ClinicalTrials.gov
History of Changes for Study: NCT00066703
Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer (TEXT)
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 January 10, 2006 Contacts/Locations and Study Status
23 January 12, 2006 Contacts/Locations, Study Status, Eligibility and Study Description
24 January 16, 2006 Contacts/Locations and Study Status
25 January 24, 2006 Contacts/Locations and Study Status
26 February 6, 2006 Contacts/Locations and Study Status
27 February 9, 2006 Study Status and Contacts/Locations
28 March 8, 2006 Contacts/Locations and Study Status
29 March 9, 2006 Contacts/Locations and Study Status
30 March 15, 2006 Contacts/Locations and Study Status
31 March 21, 2006 Study Status and Study Identification
32 March 29, 2006 Contacts/Locations and Study Status
33 April 11, 2006 Study Status, Contacts/Locations and Eligibility
34 April 19, 2006 Contacts/Locations and Study Status
35 April 24, 2006 Contacts/Locations, Arms and Interventions and Study Status
36 May 10, 2006 Contacts/Locations and Study Status
37 May 16, 2006 Contacts/Locations and Study Status
38 May 30, 2006 Contacts/Locations and Study Status
39 June 7, 2006 Study Status
40 June 8, 2006 Contacts/Locations and Study Status
41 June 13, 2006 Contacts/Locations and Study Status
42 June 22, 2006 Contacts/Locations and Study Status
43 June 28, 2006 Contacts/Locations and Study Status
44 July 5, 2006 Contacts/Locations and Study Status
45 July 13, 2006 Contacts/Locations and Study Status
46 July 19, 2006 Contacts/Locations and Study Status
47 July 26, 2006 Contacts/Locations and Study Status
48 August 3, 2006 Study Status
49 August 10, 2006 Contacts/Locations and Study Status
50 August 16, 2006 Contacts/Locations and Study Status
51 August 24, 2006 Contacts/Locations and Study Status
52 August 29, 2006 Contacts/Locations and Study Status
53 September 6, 2006 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 September 29, 2006 Study Status
58 October 12, 2006 Contacts/Locations and Study Status
59 October 18, 2006 Contacts/Locations and Study Status
60 October 25, 2006 Contacts/Locations, Eligibility and Study Status
61 November 8, 2006 Study Design, Conditions, Study Status, References and Study Identification
62 November 9, 2006 Contacts/Locations and Study Status
63 November 16, 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 20, 2006 Contacts/Locations and Study Status
67 December 27, 2006 Contacts/Locations, Outcome Measures and Study Status
68 January 11, 2007 Study Status
69 January 16, 2007 Contacts/Locations and Study Status
70 January 25, 2007 Contacts/Locations, Study Status and Eligibility
71 January 30, 2007 Contacts/Locations and Study Status
72 February 8, 2007 Contacts/Locations and Study Status
73 February 20, 2007 Contacts/Locations, Study Status and Eligibility
74 March 5, 2007 Contacts/Locations and Study Status
75 March 7, 2007 Contacts/Locations and Study Status
76 March 13, 2007 Contacts/Locations and Study Status
77 March 20, 2007 Contacts/Locations and Study Status
78 March 27, 2007 Contacts/Locations and Study Status
79 April 9, 2007 Contacts/Locations and Study Status
80 April 11, 2007 Contacts/Locations and Study Status
81 April 18, 2007 Contacts/Locations and Study Status
82 April 25, 2007 Contacts/Locations and Study Status
83 May 2, 2007 Contacts/Locations and Study Status
84 May 3, 2007 Study Status and Contacts/Locations
85 May 8, 2007 Contacts/Locations and Study Status
86 May 16, 2007 Contacts/Locations and Study Status
87 May 23, 2007 Contacts/Locations and Study Status
88 June 4, 2007 Contacts/Locations and Study Status
89 June 6, 2007 Contacts/Locations and Study Status
90 June 13, 2007 Contacts/Locations and Study Status
91 June 20, 2007 Contacts/Locations and Study Status
