final dose of chemotherapy are eligible; (please note that some patients taking tamoxifen or aromatase inhibitors, even without evidence of menses, may have ovarian function recovery following chemotherapy and resume estradiol secretion); in patients wishing to participate in the study, with postmenopausal hormone levels shortly after chemotherapy, it is recommended to recheck their estradiol level at a later timepoint within 8 months of completing chemotherapy, even in the absence of return of menses
  • Histologically proven, resected breast cancer; pathology material should be available for submission for central review as part of the quality control measures for this protocol
  • Patients must have hormone receptor positive tumors; if there is more than one breast tumor, each tumor must be hormone receptor positive; hormone receptors must be determined using immunohistochemistry; estrogen receptor (ER) and/or progesterone receptor (PgR) must be greater than or equal to 10% of the tumor cells positive by immunohistochemical evaluation; biochemical determination alone is not acceptable
  • The tumor must be confined to the breast and axillary nodes without detected metastases elsewhere, with the exception of tumor detected in internal mammary chain nodes by sentinel node procedure; patients who received neoadjuvant therapy must have had operable disease prior to neoadjuvant treatment to be eligible; patients who had a pathological evaluation with tru cut or core biopsy of invasive breast cancer prior to neoadjuvant therapy and were found to have no invasive tumor in the pathological specimen from definitive surgery are eligible; for these patients, pre-neoadjuvant tumor characteristics will be used for defining eligibility; in case of persistent disease, pathology findings from the definitive surgery should be used
  • Patients must have had proper surgery for primary breast cancer with no known clinical residual loco-regional disease:
    • A total mastectomy; radiotherapy is optional after mastectomy OR
    • A breast-conserving procedure (lumpectomy, quadrantectomy or partial mastectomy with margins clear of invasive cancer and ductal breast carcinoma in situ [DCIS]); the local pathologist must document negative margins of resection in the pathology report; if all other margins are clear, a positive posterior (deep) margin is permitted, provided the surgeon documents that the excision was performed down to the pectoral fascia and all tumor has been removed; likewise, if all other margins are clear, a positive anterior (superficial; abutting skin) margin is permitted provided the surgeon documents that all tumor has been removed; radiation therapy to the conserved breast is required; patients may be randomized before, during or after completion of radiation therapy to the breast
  • Either axillary lymph node dissection (pathological examination of at least 6 nodes recommended) or a negative axillary sentinel node biopsy (pN0[sn]) is required; patients with negative or microscopically axillary positive sentinel nodes (pN1mi: micrometastasis none > 2.0 mm) do not require further axillary therapy; those with positive sentinel nodes must have either an axillary dissection or radiation of axillary nodes
  • For International Breast Cancer Study Groups (IBCSG) centers, patients must have completed baseline Quality of Life (QL) Forms prior to randomization; the only exceptions are cognitive or physical impairment that interferes with QL assessment or inability to read any of the languages available on IBCSG QL forms; for non-IBCSG centers, extent of participation in the QL study is to be determined at the activation of the trial for each cooperative group
  • Written informed consent must be signed and dated by the patient and the investigator prior to randomization
  • Patients must be accessible for follow-up
  • Patients must be informed of and agree to data and tissue material transfer and handling, in accordance with national data protection guidelines

Exclusion Criteria:

  • Patients who are postmenopausal (i.e., do not have an estradiol [E2] level in the premenopausal range) after surgery or after chemotherapy, whichever is later
  • Patients with distant metastatic disease
  • Patients with locally advanced inoperable breast cancer including inflammatory breast cancer or supraclavicular node involvement or with enlarged internal mammary nodes (unless pathologically negative) are not eligible; patients with involved internal mammary nodes detected by sentinel node biopsy that are not enlarged are eligible
  • Patients with positive final margins (referring to only DCIS and invasive cancer, not lobular breast carcinoma in situ [LCIS]), except as noted; DCIS at a margin is permitted if a complete mastectomy has been performed
  • Patients with clinically detectable residual axillary disease
  • Patients with a history of prior ipsilateral or contralateral invasive breast cancer; patients with synchronous bilateral invasive breast cancer (diagnosed histologically within 2 months) are eligible if the bilateral disease meets all other eligibility criteria
  • Patients with previous or concomitant invasive malignancy are not eligible; the exceptions are patients with the following (and only the following) malignancies (previous or concomitant) who are eligible if adequately treated:
    • Basal or squamous cell carcinoma of the skin
    • In situ non-breast carcinoma without invasion
    • Contra- or ipsilateral in situ breast carcinoma
    • Non-breast invasive malignancy diagnosed at least 5 years ago and without recurrence:
      • Stage I papillary thyroid cancer
      • Stage Ia carcinoma of the cervix
      • Stage Ia or b endometrioid endometrial cancer
      • Borderline or stage I ovarian cancer
  • Patients with other non-malignant systemic diseases (cardiovascular, renal, hepatic, lung, etc.) that would prevent prolonged follow-up; patients with previous thrombosis (e.g., deep vein thrombosis [DVT]) and/or embolism can be included only if medically suitable
  • Patients who have had a bilateral oophorectomy or ovarian irradiation; patients who will be recommended to undergo oophorectomy within 5 years (e.g., breast cancer susceptibility gene [BRCA]1/2 gene carriers) and therefore for whom randomization to a treatment arm without OFS is inappropriate
  • Patients with a history of noncompliance to medical regimens and patients who are considered potentially unreliable
  • Patients who are pregnant or lactating at the time of randomization or who desire a pregnancy within 5 years; patients planning to use additional hormonal therapy apart from the randomized treatment during the next five years including all types of hormonal contraception; a pregnancy test is recommended for women of child-bearing potential who are sexually active and not using reliable contraceptive methods
  • Patients who received endocrine therapy (including neoadjuvant and adjuvant) for more than 8 months after their breast cancer diagnosis; patients who are receiving endocrine therapy at randomization (and have received it for less than 8 months) may continue such therapy until protocol-specified tamoxifen/exemestane is initiated
  • Patients who were taking tamoxifen or other selective estrogen receptor modulator (SERM) (e.g. Raloxifene) or hormone replacement therapy (HRT) within one year prior to their breast cancer diagnosis; prior oral contraceptives are allowed
  • Patients who have received GnRH analogues as part of their breast cancer treatment prior to randomization
  • Patients with psychiatric, addictive, or any disorder that would prevent compliance with protocol requirements
Open or close this module Contacts/Locations
Study Officials: Gini Fleming
Principal Investigator
ETOP IBCSG Partners Foundation
Locations: United States, Alabama
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
United States, Alaska
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
United States, California
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States, 94704
Mills - Peninsula Hospitals
Burlingame, California, United States, 94010
East Bay Radiation Oncology Center
Castro Valley, California, United States, 94546
Valley Medical Oncology Consultants-Castro Valley
Castro Valley, California, United States, 94546
John Muir Medical Center-Concord Campus
Concord, California, United States, 94520
Bay Area Breast Surgeons Inc
Emeryville, California, United States, 94608
Kaiser Permanente-Fremont
Fremont, California, United States, 94538
Valley Medical Oncology Consultants-Fremont
Fremont, California, United States, 94538
Glendale Memorial Hospital and Health Center
Glendale, California, United States, 91204
Marin General Hospital
Greenbrae, California, United States, 94904
Scripps Cancer Center
La Jolla, California, United States, 92037
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Contra Costa Regional Medical Center
Martinez, California, United States, 94553-3156
Memorial Medical Center
Modesto, California, United States, 95355
Palo Alto Medical Foundation-Camino Division
Mountain View, California, United States, 94040
Sutter Cancer Research Consortium
Novato, California, United States, 94945
Bay Area Tumor Institute
Oakland, California, United States, 94609
Hematology and Oncology Associates-Oakland
Oakland, California, United States, 94609
Tom K Lee Inc
Oakland, California, United States, 94609
Kaiser Permanente-Oakland
Oakland, California, United States, 94611
Palo Alto Medical Foundation Health Care
Palo Alto, California, United States, 94301
Stanford Cancer Institute
Palo Alto, California, United States, 94304
Valley Medical Oncology Consultants
Pleasanton, California, United States, 94588
Eisenhower Medical Center
Rancho Mirage, California, United States, 92270
Mercy Regional Cancer Center
Redding, California, United States, 96001
Kaiser Permanente-Redwood City
Redwood City, California, United States, 94063
Kaiser Permanente-Richmond
Richmond, California, United States, 94801
Kaiser Permanente-Roseville
Roseville, California, United States, 95661
Mercy General Hospital
Sacramento, California, United States, 95819
Kaiser Permanente-South Sacramento
Sacramento, California, United States, 95823
Kaiser Permanente - Sacramento
Sacramento, California, United States, 95825
Salinas Valley Memorial
Salinas, California, United States, 93901
University of California San Diego
San Diego, California, United States, 92103
Kaiser Permanente-San Diego Mission
San Diego, California, United States, 92108
Veterans Administration-San Diego Medical Center
San Diego, California, United States, 92161
San Francisco General Hospital
San Francisco, California, United States, 94110
California Pacific Medical Center-Pacific Campus
San Francisco, California, United States, 94115
Kaiser Permanente-San Francisco
San Francisco, California, United States, 94115
UCSF Medical Center-Mount Zion
San Francisco, California, United States, 94115
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, United States, 95119
Kaiser Permanente San Leandro
San Leandro, California, United States, 94577
Kaiser Permanente-San Rafael
San Rafael, California, United States, 94903
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States, 95051
Kaiser Permanente-Santa Rosa
Santa Rosa, California, United States, 95403
Santa Rosa Memorial Hospital
Santa Rosa, California, United States, 95405
Kaiser Permanente-South San Francisco
South San Francisco, California, United States, 94080
Kaiser Permanente-Vallejo
Vallejo, California, United States, 94589
Kaiser Permanente-Walnut Creek
Walnut Creek, California, United States, 94596
John Muir Medical Center-Walnut Creek
Walnut Creek, California, United States, 94598
United States, Colorado
The Medical Center of Aurora
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States, 80907
Memorial Hospital Colorado Springs
Colorado Springs, Colorado, United States, 80909
Denver Health Medical Center
Denver, Colorado, United States, 80204
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States, 80218
SCL Health Saint Joseph Hospital
Denver, Colorado, United States, 80218
Denver Veterans Administration Medical Center
Denver, Colorado, United States, 80220
Rose Medical Center
Denver, Colorado, United States, 80220
Colorado Cancer Research Program NCORP
Denver, Colorado, United States, 80222
The Shaw Regional Cancer Center
Edwards, Colorado, United States, 81632
Swedish Medical Center
Englewood, Colorado, United States, 80113
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
Front Range Cancer Specialists
Fort Collins, Colorado, United States, 80528
North Colorado Medical Center
Greeley, Colorado, United States, 80631
Saint Anthony Hospital
Lakewood, Colorado, United States, 80228
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
Longmont United Hospital
Longmont, Colorado, United States, 80501
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States, 81004
North Suburban Medical Center
Thornton, Colorado, United States, 80229
SCL Health Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
Norwalk Hospital
Norwalk, Connecticut, United States, 06856
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States, 06360
Stamford Hospital/Bennett Cancer Center
Stamford, Connecticut, United States, 06904
Charlotte Hungerford Hospital Center for Cancer Care
Torrington, Connecticut, United States, 06790
United States, Delaware
Bayhealth Medical Center at Kent General
Dover, Delaware, United States, 19901
Beebe Medical Center
Lewes, Delaware, United States, 19958
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
Nanticoke Memorial Hospital
Seaford, Delaware, United States, 19973
United States, District of Columbia
MedStar Georgetown University Hospital
Washington, District of Columbia, United States, 20007
MedStar Washington Hospital Center
Washington, District of Columbia, United States, 20010
Sibley Memorial Hospital
Washington, District of Columbia, United States, 20016
United States, Florida
Cancer Research Network Inc
Boca Raton, Florida, United States, 33428
Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, United States, 33021
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States, 32207
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Jupiter Medical Center
Jupiter, Florida, United States, 33458
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Florida Cancer Specialists - Sarasota Downtown
Sarasota, Florida, United States, 34236
United States, Georgia
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Atlanta Regional CCOP
Atlanta, Georgia, United States, 30342
Northside Hospital
Atlanta, Georgia, United States, 30342
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, United States, 30342
Augusta Oncology Associates PC-Saint Sebastian
Augusta, Georgia, United States, 30901
Well Star Cobb Hospital
Austell, Georgia, United States, 30106
John B Amos Cancer Center
Columbus, Georgia, United States, 31904
Dekalb Medical Center
Decatur, Georgia, United States, 30033
Gwinnett Medical Center
Lawrenceville, Georgia, United States, 30045
Wellstar Kennestone Hospital
Marietta, Georgia, United States, 30060
Southern Regional Medical Center
Riverdale, Georgia, United States, 30274
Harbin Clinic Medical Oncology and Clinical Research
Rome, Georgia, United States, 30165
Memorial University Medical Center
Savannah, Georgia, United States, 31404
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, United States, 31405
United States, Hawaii
University of Hawaii Cancer Center
Honolulu, Hawaii, United States, 96813
Tripler Army Medical Center
Honolulu, Hawaii, United States, 96859
United States, Illinois
Saint Joseph Medical Center
Bloomington, Illinois, United States, 61701
Graham Hospital Association
Canton, Illinois, United States, 61520
Memorial Hospital
Carthage, Illinois, United States, 62321
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States, 60612
Rush University Medical Center
Chicago, Illinois, United States, 60612
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Heartland Cancer Research NCORP
Decatur, Illinois, United States, 62526
Eureka Hospital
Eureka, Illinois, United States, 61530
Galesburg Cottage Hospital
Galesburg, Illinois, United States, 61401
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States, 61401
Western Illinois Cancer Treatment Center
Galesburg, Illinois, United States, 61401
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Mason District Hospital
Havana, Illinois, United States, 62644
Hopedale Medical Complex - Hospital
Hopedale, Illinois, United States, 61747
Kewanee Hospital
Kewanee, Illinois, United States, 61443
Mcdonough District Hospital
Macomb, Illinois, United States, 61455
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Edward Hospital/Cancer Center
Naperville, Illinois, United States, 60540
Bromenn Regional Medical Center
Normal, Illinois, United States, 61761
Community Cancer Center Foundation
Normal, Illinois, United States, 61761
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, United States, 61350
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois, United States, 61554
Pekin Hospital
Pekin, Illinois, United States, 61554
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61603
Proctor Hospital
Peoria, Illinois, United States, 61614
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Illinois Valley Hospital
Peru, Illinois, United States, 61354
Valley Radiation Oncology
Peru, Illinois, United States, 61354
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
OSF Saint Anthony Medical Center
Rockford, Illinois, United States, 61108
Sarah Culbertson Memorial Hospital
Rushville, Illinois, United States, 62681
Saint Margaret's Hospital
Spring Valley, Illinois, United States, 61362
Memorial Medical Center
Springfield, Illinois, United States, 62781
Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, United States, 46845
Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, United States, 46202
Community Hospital East
Indianapolis, Indiana, United States, 46219
Community Regional Cancer Care-North
Indianapolis, Indiana, United States, 46256
Saint Vincent Hospital and Health Care Center
Indianapolis, Indiana, United States, 46260
IU Health La Porte Hospital
La Porte, Indiana, United States, 46350
IU Health Arnett Cancer Care
Lafayette, Indiana, United States, 47904
Horizon Oncology Center
Lafayette, Indiana, United States, 47905
Saint Joseph Regional Medical Center - Mishawaka
Mishawaka, Indiana, United States, 46545
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46628
United States, Iowa
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States, 50010
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, United States, 52402
Saint Luke's Hospital
Cedar Rapids, Iowa, United States, 52402
Mercy Hospital
Cedar Rapids, Iowa, United States, 52403
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States, 52403
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States, 50325
Genesis Medical Center - East Campus
Davenport, Iowa, United States, 52803
Mercy Capitol
Des Moines, Iowa, United States, 50307
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States, 50314
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
Finley Hospital
Dubuque, Iowa, United States, 52001
Medical Associates Clinic PC
Dubuque, Iowa, United States, 52001
Mercy Medical Center - North Iowa
Mason City, Iowa, United States, 50401
Siouxland Regional Cancer Center
Sioux City, Iowa, United States, 51101
United States, Kansas
Memorial Hospital of Arkansas City
Arkansas City, Kansas, United States, 67005
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Cancer Center of Kansas - McPherson
McPherson, Kansas, United States, 67460
Cancer Center of Kansas - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas - Salina
Salina, Kansas, United States, 67401
Saint Francis Hospital and Medical Center - Topeka
Topeka, Kansas, United States, 66606
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States, 67152
Associates In Womens Health
Wichita, Kansas, United States, 67208
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas - Main Office
Wichita, Kansas, United States, 67214
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Wichita NCI Community Oncology Research Program
Wichita, Kansas, United States, 67214
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States, 67156
United States, Louisiana
Louisiana State University Health Sciences Center Shreveport
Shreveport, Louisiana, United States, 71103
United States, Maine
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
Mercy Hospital
Portland, Maine, United States, 04101
United States, Maryland
Anne Arundel Medical Center
Annapolis, Maryland, United States, 21401
Harbor Hospital Center
Baltimore, Maryland, United States, 21225
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Suburban Hospital
Bethesda, Maryland, United States, 20814
Union Hospital of Cecil County
Elkton, Maryland, United States, 21921
Kaiser Permanente - Largo Medical Center
Largo, Maryland, United States, 20774
Kaiser Permanente - Towson Medical Center
Lutherville, Maryland, United States, 21093
Kaiser Permanente - Shady Grove Medical Center
Rockville, Maryland, United States, 20850
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Brigham and Women's Faulkner Hospital
Boston, Massachusetts, United States, 02130
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States, 01805
Emerson Hospital/MGH Cancer Center
Concord, Massachusetts, United States, 01742
Mass General/North Shore Cancer Center
Danvers, Massachusetts, United States, 01923
MetroWest Medical Center-Framingham Union Hospital
Framingham, Massachusetts, United States, 01702
Lowell General Hospital
Lowell, Massachusetts, United States, 01854
Newton-Wellesley Hospital
Newton, Massachusetts, United States, 02462
South Shore Hospital
South Weymouth, Massachusetts, United States, 02190
United States, Michigan
Bixby Medical Center
Adrian, Michigan, United States, 49221
Hickman Cancer Center
Adrian, Michigan, United States, 49221
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, United States, 48106
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Green Bay Oncology - Escanaba
Escanaba, Michigan, United States, 49829
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, United States, 48532
Cancer Research Consortium of West Michigan NCORP
Grand Rapids, Michigan, United States, 49503
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, United States, 49801
Allegiance Health
Jackson, Michigan, United States, 49201
Marquette General Hospital
Marquette, Michigan, United States, 49855
Mid-Michigan Medical Center - Midland