92 June 25, 2007 Contacts/Locations and Study Status
93 July 3, 2007 Contacts/Locations and Study Status
94 July 10, 2007 Contacts/Locations and Study Status
95 July 17, 2007 Contacts/Locations and Study Status
96 July 30, 2007 Contacts/Locations and Study Status
97 August 8, 2007 Contacts/Locations and Study Status
98 August 21, 2007 Contacts/Locations and Study Status
99 August 24, 2007 Contacts/Locations and Study Status
100 August 28, 2007 Contacts/Locations and Study Status
101 September 5, 2007 Study Status and Contacts/Locations
102 September 10, 2007 Contacts/Locations and Study Status
103 September 18, 2007 Contacts/Locations and Study Status
104 September 20, 2007 Contacts/Locations and Study Status
105 September 25, 2007 Contacts/Locations and Study Status
106 September 27, 2007 Contacts/Locations and Study Status
107 October 1, 2007 Contacts/Locations and Study Status
108 October 5, 2007 Contacts/Locations and Study Status
109 October 13, 2007 Contacts/Locations and Study Status
110 October 17, 2007 Contacts/Locations and Study Status
111 October 19, 2007 Contacts/Locations and Study Status
112 October 25, 2007 Contacts/Locations, Arms and Interventions and Study Status
113 October 30, 2007 Contacts/Locations and Study Status
114 November 9, 2007 Study Status and Contacts/Locations
115 November 14, 2007 Contacts/Locations and Study Status
116 November 15, 2007 Contacts/Locations and Study Status
117 November 16, 2007 Contacts/Locations and Study Status
118 November 21, 2007 Contacts/Locations and Study Status
119 November 22, 2007 Contacts/Locations and Study Status
120 November 27, 2007 Contacts/Locations and Study Status
121 November 30, 2007 Contacts/Locations and Study Status
122 December 1, 2007 Contacts/Locations and Study Status
123 December 4, 2007 Recruitment Status, Study Status and Contacts/Locations
124 December 15, 2007 Arms and Interventions and Study Status
125 December 25, 2007 Study Status
126 April 30, 2008 Study Description and Study Status
127 May 23, 2008 Arms and Interventions and Study Status
128 July 23, 2008 Study Design and Study Status
129 August 12, 2008 Study Design, Study Description and Study Status
130 September 10, 2008 Recruitment Status, Study Status and Contacts/Locations
131 September 18, 2008 Recruitment Status, Study Status and Contacts/Locations
132 October 22, 2008 Study Status
133 November 20, 2008 Study Status and Contacts/Locations
134 November 25, 2008 Contacts/Locations and Study Status
135 November 28, 2008 Contacts/Locations and Study Status
136 December 3, 2008 Study Status and Contacts/Locations
137 December 4, 2008 Contacts/Locations and Study Status
138 December 6, 2008 Contacts/Locations and Study Status
139 December 9, 2008 Contacts/Locations and Study Status
140 December 10, 2008 Contacts/Locations and Study Status
141 December 16, 2008 Contacts/Locations and Study Status
142 December 17, 2008 Contacts/Locations and Study Status
143 December 19, 2008 Contacts/Locations and Study Status
144 December 24, 2008 Contacts/Locations and Study Status
145 December 25, 2008 Contacts/Locations and Study Status
146 December 31, 2008 Contacts/Locations and Study Status
147 January 6, 2009 Study Status and Contacts/Locations
148 January 7, 2009 Contacts/Locations and Study Status
149 January 9, 2009 Contacts/Locations and Study Status
150 January 10, 2009 Contacts/Locations and Study Status
151 January 14, 2009 Contacts/Locations and Study Status
152 January 15, 2009 Contacts/Locations and Study Status
153 January 16, 2009 Contacts/Locations and Study Status
154 January 21, 2009 Contacts/Locations and Study Status
155 January 22, 2009 Contacts/Locations and Study Status
156 January 28, 2009 Contacts/Locations and Study Status
157 January 29, 2009 Contacts/Locations and Study Status
158 January 30, 2009 Contacts/Locations and Study Status
159 February 3, 2009 Contacts/Locations and Study Status
160 February 7, 2009 Contacts/Locations and Study Status
161 February 10, 2009 Contacts/Locations and Study Status
162 February 11, 2009 Contacts/Locations and Study Status
163 February 12, 2009 Contacts/Locations and Study Status
164 February 14, 2009 Contacts/Locations and Study Status
165 February 17, 2009 Contacts/Locations and Study Status
166 February 19, 2009 Contacts/Locations and Study Status
167 February 21, 2009 Contacts/Locations and Study Status
168 February 25, 2009 Contacts/Locations and Study Status
169 February 27, 2009 Contacts/Locations and Study Status
170 March 5, 2009 Study Status and Contacts/Locations
171 March 7, 2009 Contacts/Locations and Study Status
172 March 10, 2009 Contacts/Locations and Study Status
173 March 11, 2009 Contacts/Locations and Study Status
174 March 13, 2009 Contacts/Locations and Study Status
175 March 17, 2009 Contacts/Locations and Study Status
176 March 18, 2009 Contacts/Locations and Study Status
177 March 19, 2009 Contacts/Locations and Study Status
178 March 21, 2009 Contacts/Locations and Study Status
179 March 27, 2009 Contacts/Locations and Study Status
180 March 31, 2009 Contacts/Locations and Study Status
181 April 3, 2009 Study Status and Contacts/Locations
182 April 6, 2009 Contacts/Locations and Study Status
183 April 7, 2009 Arms and Interventions and Study Status
184 April 8, 2009 Contacts/Locations and Study Status
185 April 9, 2009 Contacts/Locations and Study Status
186 April 10, 2009 Contacts/Locations and Study Status
187 April 11, 2009 Contacts/Locations and Study Status
188 April 14, 2009 Sponsor/Collaborators and Study Status
189 April 22, 2009 Contacts/Locations and Study Status
190 April 26, 2009 Contacts/Locations and Study Status
191 April 28, 2009 Contacts/Locations and Study Status
192 May 2, 2009 Study Status and Contacts/Locations
193 May 7, 2009 Contacts/Locations and Study Status
194 May 9, 2009 Contacts/Locations and Study Status
195 May 12, 2009 Contacts/Locations and Study Status
196 May 13, 2009 Contacts/Locations and Study Status
197 May 15, 2009 Contacts/Locations and Study Status
198 May 19, 2009 Contacts/Locations and Study Status
199 May 26, 2009 Contacts/Locations and Study Status
200 June 3, 2009 Contacts/Locations and Study Status
201 June 9, 2009 Contacts/Locations and Study Status
202 June 17, 2009 Contacts/Locations and Study Status
203 June 20, 2009 Contacts/Locations and Study Status
204 June 26, 2009 Contacts/Locations and Study Status
205 July 3, 2009 Study Status and Contacts/Locations
206 July 9, 2009 Contacts/Locations and Study Status
207 July 11, 2009 Contacts/Locations and Study Status
208 July 14, 2009 Contacts/Locations and Study Status
209 July 16, 2009 Contacts/Locations and Study Status
210 July 21, 2009 Contacts/Locations and Study Status
211 July 23, 2009 Contacts/Locations and Study Status
212 July 25, 2009 Contacts/Locations and Study Status
213 August 1, 2009 Contacts/Locations and Study Status
214 August 5, 2009 Study Status and Contacts/Locations
215 August 11, 2009 Contacts/Locations and Study Status
216 August 13, 2009 Contacts/Locations and Study Status
217 August 14, 2009 Contacts/Locations and Study Status
218 August 16, 2009 Contacts/Locations and Study Status
219 August 20, 2009 Contacts/Locations and Study Status
220 August 25, 2009 Contacts/Locations and Study Status
221 August 26, 2009 Contacts/Locations and Study Status
222 August 28, 2009 Contacts/Locations and Study Status
223 September 8, 2009 Study Status and Contacts/Locations
224 September 11, 2009 Contacts/Locations and Study Status
225 September 15, 2009 Contacts/Locations and Study Status