Midland, Michigan, United States, 48670
Mercy Memorial Hospital
Monroe, Michigan, United States, 48162
Toledo Clinic Cancer Centers-Monroe
Monroe, Michigan, United States, 48162
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States, 48073
Saint Mary's of Michigan
Saginaw, Michigan, United States, 48601
Lakeland Hospital
Saint Joseph, Michigan, United States, 49085
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Essentia Health Cancer Center
Duluth, Minnesota, United States, 55805
Fairview-Southdale Hospital
Edina, Minnesota, United States, 55435
Unity Hospital
Fridley, Minnesota, United States, 55432
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Meeker County Memorial Hospital
Litchfield, Minnesota, United States, 55355
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States, 55109
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States, 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States, 55407
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States, 55422
Mayo Clinic
Rochester, Minnesota, United States, 55905
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, United States, 55416
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital
Saint Paul, Minnesota, United States, 55101
Saint Joseph's Hospital - Healtheast
Saint Paul, Minnesota, United States, 55102
United Hospital
Saint Paul, Minnesota, United States, 55102
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States, 55379
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Minnesota Oncology and Hematology PA-Woodbury
Woodbury, Minnesota, United States, 55125
Woodwinds Health Campus
Woodbury, Minnesota, United States, 55125
United States, Mississippi
Keesler Medical Center
Keesler Air Force Base, Mississippi, United States, 39534
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Saint Anthony's Medical Center
Saint Louis, Missouri, United States, 63128
Missouri Baptist Medical Center
Saint Louis, Missouri, United States, 63131
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
United States, Montana
Montana Cancer Consortium NCORP
Billings, Montana, United States, 59101
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Benefis Healthcare-West Campus
Great Falls, Montana, United States, 59405
Great Falls Clinic
Great Falls, Montana, United States, 59405
United States, Nebraska
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
United States, Nevada
Renown Regional Medical Center
Reno, Nevada, United States, 89502
United States, New Hampshire
New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire, United States, 03301
Exeter Hospital
Exeter, New Hampshire, United States, 03833
New Hampshire Oncology Hematology PA-Hooksett
Hooksett, New Hampshire, United States, 03106
Cheshire Medical Center-Dartmouth-Hitchcock Keene
Keene, New Hampshire, United States, 03431
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Elliot Hospital
Manchester, New Hampshire, United States, 03103
Frisbie Hospital
Rochester, New Hampshire, United States, 03867
United States, New Jersey
Cooper Hospital University Medical Center
Camden, New Jersey, United States, 08103
The Cancer Institute of New Jersey Hamilton
Hamilton, New Jersey, United States, 08690
Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07039
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740
Morristown Medical Center
Morristown, New Jersey, United States, 07960
Virtua Memorial
Mount Holly, New Jersey, United States, 08060
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Inspira Medical Center Vineland
Vineland, New Jersey, United States, 08360
Virtua Voorhees
Voorhees, New Jersey, United States, 08043
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87102
Hematology Oncology Associates
Albuquerque, New Mexico, United States, 87106
Presbyterian Kaseman Hospital
Albuquerque, New Mexico, United States, 87110
United States, New York
Montefiore Medical Center-Weiler Hospital
Bronx, New York, United States, 10461
Montefiore Medical Center - Moses Campus
Bronx, New York, United States, 10467-2490
Kings County Hospital
Brooklyn, New York, United States, 11203
State University of New York Downstate Medical Center
Brooklyn, New York, United States, 11203
University Hospital of Brooklyn
Brooklyn, New York, United States, 11203
Brookdale Hospital Medical Center
Brooklyn, New York, United States, 11212
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Adirondack Cancer Center
Glens Falls, New York, United States, 12801
Northwell Health NCORP
Lake Success, New York, United States, 11042
North Shore University Hospital
Manhasset, New York, United States, 11030
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Saint Vincent's Hospital and Medical Center of New York
New York, New York, United States, 10011
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Weill Medical College of Cornell University
New York, New York, United States, 10065
Staten Island University Hospital
Staten Island, New York, United States, 10305
United States, North Carolina
Mission Hospital-Memorial Campus
Asheville, North Carolina, United States, 28801
Hope Women's Cancer Centers-Asheville
Asheville, North Carolina, United States, 28816
Cone Health Cancer Center at Alamance Regional
Burlington, North Carolina, United States, 27216
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Carolinas HealthCare System NorthEast
Concord, North Carolina, United States, 28025
Wayne Memorial Hospital
Goldsboro, North Carolina, United States, 27534
FirstHealth of the Carolinas-Moore Regional Hosiptal
Pinehurst, North Carolina, United States, 28374
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
Southeast Clinical Oncology Research (SCOR) Consortium NCORP
Winston-Salem, North Carolina, United States, 27104
United States, North Dakota
Mid Dakota Clinic
Bismarck, North Dakota, United States, 58501
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States, 58501
Altru Cancer Center
Grand Forks, North Dakota, United States, 58201
Altru Hospital
Grand Forks, North Dakota, United States, 58201
Trinity Cancer Care Center
Minot, North Dakota, United States, 58701
United States, Ohio
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green, Ohio, United States, 43402
Aultman Health Foundation
Canton, Ohio, United States, 44710
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Case Western Reserve University
Cleveland, Ohio, United States, 44106
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States, 44111
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Columbus NCI Community Oncology Research Program
Columbus, Ohio, United States, 43215
Grant Medical Center
Columbus, Ohio, United States, 43215
Mount Carmel Health Center West
Columbus, Ohio, United States, 43222
Doctors Hospital
Columbus, Ohio, United States, 43228
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States, 45406
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Samaritan North Health Center
Dayton, Ohio, United States, 45415
Dayton NCI Community Oncology Research Program
Dayton, Ohio, United States, 45420
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Kettering Medical Center
Kettering, Ohio, United States, 45429
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Lima Memorial Hospital
Lima, Ohio, United States, 45804
Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, United States, 43537
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Maumee, Ohio, United States, 43537
Licking Memorial Hospital
Newark, Ohio, United States, 43055
Saint Charles Hospital
Oregon, Ohio, United States, 43616
Toledo Clinic Cancer Centers-Oregon
Oregon, Ohio, United States, 43616
North Coast Cancer Care
Sandusky, Ohio, United States, 44870
Springfield Regional Medical Center
Springfield, Ohio, United States, 45505
Flower Hospital
Sylvania, Ohio, United States, 43560
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, United States, 43606
Saint Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
University of Toledo
Toledo, Ohio, United States, 43614
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, United States, 43617
Mercy Saint Anne Hospital
Toledo, Ohio, United States, 43623
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, United States, 43623
Upper Valley Medical Center
Troy, Ohio, United States, 45373
Fulton County Health Center
Wauseon, Ohio, United States, 43567
Saint Ann's Hospital
Westerville, Ohio, United States, 43081
Cleveland Clinic Wooster Family Health and Surgery Center
Wooster, Ohio, United States, 44691
Greene Memorial Hospital
Xenia, Ohio, United States, 45385
Tod Children's Hospital - Forum Health
Youngstown, Ohio, United States, 44501
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, United States, 43701
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Bend Memorial Clinic
Bend, Oregon, United States, 97701
Saint Charles Medical Center-Bend
Bend, Oregon, United States, 97701
Legacy Mount Hood Medical Center
Gresham, Oregon, United States, 97030
Providence Milwaukie Hospital
Milwaukie, Oregon, United States, 97222
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, United States, 97210
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Western Oncology Research Consortium
Portland, Oregon, United States, 97213
Providence Saint Vincent Medical Center
Portland, Oregon, United States, 97225
Kaiser Permanente
Portland, Oregon, United States, 97227
Legacy Emanuel Hospital and Health Center
Portland, Oregon, United States, 97227
Legacy Meridian Park Hospital
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, United States, 18103
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, United States, 18015
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States, 18201
Penn State Hershey Cancer Institute-Clinical Trials Office
Hershey, Pennsylvania, United States, 17033-0850
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17604
Saint Mary Medical and Regional Cancer Center
Langhorne, Pennsylvania, United States, 19047
Lewistown Hospital
Lewistown, Pennsylvania, United States, 17044
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Aria Health-Torresdale Campus
Philadelphia, Pennsylvania, United States, 19114
Chestnut Hill Health System
Philadelphia, Pennsylvania, United States, 19118
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, United States, 18840
Scranton Hematology Oncology
Scranton, Pennsylvania, United States, 18510
Grand View Hospital
Sellersville, Pennsylvania, United States, 18960
Geisinger Medical Group
State College, Pennsylvania, United States, 16801
Mount Nittany Medical Center
State College, Pennsylvania, United States, 16803
Chester County Hospital
West Chester, Pennsylvania, United States, 19380
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States, 18711
WellSpan Health-York Hospital
York, Pennsylvania, United States, 17403
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Women and Infants Hospital
Providence, Rhode Island, United States, 02905
Miriam Hospital
Providence, Rhode Island, United States, 02906
United States, South Carolina
AnMed Health Hospital
Anderson, South Carolina, United States, 29621
Spartanburg Medical Center
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Sanford Cancer Center-Oncology Clinic
Sioux Falls, South Dakota, United States, 57104
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, United States, 57105
Medical X-Ray Center
Sioux Falls, South Dakota, United States, 57105
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
United States, Tennessee
Erlanger Medical Center
Chattanooga, Tennessee, United States, 37403
Memorial Hospital
Chattanooga, Tennessee, United States, 37404
Jones Clinic
Germantown, Tennessee, United States, 38138
Thompson Cancer Survival Center
Knoxville, Tennessee, United States, 37916
Nashville Oncology Associates PC
Nashville, Tennessee, United States, 37203
Meharry Medical College
Nashville, Tennessee, United States, 37208
United States, Texas
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Zale Lipshy University Hospital
Dallas, Texas, United States, 75235
Clements University Hospital
Dallas, Texas, United States, 75390
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States, 77030
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Doctor's Hospital of Laredo
Laredo, Texas, United States, 78041
Covenant Medical Center-Lakeside
Lubbock, Texas, United States, 79410
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Scott and White Memorial Hospital
Temple, Texas, United States, 76508
United States, Vermont
Southwestern Vermont Medical Center
Bennington, Vermont, United States, 05201
Central Vermont Medical Center/National Life Cancer Treatment
Berlin, Vermont, United States, 05602
University of Vermont College of Medicine
Burlington, Vermont, United States, 05405
United States, Virginia
Kaiser Permanente - Fair Oaks Medical Center
Fairfax, Virginia, United States, 22033
Fredericksburg Oncology Inc
Fredericksburg, Virginia, United States, 22401
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States, 23298
United States, Washington
MultiCare Auburn Medical Center
Auburn, Washington, United States, 98001
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, United States, 98225
Providence Regional Cancer System-Centralia
Centralia, Washington, United States, 98531
Saint Francis Hospital
Federal Way, Washington, United States, 98003
Saint Clare Hospital
Lakewood, Washington, United States, 98499
Providence - Saint Peter Hospital
Olympia, Washington, United States, 98506-5166
MultiCare Good Samaritan Hospital
Puyallup, Washington, United States, 98372
Group Health Cooperative of Puget Sound Oncology Consortium
Seattle, Washington, United States, 98112
Group Health Cooperative-Seattle
Seattle, Washington, United States, 98112
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122-4307
University of Washington Medical Center
Seattle, Washington, United States, 98195
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
MultiCare Allenmore Hospital
Tacoma, Washington, United States, 98405
Northwest NCI Community Oncology Research Program
Tacoma, Washington, United States, 98405
Saint Joseph Medical Center
Tacoma, Washington, United States, 98405
Multicare Health System
Tacoma, Washington, United States, 98415
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States, 98664
United States, West Virginia
Edwards Comprehensive Cancer Center
Huntington, West Virginia, United States, 25701
United States, Wisconsin
Langlade Hospital and Cancer Center
Antigo, Wisconsin, United States, 54409
Sacred Heart Hospital
Eau Claire, Wisconsin, United States, 54701
Midelfort Clinic-Clairemont Campus
Eau Claire, Wisconsin, United States, 54702
Aurora Cancer Care-Southern Lakes
Elkhorn, Wisconsin, United States, 53121
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301-3526
Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States, 54311-6519
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
UW Health Oncology-One South Park
Madison, Wisconsin, United States, 53715
Dean Hematology and Oncology Clinic
Madison, Wisconsin, United States, 53717
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Holy Family Memorial Hospital
Manitowoc, Wisconsin, United States, 54221
Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Vince Lombardi Cancer Clinic-Marinette
Marinette, Wisconsin, United States, 54143
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Medical Consultants Limited
Milwaukee, Wisconsin, United States, 53215
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, United States, 54548
Green Bay Oncology - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
Aspirus Regional Cancer Center
Wausau, Wisconsin, United States, 54401
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
BCCA-Cancer Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
Penticton Regional Hospital
Penticton, British Columbia, Canada, V2A 3G6
BCCA-Fraser Valley Cancer Centre
Surrey, British Columbia, Canada, V3V 1Z2
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Newfoundland and Labrador
Doctor H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Ontario
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 5C2
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada, K7L 5P9
London Regional Cancer Program
London, Ontario, Canada, N6A 4L6
Ottawa Hospital and Cancer Center-General Campus
Ottawa, Ontario, Canada, K1H 8L6
Health Sciences North
Sudbury, Ontario, Canada, P3E 5J1
Thunder Bay Regional Health Science Centre
Thunder Bay, Ontario, Canada, P7B 6V4
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
CSSS Champlain-Charles Le Moyne
Greenfield Park, Quebec, Canada, J4V 2H1
CHUM-Hotel Dieu du Montreal
Montreal, Quebec, Canada, H2W 1T8
Hopital Du Sacre-Coeur de Montreal
Montreal, Quebec, Canada, H4J 1C5
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Switzerland
International Breast Cancer Study Group
Bern, Switzerland, 3008
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations: [Study Results] Francis PA, Regan MM, Fleming GF, Lang I, Ciruelos E, Bellet M, Bonnefoi HR, Climent MA, Da Prada GA, Burstein HJ, Martino S, Davidson NE, Geyer CE Jr, Walley BA, Coleman R, Kerbrat P, Buchholz S, Ingle JN, Winer EP, Rabaglio-Poretti M, Maibach R, Ruepp B, Giobbie-Hurder A, Price KN, Colleoni M, Viale G, Coates AS, Goldhirsch A, Gelber RD; SOFT Investigators; International Breast Cancer Study Group. Adjuvant ovarian suppression in premenopausal breast cancer. N Engl J Med. 2015 Jan 29;372(5):436-46. doi: 10.1056/NEJMoa1412379. Epub 2014 Dec 11. PubMed 25495490
[Study Results] Francis PA, Fleming GF, Lang I, Ciruelos EM, Bonnefoi HR, Bellet M, Bernardo A, Climent MA, Martino S, Bermejo B, Burstein HJ, Davidson NE, Geyer CE Jr, Walley BA, Ingle JN, Coleman RE, Muller B, Le Du F, Loibl S, Winer EP, Ruepp B, Loi S, Colleoni M, Coates AS, Gelber RD, Goldhirsch A, Regan MM; SOFT Investigators and the International Breast Cancer Study Group (a division of ETOP IBCSG Partners Foundation). Adjuvant Endocrine Therapy in Premenopausal Breast Cancer: 12-Year Results From SOFT. J Clin Oncol. 2023 Mar 1;41(7):1370-1375. doi: 10.1200/JCO.22.01065. Epub 2022 Dec 9. Erratum In: J Clin Oncol. 2023 Sep 1;41(25):4187. PubMed 36493334
Links:
Available IPD/Information:
Open or close this module Document Section
Study Protocol
Document Date: July 14, 2011
Uploaded: 05/30/2019 11:26
File Name: Prot_001.pdf
Statistical Analysis Plan
Document Date: November 1, 2017
Uploaded: 05/30/2019 11:16
File Name: SAP_000.pdf
Study Results
Open or close this module Participant Flow
Recruitment Details 3066 patients were randomized between 17Dec03 and 27Jan11 at 426 centers in 25 countries.
Pre-assignment Details
 
Arm/Group Title Tamoxifen T+OFS E+OFS
Arm/Group Description Tamoxifen 20mg orally daily for 5 years Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation) Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
Period Title: Overall Study
Started 1021 1024 1021
Completed 423 502 457
Not Completed 598 522 564
Reason Not Completed
Adverse Event 145 58 126
Death 3 0 2
Lack of Efficacy 114 110 76
Lost to Follow-up 40 21 29
Withdrawal by Subject 50 55 49
Treatment Ongoing 246 278 282
Open or close this module Baseline Characteristics
Arm/Group TitleTamoxifenT+OFSE+OFSTotal
Arm/Group DescriptionTamoxifen 20mg orally daily for 5 yearsTamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)Total of all reporting groups
Overall Number of Baseline Participants 1018 1015 1014 3047
Baseline Analysis Population Description
Age, Continuous
Median (Inter-Quartile Range)
Unit of measure: years
Number Analyzed1018 Participants1015 Participants1014 Participants3047 Participants
43(38 to 46)43(38 to 47)43(38 to 47)43(38 to 47)
Sex/Gender, Customized [1]
Measure Type: Number
Unit of measure: percent of participants
Number Analyzed1018 Participants1015 Participants1014 Participants3047 Participants
Female
100100100300
Male
0000
 