226 September 17, 2009 Contacts/Locations and Study Status
227 September 23, 2009 Contacts/Locations and Study Status
228 September 29, 2009 Contacts/Locations and Study Status
229 September 30, 2009 Contacts/Locations and Study Status
230 October 1, 2009 Contacts/Locations and Study Status
231 October 6, 2009 Study Status and Contacts/Locations
232 October 7, 2009 Contacts/Locations and Study Status
233 October 13, 2009 Contacts/Locations and Study Status
234 October 15, 2009 Contacts/Locations and Study Status
235 October 16, 2009 Contacts/Locations and Study Status
236 October 20, 2009 Contacts/Locations and Study Status
237 October 21, 2009 Contacts/Locations and Study Status
238 October 29, 2009 Contacts/Locations and Study Status
239 October 30, 2009 Contacts/Locations and Study Status
240 November 3, 2009 Contacts/Locations and Study Status
241 November 4, 2009 Study Status and Contacts/Locations
242 November 7, 2009 Contacts/Locations and Study Status
243 November 10, 2009 Contacts/Locations and Study Status
244 November 12, 2009 Contacts/Locations and Study Status
245 November 18, 2009 Contacts/Locations and Study Status
246 December 2, 2009 Study Status and Contacts/Locations
247 December 5, 2009 Contacts/Locations and Study Status
248 December 11, 2009 Contacts/Locations and Study Status
249 December 15, 2009 Contacts/Locations and Study Status
250 December 17, 2009 Contacts/Locations and Study Status
251 December 22, 2009 Contacts/Locations and Study Status
252 December 23, 2009 Contacts/Locations and Study Status
253 January 7, 2010 Study Status and Contacts/Locations
254 January 12, 2010 Contacts/Locations and Study Status
255 January 15, 2010 Contacts/Locations and Study Status
256 January 22, 2010 Contacts/Locations and Study Status
257 January 23, 2010 Contacts/Locations and Study Status
258 January 26, 2010 Contacts/Locations and Study Status
259 January 27, 2010 Contacts/Locations and Study Status
260 January 28, 2010 Contacts/Locations and Study Status
261 January 29, 2010 Contacts/Locations and Study Status
262 February 1, 2010 Contacts/Locations and Study Status
263 February 2, 2010 Contacts/Locations and Study Status
264 February 3, 2010 Study Status
265 February 4, 2010 Contacts/Locations and Study Status
266 February 6, 2010 Contacts/Locations and Study Status
267 February 11, 2010 Contacts/Locations and Study Status
268 February 16, 2010 Contacts/Locations and Study Status
269 February 18, 2010 Contacts/Locations and Study Status
270 February 19, 2010 Contacts/Locations and Study Status
271 February 20, 2010 Contacts/Locations and Study Status
272 February 23, 2010 Contacts/Locations and Study Status
273 February 25, 2010 Contacts/Locations and Study Status
274 February 26, 2010 Contacts/Locations and Study Status
275 March 2, 2010 Contacts/Locations and Study Status
276 March 3, 2010 Study Status and Contacts/Locations
277 March 4, 2010 Contacts/Locations and Study Status
278 March 9, 2010 Contacts/Locations and Study Status
279 March 10, 2010 Contacts/Locations and Study Status
280 March 11, 2010 Contacts/Locations and Study Status
281 March 12, 2010 Contacts/Locations and Study Status
282 March 16, 2010 Contacts/Locations and Study Status
283 March 18, 2010 Contacts/Locations and Study Status
284 March 22, 2010 Contacts/Locations and Study Status
285 March 24, 2010 Contacts/Locations and Study Status
286 March 26, 2010 Contacts/Locations and Study Status
287 March 27, 2010 Contacts/Locations and Study Status
288 March 30, 2010 Contacts/Locations and Study Status
289 April 1, 2010 Contacts/Locations and Study Status
290 April 6, 2010 Study Status and Contacts/Locations
291 April 7, 2010 Contacts/Locations and Study Status
292 April 8, 2010 Contacts/Locations and Study Status
293 April 13, 2010 Contacts/Locations and Study Status