[1]Measure Description: Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.
Race/Ethnicity, Customized
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed1018 Participants1015 Participants1014 Participants3047 Participants
American Indian/Alaskan native
1
0.1%
5
0.49%
3
0.3%
9
0.3%
Asian
36
3.54%
34
3.35%
33
3.25%
103
3.38%
Black/African American
32
3.14%
27
2.66%
34
3.35%
93
3.05%
Hawaiian/Pacific Islander
5
0.49%
4
0.39%
3
0.3%
12
0.39%
White/Caucasian
877
86.15%
873
86.01%
866
85.4%
2616
85.85%
Other
4
0.39%
2
0.2%
3
0.3%
9
0.3%
Unknown
19
1.87%
22
2.17%
22
2.17%
63
2.07%
Hispanic/Latino/South American native
44
4.32%
48
4.73%
50
4.93%
142
4.66%
Lymph-node status [1]
Measure Type: Number
Unit of measure: percent of participants
Number Analyzed1018 Participants1015 Participants1014 Participants3047 Participants
Negative
65.0365.2266.17196.42
Positive
34.9734.7833.83103.58
 
[1]Measure Description: Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.
Tumor size [1]
Measure Type: Number
Unit of measure: percent of participants
Number Analyzed1018 Participants1015 Participants1014 Participants3047 Participants
Unknown
2.652.462.077.18
<=2 cm
66.4064.6366.86197.89
>2cm
30.9432.9131.0794.92
 
[1]Measure Description: Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.
Tumor grade [1]
Measure Type: Number
Unit of measure: percent of participants
Number Analyzed1018 Participants1015 Participants1014 Participants3047 Participants
Unknown
2.362.362.176.89
1
27.0126.1124.3677.48
2
48.3350.6453.65152.62
3
22.3020.8919.8263.01
 
[1]Measure Description: 

Tumor grade is the histologic grade according to the BRE method. The method involves assessment of tumor morphology, including tubule formation, nuclear pleomorphism and frequency of mitoses. Grades are recorded according to criteria as 1,2 or 3. Grade 3 is associated with poor prognosis.

Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.

HER2-status [1]
Measure Type: Number
Unit of measure: percent of participants
Number Analyzed1018 Participants1015 Participants1014 Participants3047 Participants
Unknown
4.322.862.669.84
Negative
84.1885.4284.52254.12
Positive
11.4911.7212.8236.03
 
[1]Measure Description: Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.
Open or close this module Outcome Measures
1. Primary Outcome:
Title Disease-free Survival
Description Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to the first appearance of one of the following: invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow-up.
Time Frame 5-year estimates, reported at a median follow-up of 67 months.
Outcome Measure Data
Analysis Population Description
Intention-to-treat
 
Arm/Group TitleTamoxifenT+OFSE+OFS
Arm/Group DescriptionTamoxifen 20mg orally daily for 5 yearsTamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
Overall Number of Participants Analyzed1018 1015 1014
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
84.7(82.2 to 86.9) 86.6(84.2 to 88.7) 89(86.8 to 90.9)
Statistical Analysis 1
Statistical Analysis OverviewComparison Group SelectionTamoxifen, T+OFS
Comments[Not specified]
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.1
Comments[Not specified]
MethodLog Rank
Comments[Not specified]
Method of EstimationEstimation ParameterHazard Ratio (HR)
Estimated Value0.83
Confidence Interval(2-sided) 95%
0.66 to 1.04
Estimation CommentsTamoxifen was the reference group in the estimation of the hazard ratio.
Statistical Analysis 2
Statistical Analysis OverviewComparison Group SelectionTamoxifen, E+OFS
Comments[Not specified]
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterHazard Ratio (HR)
Estimated Value0.68
Confidence Interval(2-sided) 95%
0.53 to 0.86
Estimation CommentsTamoxifen was the reference group in the estimation of the hazard ratio.
2. Secondary Outcome:
Title Breast Cancer-free Interval
Description Estimated percentage of patients alive and disease-free at 5 years from randomization, where breast cancer-free interval is defined as the time from randomization to invasive breast cancer recurrence at local, regional, or distant site, or invasive contralateral breast cancer; or censored at date of last follow up.
Time Frame 5-year estimates, reported at a median follow-up of 67 months.
Outcome Measure Data
Analysis Population Description
Intention-to-treat
 
Arm/Group TitleTamoxifenT+OFSE+OFS
Arm/Group DescriptionTamoxifen 20mg orally daily for 5 yearsTamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
Overall Number of Participants Analyzed1018 1015 1014
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
86.4(84.0 to 88.5) 88.4(86.1 to 90.3) 90.9(88.9 to 92.6)
Statistical Analysis 1
Statistical Analysis OverviewComparison Group SelectionTamoxifen, T+OFS
Comments[Not specified]
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.09
Comments[Not specified]
MethodLog Rank
Comments[Not specified]
Method of EstimationEstimation ParameterHazard Ratio (HR)
Estimated Value0.81
Confidence Interval(2-sided) 95%
0.3 to 1.03
Estimation CommentsTamoxifen was the reference group in the estimation of the hazard ratio.
Statistical Analysis 2
Statistical Analysis OverviewComparison Group SelectionTamoxifen, E+OFS
Comments[Not specified]
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterHazard Ratio (HR)
Estimated Value0.64
Confidence Interval(2-sided) 95%
0.49 to 0.83
Estimation CommentsTamoxifen was the reference group in the estimation of the hazard ratio.
3. Secondary Outcome:
Title Distant Recurrence-free Interval
Description Estimated percentage of patients alive and disease-free at 5 years from randomization, where distant recurrence-free Interval is defined as the time from randomization to invasive breast cancer recurrence at distant site, or invasive contralateral breast cancer; or censored at date of last follow up.
Time Frame 5-year estimates, reported at a median follow-up of 67 months.
Outcome Measure Data
Analysis Population Description
Intention-to-treat
 
Arm/Group TitleTamoxifenT+OFSE+OFS
Arm/Group DescriptionTamoxifen 20mg orally daily for 5 yearsTamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
Overall Number of Participants Analyzed1018 1015 1014
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
90.7(88.6 to 92.4) 91.3(89.2 to 92.9) 93.0(91.2 to 94.5)
Statistical Analysis 1
Statistical Analysis OverviewComparison Group SelectionTamoxifen, T+OFS
Comments[Not specified]
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.40
Comments[Not specified]
MethodLog Rank
Comments[Not specified]
Method of EstimationEstimation ParameterHazard Ratio (HR)
Estimated Value0.88
Confidence Interval(2-sided) 95%
0.66 to 1.18
Estimation CommentsT was the reference group in the estimation of the hazard ratio.
Statistical Analysis 2
Statistical Analysis OverviewComparison Group SelectionTamoxifen, E+OFS
Comments[Not specified]
Type of Statistical TestSuperiority
Comments[Not specified]
Method of EstimationEstimation ParameterHazard Ratio (HR)
Estimated Value0.71
Confidence Interval(2-sided) 95%
0.52 to 0.96
Estimation CommentsT was the reference group in the estimation of hazard ratio.
4. Secondary Outcome:
Title Overall Survival
Description Estimated percentage of patients alive at 8 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive.
Time Frame 8-year estimates, reported at a median follow-up of 8 years
Outcome Measure Data
Analysis Population Description
Intention-to-treat
 
Arm/Group TitleTamoxifenT+OFSE+OFS
Arm/Group Description

Tamoxifen 20mg orally daily for 5 years

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies

Tamoxifen: Tamoxifen 20mg orally daily for 5 years

Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)

Laboratory Biomarker Analysis: Correlative studies

Oophorectomy: Undergo bilateral surgical oophorectomy

Quality-of-Life Assessment: Ancillary studies

Radiation Therapy: Undergo ovarian irradiation

Tamoxifen: Tamoxifen 20mg orally daily for 5 years

Triptorelin: 3.75 mg by im injection q28 days for 5 years

Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)

Exemestane: Exemestane 25mg orally daily for 5 years plus ovarian function suppression

Laboratory Biomarker Analysis: Correlative studies

Oophorectomy: Undergo bilateral surgical oophorectomy

Quality-of-Life Assessment: Ancillary studies

Radiation Therapy: Undergo ovarian irradiation

Triptorelin: 3.75 mg by im injection q28 days for 5 years

Overall Number of Participants Analyzed1018 1015 1014
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
91.5(89.4 to 93.2) 93.3(91.4 to 94.8) 92.1(90.0 to 93.7)
Statistical Analysis 1
Statistical Analysis OverviewComparison Group SelectionTamoxifen, T+OFS
Comments[Not specified]
Type of Statistical TestSuperiority
Comments[not specified]
Statistical Test of HypothesisP-Value0.01
Comments[Not specified]
MethodLog Rank
Comments[Not specified]
Method of EstimationEstimation ParameterHazard Ratio (HR)
Estimated Value0.67
Confidence Interval(2-sided) 95%
0.48 to 0.92
Estimation CommentsT was the reference group in the estimation of the hazard ratio
Statistical Analysis 2
Statistical Analysis OverviewComparison Group SelectionTamoxifen, E+OFS
Comments[Not specified]
Type of Statistical TestSuperiority
Comments[not specified]
Method of EstimationEstimation ParameterHazard Ratio (HR)
Estimated Value0.85
Confidence Interval(2-sided) 95%
0.62 to 1.15
Estimation CommentsT was the reference group in the estimation of hazard ratio
Open or close this module Adverse Events
 
Time Frame Assessed every 3 months for the first year, then every 6 month until year 6. Reported at a median follow-up of 67 months.
Adverse Event Reporting Description Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution. The safety population EXCLUDES patients who never started protocol-assigned therapy.
 