294 April 15, 2010 Contacts/Locations and Study Status
295 April 17, 2010 Contacts/Locations and Study Status
296 April 21, 2010 Contacts/Locations and Study Status
297 May 8, 2010 Study Status and Contacts/Locations
298 May 11, 2010 Contacts/Locations and Study Status
299 May 12, 2010 Contacts/Locations and Study Status
300 May 15, 2010 Contacts/Locations and Study Status
301 May 18, 2010 Contacts/Locations and Study Status
302 May 27, 2010 Contacts/Locations and Study Status
303 May 28, 2010 Contacts/Locations and Study Status
304 June 5, 2010 Study Status and Contacts/Locations
305 June 8, 2010 Contacts/Locations and Study Status
306 June 9, 2010 Contacts/Locations and Study Status
307 June 11, 2010 Contacts/Locations and Study Status
308 June 19, 2010 Contacts/Locations and Study Status
309 June 22, 2010 Contacts/Locations and Study Status
310 June 24, 2010 Contacts/Locations and Study Status
311 June 25, 2010 Contacts/Locations and Study Status
312 June 26, 2010 Contacts/Locations and Study Status
313 June 29, 2010 Contacts/Locations and Study Status
314 July 2, 2010 Study Status and Contacts/Locations
315 July 3, 2010 Contacts/Locations and Study Status
316 July 13, 2010 Contacts/Locations and Study Status
317 July 14, 2010 Contacts/Locations and Study Status
318 July 17, 2010 Contacts/Locations and Study Status
319 July 21, 2010 Contacts/Locations and Study Status
320 July 28, 2010 Contacts/Locations, Sponsor/Collaborators and Study Status
321 August 3, 2010 Study Status and Contacts/Locations
322 August 5, 2010 Contacts/Locations and Study Status
323 August 6, 2010 Contacts/Locations and Study Status
324 August 10, 2010 Contacts/Locations and Study Status
325 August 11, 2010 Contacts/Locations and Study Status
326 August 14, 2010 Contacts/Locations and Study Status
327 August 18, 2010 Contacts/Locations and Study Status
328 August 20, 2010 Contacts/Locations and Study Status
329 August 24, 2010 Contacts/Locations and Study Status
330 August 29, 2010 Contacts/Locations and Study Status
331 September 10, 2010 Contacts/Locations and Study Status
332 September 17, 2010 Conditions and Study Status
333 September 18, 2010 Contacts/Locations and Study Status
334 September 24, 2010 Contacts/Locations and Study Status
335 September 25, 2010 Contacts/Locations and Study Status
336 September 28, 2010 Contacts/Locations and Study Status
337 October 6, 2010 Study Status and Contacts/Locations
338 October 8, 2010 Contacts/Locations and Study Status
339 October 12, 2010 Contacts/Locations and Study Status
340 October 13, 2010 Contacts/Locations and Study Status
341 October 16, 2010 Contacts/Locations and Study Status
342 October 19, 2010 Contacts/Locations and Study Status
343 October 20, 2010 Contacts/Locations and Study Status
344 October 21, 2010 Contacts/Locations and Study Status
345 October 23, 2010 Contacts/Locations and Study Status
346 October 26, 2010 Contacts/Locations and Study Status
347 October 28, 2010 Contacts/Locations and Study Status
348 October 29, 2010 Contacts/Locations and Study Status
349 October 30, 2010 Contacts/Locations and Study Status
350 November 2, 2010 Contacts/Locations and Study Status
351 November 3, 2010 Contacts/Locations and Study Status
352 November 5, 2010 Contacts/Locations and Study Status
353 November 9, 2010 Contacts/Locations and Study Status
354 November 10, 2010 Contacts/Locations and Study Status
355 November 12, 2010 Contacts/Locations and Study Status
356 November 18, 2010 Contacts/Locations and Study Status
357 November 20, 2010 Contacts/Locations and Study Status
358 November 23, 2010 Contacts/Locations and Study Status
359 December 1, 2010 Contacts/Locations and Study Status
360 December 4, 2010 Study Status and Contacts/Locations
361 December 7, 2010 Contacts/Locations and Study Status
362 December 8, 2010 Contacts/Locations and Study Status
363 December 15, 2010 Contacts/Locations and Study Status
364 December 16, 2010 Contacts/Locations and Study Status
365 December 21, 2010 Contacts/Locations and Study Status
366 December 22, 2010 Contacts/Locations and Study Status
367 December 24, 2010 Contacts/Locations and Study Status
368 January 7, 2011 Study Status
369 January 8, 2011 Contacts/Locations and Study Status
370 January 20, 2011 Contacts/Locations and Study Status
371 January 25, 2011 Contacts/Locations and Study Status
372 January 26, 2011 Contacts/Locations and Study Status
373 January 27, 2011 Contacts/Locations and Study Status
374 February 5, 2011 Study Status and Contacts/Locations
375 February 10, 2011 Contacts/Locations and Study Status
376 February 15, 2011 Contacts/Locations and Study Status
377 February 22, 2011 Contacts/Locations and Study Status
378 February 25, 2011 Contacts/Locations and Study Status
379 March 1, 2011 Contacts/Locations and Study Status
380 March 3, 2011 Study Status and Contacts/Locations
381 March 4, 2011 Contacts/Locations and Study Status
382 March 9, 2011 Contacts/Locations and Study Status
383 March 11, 2011 Contacts/Locations and Study Status
384 March 16, 2011 Recruitment Status, Study Status and Contacts/Locations
385 April 5, 2011 Study Status
386 February 8, 2012 Outcome Measures, Sponsor/Collaborators, Study Status, Study Identification, Contacts/Locations, Study Design, Study Description and Oversight
387 July 26, 2012 Study Design, Study Status and Study Identification
388 May 15, 2013 Contacts/Locations, Study Identification, Arms and Interventions, Outcome Measures, Sponsor/Collaborators, Study Status, Study Design, Conditions, Study Description, References, Eligibility and Oversight
389 November 6, 2013 Contacts/Locations, Study Identification, Arms and Interventions, Outcome Measures, Sponsor/Collaborators, Study Status, Study Design, Conditions, Study Description, References, Eligibility and Oversight
390 May 16, 2014 Study Status and Eligibility
391 June 3, 2014 Contacts/Locations and Study Status
392 July 10, 2014 Contacts/Locations and Study Status
393 March 24, 2015 Study Status and Outcome Measures
394 March 7, 2016 Study Status, Arms and Interventions, Outcome Measures, Study Identification, References, Results, Eligibility, Study Description and Oversight
395 September 26, 2016 Study Identification and Study Status
396 December 22, 2017 Contacts/Locations, Study Status and Outcome Measures
397 March 15, 2019 Outcome Measures and Study Status
398 March 9, 2020 Outcome Measures and Study Status
399 March 18, 2020 Study Status
400 August 4, 2020 Study Status
401 February 12, 2021 Study Status
402 November 15, 2022 Study Status and Study Identification
403 December 14, 2023 More Information, Study Status and References
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Study NCT00066703
Submitted Date:  September 26, 2016 (v395)
Open or close this module Study Identification
Unique Protocol ID: IBCSG 25-02 / BIG 3-02
Brief Title: Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer (TEXT)
Official Title: A Phase III Trial Evaluating The Role Of Exemestane Plus GnRH Analogue As Adjuvant Therapy For Premenopausal Women With Endocrine Responsive Breast Cancer
Secondary IDs: IBCSG 25-02
BIG 3-02 [Breast International Group]
NABCI IBCSG 25-02
EU-20347
2004-000168-28 [EudraCT Number]
CDR0000316458 [Registry Identifier: CT.gov]
Open or close this module Study Status
Record Verification: September 2016
Overall Status: Active, not recruiting
Study Start: August 2003
Primary Completion: June 2014 [Actual]
Study Completion: June 2020 [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:		 March 7, 2016