Arm/Group Title Tamoxifen T+OFS E+OFS
Arm/Group Description Tamoxifen 20mg orally daily for 5 years Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation) Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
All-Cause Mortality
  TamoxifenT+OFSE+OFS
 Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)
Total 87 / 1007 (8.64%)68 / 1007 (6.75%)80 / 1001 (7.99%)
Serious Adverse Events
  TamoxifenT+OFSE+OFS
 Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)
Total 315 / 1007 (31.28%)375 / 1007 (37.24%)375 / 1001 (37.46%)
Blood and lymphatic system disorders
Hemoglobin † A 2 / 1007 (0.2%)2 / 1007 (0.2%)2 / 1001 (0.2%)
Cardiac disorders
Cardiac Arrhythmia-Other (Specify) † A 0 / 1007 (0%)1 / 1007 (0.1%)0 / 1001 (0%)
Cardiac-ischemia/infarction † A 4 / 1007 (0.4%)1 / 1007 (0.1%)3 / 1001 (0.3%)
Conduction abnormality/Atrioventricular heart block - AV block-third degree (complete AV block) † A 0 / 1007 (0%)0 / 1007 (0%)1 / 1001 (0.1%)
Conduction abnormality/Atrioventricular heart block - Sick sinus syndrome † A 0 / 1007 (0%)0 / 1007 (0%)1 / 1001 (0.1%)
Left ventricular diastolic dysfunction † A 0 / 1007 (0%)0 / 1007 (0%)1 / 1001 (0.1%)
Left ventricular systolic dysfunction † A 0 / 1007 (0%)2 / 1007 (0.2%)3 / 1001 (0.3%)
Pain - Cardiac/heart † A 0 / 1007 (0%)0 / 1007 (0%)1 / 1001 (0.1%)
Restrictive cardiomyopathy † A 0 / 1007 (0%)0 / 1007 (0%)1 / 1001 (0.1%)
Right ventricular dysfunction (cor pulmonale) † A 0 / 1007 (0%)0 / 1007 (0%)1 / 1001 (0.1%)
Supraventricular and nodal arrhythmia - Atrial fibrillation † A 0 / 1007 (0%)0 / 1007 (0%)1 / 1001 (0.1%)
Supraventricular and nodal arrhythmia - Sinus arrhythmia † A 0 / 1007 (0%)1 / 1007 (0.1%)0 / 1001 (0%)
Supraventricular and nodal arrhythmia - Supraventricular tachycardia † A 0 / 1007 (0%)1 / 1007 (0.1%)0 / 1001 (0%)
Valvular heart disease † A 2 / 1007 (0.2%)0 / 1007 (0%)0 / 1001 (0%)
Ear and labyrinth disorders
Auditory/Ear-Other (Specify) † A 1 / 1007 (0.1%)0 / 1007 (0%)0 / 1001 (0%)
Hearing: patients without baseline audiogram and not enrolled in a monitoring program † A 1 / 1007 (0.1%)0 / 1007 (0%)1 / 1001 (0.1%)
Endocrine disorders
Adrenal insufficiency † A 0 / 1007 (0%)1 / 1007 (0.1%)0 / 1001 (0%)
Endocrine-Other (Specify) † A 1 / 1007 (0.1%)0 / 1007 (0%)0 / 1001 (0%)
Thyroid function, high (hyperthyroidism, thyrotoxicosis) † A 0 / 1007 (0%)1 / 1007 (0.1%)1 / 1001 (0.1%)
Thyroid function, low (hypothyroidism) † A 0 / 1007 (0%)0 / 1007 (0%)1 / 1001 (0.1%)
Eye disorders
Cataract † A 1 / 1007 (0.1%)0 / 1007 (0%)1 / 1001 (0.1%)
Ocular/Visual-Other (Specify) † A 1 / 1007 (0.1%)0 / 1007 (0%)0 / 1001 (0%)
Optic disc edema † A 0 / 1007 (0%)0 / 1007 (0%)1 / 1001 (0.1%)
Retinal detachment † A 3 / 1007 (0.3%)1 / 1007 (0.1%)1 / 1001 (0.1%)
Vision-flashing lights/floaters † A 0 / 1007 (0%)0 / 1007 (0%)1 / 1001 (0.1%)
Gastrointestinal disorders
Colitis † A 2 / 1007 (0.2%)1 / 1007 (0.1%)1 / 1001 (0.1%)
Constipation † A 0 / 1007 (0%)1 / 1007 (0.1%)0 / 1001 (0%)
Diarrhea † A 1 / 1007 (0.1%)2 / 1007 (0.2%)1 / 1001 (0.1%)
Distention/bloating, abdominal † A 0 / 1007 (0%)1 / 1007 (0.1%)0 / 1001 (0%)
Dysphagia (difficulty swallowing) † A 0 / 1007 (0%)1 / 1007 (0.1%)0 / 1001 (0%)
Gastrointestinal-Other (Specify) † A 2 / 1007 (0.2%)1 / 1007 (0.1%)2 / 1001 (0.2%)
Heartburn/dyspepsia † A 0 / 1007 (0%)1 / 1007 (0.1%)1 / 1001 (0.1%)
Hemorrhoids † A 0 / 1007 (0%)1 / 1007 (0.1%)1 / 1001 (0.1%)
Mucositis/stomatitis (functional/symptomatic) - Oral cavity † A 0 / 1007 (0%)1 / 1007 (0.1%)0 / 1001 (0%)
Nausea † A 0 / 1007 (0%)4 / 1007 (0.4%)2 / 1001 (0.2%)
Necrosis, GI - Ileum † A 0 / 1007 (0%)1 / 1007 (0.1%)0 / 1001 (0%)
Obstruction, GI - Small bowel NOS † A 1 / 1007 (0.1%)0 / 1007 (0%)0 / 1001 (0%)
Pain - Abdomen NOS † A 3 / 1007 (0.3%)3 / 1007 (0.3%)4 / 1001 (0.4%)
Pain - Rectum † A 0 / 1007 (0%)1 / 1007 (0.1%)0 / 1001 (0%)
Pancreatitis † A 0 / 1007 (0%)1 / 1007 (0.1%)1 / 1001 (0.1%)
Stricture/stenosis (including anastomotic), GI - Small bowel NOS † A 0 / 1007 (0%)0 / 1007 (0%)1 / 1001 (0.1%)
Ulcer, GI - Anus † A 1 / 1007 (0.1%)0 / 1007 (0%)0 / 1001 (0%)
Vomiting † A 0 / 1007 (0%)1 / 1007 (0.1%)1 / 1001 (0.1%)
General disorders
Death not associated with CTCAE term - Death NOS † A 1 / 1007 (0.1%)0 / 1007 (0%)0 / 1001 (0%)
Death not associated with CTCAE term - Sudden death † A 0 / 1007 (0%)0 / 1007 (0%)1 / 1001 (0.1%)
Edema: limb † A 2 / 1007 (0.2%)0 / 1007 (0%)0 / 1001 (0%)
Fatigue (asthenia, lethargy, malaise) † A 32 / 1007 (3.18%)36 / 1007 (3.57%)33 / 1001 (3.3%)
Flu-like syndrome † A 0 / 1007 (0%)1 / 1007 (0.1%)0 / 1001 (0%)
Injection site reaction/extravasation changes † A 0 / 1007 (0%)0 / 1007 (0%)1 / 1001 (0.1%)
Pain - Chest/thorax NOS † A 2 / 1007 (0.2%)1 / 1007 (0.1%)2 / 1001 (0.2%)
Pain-Other (Specify) † A 1 / 1007 (0.1%)0 / 1007 (0%)1 / 1001 (0.1%)
Hepatobiliary disorders
Cholecystitis † A 2 / 1007 (0.2%)2 / 1007 (0.2%)2 / 1001 (0.2%)
Hepatobiliary/Pancreas-Other (Specify) † A 3 / 1007 (0.3%)2 / 1007 (0.2%)4 / 1001 (0.4%)
Liver dysfunction/failure (clinical) † A 1 / 1007 (0.1%)5 / 1007 (0.5%)1 / 1001 (0.1%)
Pain - Gallbladder † A 0 / 1007 (0%)1 / 1007 (0.1%)0 / 1001 (0%)
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever) † A 1 / 1007 (0.1%)2 / 1007 (0.2%)6 / 1001 (0.6%)
Allergy/Immunology-Other (Specify) † A 0 / 1007 (0%)2 / 1007 (0.2%)0 / 1001 (0%)
Infections and infestations
Infection (documented clinically or microbiologically) w/Grade 3 or 4 neutrophils -Skin (cellulitis) † A 0 / 1007 (0%)1 / 1007 (0.1%)0 / 1001 (0%)
Infection (documented clinically or microbiologically) w/Grade 3 or 4 neutrophils -Urinary tract NOS † A 1 / 1007 (0.1%)0 / 1007 (0%)0 / 1001 (0%)
Infection (documented clinically/microbiologically) w/Grade 3/4 neutrophils -Gallbladder † A 1 / 1007 (0.1%)0 / 1007 (0%)0 / 1001 (0%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Abdomen NOS † A 0 / 1007 (0%)0 / 1007 (0%)1 / 1001 (0.1%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Appendix † A 1 / 1007 (0.1%)2 / 1007 (0.2%)1 / 1001 (0.1%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Bladder (urinary) † A 1 / 1007 (0.1%)1 / 1007 (0.1%)1 / 1001 (0.1%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Foreign body (e.g., graft, implant) † A 1 / 1007 (0.1%)2 / 1007 (0.2%)1 / 1001 (0.1%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Kidney † A 0 / 1007 (0%)1 / 1007 (0.1%)1 / 1001 (0.1%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia) † A 2 / 1007 (0.2%)3 / 1007 (0.3%)0 / 1001 (0%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Pelvis NOS † A 0 / 1007 (0%)0 / 1007 (0%)1 / 1001 (0.1%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis) † A 4 / 1007 (0.4%)10 / 1007 (0.99%)12 / 1001 (1.2%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Soft tissue NOS † A 0 / 1007 (0%)1 / 1007 (0.1%)0 / 1001 (0%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS † A 0 / 1007 (0%)1 / 1007 (0.1%)2 / 1001 (0.2%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Vagina † A 1 / 1007 (0.1%)0 / 1007 (0%)0 / 1001 (0%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Wound † A 3 / 1007 (0.3%)3 / 1007 (0.3%)1 / 1001 (0.1%)
Infection with unknown ANC - Heart (endocarditis) † A 1 / 1007 (0.1%)0 / 1007 (0%)0 / 1001 (0%)
Infection with unknown ANC - Rectum † A 0 / 1007 (0%)1 / 1007 (0.1%)0 / 1001 (0%)
Infection with unknown ANC - Skin (cellulitis) † A 3 / 1007 (0.3%)2 / 1007 (0.2%)1 / 1001 (0.1%)
Infection with unknown ANC - Wound † A 0 / 1007 (0%)0 / 1007 (0%)1 / 1001 (0.1%)
Infection-Other (Specify) † A 0 / 1007 (0%)1 / 1007 (0.1%)2 / 1001 (0.2%)
Injury, poisoning and procedural complications
Fracture † A 8 / 1007 (0.79%)8 / 1007 (0.79%)12 / 1001 (1.2%)
Hemorrhage/bleeding associated with surgery, intra-operative or post-operative † A 0 / 1007 (0%)0 / 1007 (0%)1 / 1001 (0.1%)
Intra-operative injury - Vein NOS † A 1 / 1007 (0.1%)0 / 1007 (0%)0 / 1001 (0%)
Rash: dermatitis associated with radiation - Radiation † A 2 / 1007 (0.2%)0 / 1007 (0%)1 / 1001 (0.1%)
Thrombosis/embolism (vascular access-related) † A 17 / 1007 (1.69%)17 / 1007 (1.69%)7 / 1001 (0.7%)
Wound complication, non-infectious † A 0 / 1007 (0%)1 / 1007 (0.1%)1 / 1001 (0.1%)
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase) † A 1 / 1007 (0.1%)3 / 1007 (0.3%)2 / 1001 (0.2%)
AST, SGOT (serum glutamic oxaloacetic transaminase) † A 1 / 1007 (0.1%)1 / 1007 (0.1%)0 / 1001 (0%)
Creatinine † A 0 / 1007 (0%)1 / 1007 (0.1%)0 / 1001 (0%)
GGT (gamma-glutamyl transpeptidase) † A 2 / 1007 (0.2%)3 / 1007 (0.3%)5 / 1001 (0.5%)
Leukocytes (total WBC) † A 0 / 1007 (0%)1 / 1007 (0.1%)0 / 1001 (0%)
Weight loss † A 0 / 1007 (0%)2 / 1007 (0.2%)2 / 1001 (0.2%)
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia) † A 1 / 1007 (0.1%)9 / 1007 (0.89%)5 / 1001 (0.5%)
Iron overload † A 0 / 1007 (0%)1 / 1007 (0.1%)0 / 1001 (0%)
Pancreatic endocrine: glucose intolerance † A 3 / 1007 (0.3%)14 / 1007 (1.39%)3 / 1001 (0.3%)
Potassium, serum-low (hypokalemia) † A 2 / 1007 (0.2%)2 / 1007 (0.2%)0 / 1001 (0%)
Musculoskeletal and connective tissue disorders
Arthritis (non-septic) † A 1 / 1007 (0.1%)0 / 1007 (0%)0 / 1001 (0%)
Lumbar spine-range of motion † A 0 / 1007 (0%)1 / 1007 (0.1%)0 / 1001 (0%)
Musculoskeletal/Soft Tissue-Other (Specify) † A 2 / 1007 (0.2%)1 / 1007 (0.1%)3 / 1001 (0.3%)
Myositis (inflammation/damage of muscle) † A 0 / 1007 (0%)1 / 1007 (0.1%)0 / 1001 (0%)
Osteoporosis † A 1 / 1007 (0.1%)3 / 1007 (0.3%)2 / 1001 (0.2%)
Pain - Back † A 1 / 1007 (0.1%)1 / 1007 (0.1%)1 / 1001 (0.1%)
Pain - Chest wall † A 1 / 1007 (0.1%)0 / 1007 (0%)1 / 1001 (0.1%)
Pain - Extremity-limb † A 0 / 1007 (0%)1 / 1007 (0.1%)0 / 1001 (0%)
Pain - Joint † A 64 / 1007 (6.36%)55 / 1007 (5.46%)119 / 1001 (11.89%)
Pain - Muscle † A 1 / 1007 (0.1%)0 / 1007 (0%)0 / 1001 (0%)
Nervous system disorders
CNS cerebrovascular ischemia † A 4 / 1007 (0.4%)1 / 1007 (0.1%)3 / 1001 (0.3%)
Cognitive disturbance † A 1 / 1007 (0.1%)1 / 1007 (0.1%)1 / 1001 (0.1%)
Dizziness † A 3 / 1007 (0.3%)0 / 1007 (0%)5 / 1001 (0.5%)
Hemorrhage, CNS † A 0 / 1007 (0%)1 / 1007 (0.1%)0 / 1001 (0%)
Memory impairment † A 0 / 1007 (0%)0 / 1007 (0%)1 / 1001 (0.1%)
Myelitis † A 0 / 1007 (0%)0 / 1007 (0%)1 / 1001 (0.1%)
Neurology-Other (Specify) † A 2 / 1007 (0.2%)1 / 1007 (0.1%)2 / 1001 (0.2%)
Neuropathy: cranial - CN V Motor-jaw muscles; Sensory-facial † A 1 / 1007 (0.1%)0 / 1007 (0%)0 / 1001 (0%)
Neuropathy: cranial - CN VIII Hearing and balance † A 0 / 1007 (0%)1 / 1007 (0.1%)1 / 1001 (0.1%)
Neuropathy: sensory † A 1 / 1007 (0.1%)5 / 1007 (0.5%)4 / 1001 (0.4%)
Pain - Head/headache † A 6 / 1007 (0.6%)10 / 1007 (0.99%)10 / 1001 (1%)
Pain - Neuralgia/peripheral nerve † A 0 / 1007 (0%)2 / 1007 (0.2%)6 / 1001 (0.6%)
Syncope (fainting) † A 1 / 1007 (0.1%)2 / 1007 (0.2%)4 / 1001 (0.4%)
Vasovagal episode † A 0 / 1007 (0%)0 / 1007 (0%)1 / 1001 (0.1%)
Psychiatric disorders
Insomnia † A 29 / 1007 (2.88%)46 / 1007 (4.57%)45 / 1001 (4.5%)
Mood alteration - anxiety † A 2 / 1007 (0.2%)2 / 1007 (0.2%)1 / 1001 (0.1%)
Mood alteration - depression † A 38 / 1007 (3.77%)44 / 1007 (4.37%)37 / 1001 (3.7%)
Psychosis (hallucinations/delusions) † A 0 / 1007 (0%)0 / 1007 (0%)1 / 1001 (0.1%)
Renal and urinary disorders
Incontinence, urinary † A 6 / 1007 (0.6%)5 / 1007 (0.5%)4 / 1001 (0.4%)
Obstruction, GU - Ureter † A 0 / 1007 (0%)1 / 1007 (0.1%)4 / 1001 (0.4%)
Renal failure † A 1 / 1007 (0.1%)0 / 1007 (0%)0 / 1001 (0%)
Renal/Genitourinary-Other (Specify) † A 49 / 1007 (4.87%)19 / 1007 (1.89%)11 / 1001 (1.1%)
Stricture/stenosis (including anastomotic), GU - Ureter † A 0 / 1007 (0%)0 / 1007 (0%)1 / 1001 (0.1%)
Reproductive system and breast disorders
Hemorrhage, GU - Ovary † A 1 / 1007 (0.1%)0 / 1007 (0%)0 / 1001 (0%)
Hemorrhage, GU - Uterus † A 5 / 1007 (0.5%)1 / 1007 (0.1%)3 / 1001 (0.3%)
Hemorrhage, GU - Vagina † A 5 / 1007 (0.5%)1 / 1007 (0.1%)1 / 1001 (0.1%)
Irregular menses (change from baseline) † A 4 / 1007 (0.4%)2 / 1007 (0.2%)0 / 1001 (0%)
Pain - Breast † A 2 / 1007 (0.2%)0 / 1007 (0%)1 / 1001 (0.1%)
Pain - Ovulatory † A 1 / 1007 (0.1%)1 / 1007 (0.1%)0 / 1001 (0%)
Pain - Pelvis † A 1 / 1007 (0.1%)0 / 1007 (0%)0 / 1001 (0%)
Pain - Vagina † A 14 / 1007 (1.39%)22 / 1007 (2.18%)19 / 1001 (1.9%)
Sexual/Reproductive Function-Other (Specify) † A 0 / 1007 (0%)2 / 1007 (0.2%)2 / 1001 (0.2%)
Stricture/stenosis (including anastomotic), GU - Uterus † A 1 / 1007 (0.1%)0 / 1007 (0%)0 / 1001 (0%)
Respiratory, thoracic and mediastinal disorders
Apnea † A 1 / 1007 (0.1%)0 / 1007 (0%)2 / 1001 (0.2%)
Dyspnea (shortness of breath) † A 2 / 1007 (0.2%)2 / 1007 (0.2%)2 / 1001 (0.2%)
Hypoxia † A 1 / 1007 (0.1%)1 / 1007 (0.1%)0 / 1001 (0%)
Obstruction/stenosis of airway - Bronchus † A 0 / 1007 (0%)0 / 1007 (0%)1 / 1001 (0.1%)
Pain - Pleura † A 0 / 1007 (0%)1 / 1007 (0.1%)0 / 1001 (0%)
Pleural effusion (non-malignant) † A 0 / 1007 (0%)1 / 1007 (0.1%)0 / 1001 (0%)
Pneumonitis/pulmonary infiltrates † A 0 / 1007 (0%)1 / 1007 (0.1%)0 / 1001 (0%)
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis) † A 0 / 1007 (0%)0 / 1007 (0%)1 / 1001 (0.1%)
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other (Specify) † A 2 / 1007 (0.2%)1 / 1007 (0.1%)0 / 1001 (0%)
Pain - Skin † A 0 / 1007 (0%)1 / 1007 (0.1%)0 / 1001 (0%)
Pruritus/itching † A 0 / 1007 (0%)3 / 1007 (0.3%)0 / 1001 (0%)
Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis) † A 0 / 1007 (0%)0 / 1007 (0%)1 / 1001 (0.1%)
Soft tissue necrosis - Thorax † A 0 / 1007 (0%)1 / 1007 (0.1%)0 / 1001 (0%)
Vascular disorders
Hematoma † A 1 / 1007 (0.1%)0 / 1007 (0%)0 / 1001 (0%)
Hot flashes/flushes † A 76 / 1007 (7.55%)133 / 1007 (13.21%)107 / 1001 (10.69%)
Hypertension † A 54 / 1007 (5.36%)75 / 1007 (7.45%)68 / 1001 (6.79%)
Thrombosis/thrombus/embolism † A 0 / 1007 (0%)2 / 1007 (0.2%)0 / 1001 (0%)
Vascular-Other (Specify) † A 1 / 1007 (0.1%)0 / 1007 (0%)0 / 1001 (0%)
†Indicates events were collected by systematic assessment.
ATerm from vocabulary, CTCAE (3.0)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
  TamoxifenT+OFSE+OFS
 Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)
Total 951 / 1007 (94.44%)982 / 1007 (97.52%)980 / 1001 (97.9%)
Cardiac disorders
Cardiac-ischemia/infarction † A 1 / 1007 (0.1%)2 / 1007 (0.2%)5 / 1001 (0.5%)
Gastrointestinal disorders
Nausea † A 239 / 1007 (23.73%)215 / 1007 (21.35%)228 / 1001 (22.78%)
General disorders
Fatigue (asthenia, lethargy, malaise) † A 571 / 1007 (56.7%)595 / 1007 (59.09%)591 / 1001 (59.04%)
Injection site reaction/extravasation changes † A 4 / 1007 (0.4%)88 / 1007 (8.74%)84 / 1001 (8.39%)
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever) † A 31 / 1007 (3.08%)42 / 1007 (4.17%)46 / 1001 (4.6%)
Injury, poisoning and procedural complications
Fracture † A 41 / 1007 (4.07%)46 / 1007 (4.57%)51 / 1001 (5.09%)
Thrombosis/embolism (vascular access-related) † A 5 / 1007 (0.5%)3 / 1007 (0.3%)2 / 1001 (0.2%)
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia) † A 15 / 1007 (1.49%)37 / 1007 (3.67%)17 / 1001 (1.7%)
Pancreatic endocrine: glucose intolerance † A 15 / 1007 (1.49%)21 / 1007 (2.09%)28 / 1001 (2.8%)
Musculoskeletal and connective tissue disorders
Osteoporosis † A 123 / 1007 (12.21%)198 / 1007 (19.66%)316 / 1001 (31.57%)
Pain - Joint † A 631 / 1007 (62.66%)700 / 1007 (69.51%)778 / 1001 (77.72%)
Nervous system disorders
CNS cerebrovascular ischemia † A 2 / 1007 (0.2%)1 / 1007 (0.1%)0 / 1001 (0%)
Hemorrhage, CNS † A 14 / 1007 (1.39%)9 / 1007 (0.89%)8 / 1001 (0.8%)
Psychiatric disorders
Insomnia † A 437 / 1007 (43.4%)529 / 1007 (52.53%)549 / 1001 (54.85%)
Libido † A 427 / 1007 (42.4%)477 / 1007 (47.37%)492 / 1001 (49.15%)
Mood alteration - depression † A 431 / 1007 (42.8%)478 / 1007 (47.47%)476 / 1001 (47.55%)
Renal and urinary disorders
Incontinence, urinary † A 156 / 1007 (15.49%)180 / 1007 (17.87%)120 / 1001 (11.99%)
Reproductive system and breast disorders
Pain - Vagina † A 224 / 1007 (22.24%)240 / 1007 (23.83%)290 / 1001 (28.97%)
Vaginal dryness † A 421 / 1007 (41.81%)500 / 1007 (49.65%)541 / 1001 (54.05%)
Skin and subcutaneous tissue disorders
Sweating (diaphoresis) † A 486 / 1007 (48.26%)621 / 1007 (61.67%)566 / 1001 (56.54%)
Vascular disorders
Hot flashes/flushes † A 727 / 1007 (72.19%)806 / 1007 (80.04%)820 / 1001 (81.92%)
Hypertension † A 119 / 1007 (11.82%)158 / 1007 (15.69%)165 / 1001 (16.48%)
†Indicates events were collected by systematic assessment.
ATerm from vocabulary, CTCAE (3.0)
Open or close this module Limitations and Caveats
[Not specified]
Open or close this module More Information
Certain Agreements:
Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact:
Name/Official Title:
 Dr. Heidi Roschitzki-Voser, Head Trial Activities/Deputy Director
Organization:
 ETOP IBCSG Partners Foundation
Phone:
 +41 31 511 94 00
Email:
 heidi.roschitzki@etop.ibcsg.org
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services