Results First Posted: April 5, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:		 September 26, 2016
Last Update Posted: October 28, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: ETOP IBCSG Partners Foundation
Responsible Party: Sponsor
Collaborators: National Cancer Institute (NCI)
Breast International Group
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 cancer cells. Hormone therapy using triptorelin, exemestane, and tamoxifen may fight breast cancer by blocking the use of estrogen. It is not yet known whether giving triptorelin together with exemestane is more effective than triptorelin and tamoxifen in treating hormone-responsive breast cancer.

PURPOSE: This randomized phase III trial is studying triptorelin and exemestane to see how well they work compared to triptorelin and tamoxifen in treating premenopausal women with 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 triptorelin and exemestane vs triptorelin and tamoxifen.
  • Compare the quality of life, including late side effects of early menopause, of patients treated with these regimens.

OUTLINE: This is a randomized, international, multicenter study. Patients are stratified according to planned use of concurrent adjuvant chemotherapy (yes vs no), and number of positive lymph nodes (0 vs 1 or more). 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 annually for 3 years.
Open or close this module Conditions
Conditions: Breast Cancer
Keywords: stage II breast cancer
stage IIIA breast cancer
estrogen receptor-positive breast cancer
progesterone receptor-positive breast cancer
stage IA breast cancer
stage IB breast cancer
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: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 2672 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: T+OFS
Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
 Drug: tamoxifen
Other Names:
  • Nolvadex
Drug: triptorelin
Other Names:
  • GnRH analogue
  • Trelstar Depot
  • Decapeptyl Depot
Experimental: E+OFS
Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
 Drug: exemestane
Other Names:
  • Aromasin
Drug: triptorelin
Other Names:
  • 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 estimate reported at a median follow-up of 72 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 estimate reported at a median follow-up of 72 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 the 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 72 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 breast cancer recurrence at a distant site; or censored at date of last follow-up
3. Overall Survival
[ Time Frame: 5-year estimates ]

Estimated percentage of patients alive and disease-free at 5 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:

DISEASE CHARACTERISTICS:

  • Histologically confirmed breast cancer
  • Completely resected disease
    • No clinically detectable residual loco-regional axillary disease
    • Prior surgery for primary breast cancer of 1 of the following types:
      • Total mastectomy with or without adjuvant radiotherapy
      • Breast-conserving procedure (e.g., lumpectomy, quadrantectomy, or partial mastectomy with margins negative* for invasive disease and ductal carcinoma in situ) with planned radiotherapy NOTE: *If all other margins are clear a positive posterior (deep) margin is permitted, provided the excision was performed down to the pectoral fascia and all tumor has been removed OR a positive anterior (superficial; abutting skin) margin is allowed provided all tumor was removed
  • Tumor confined to the breast and axillary nodes
    • Tumor detected in internal mammary chain nodes by sentinel node procedure and is not enlarged is allowed
  • Axillary lymph node dissection or a negative axillary sentinel node biopsy required
    • Patients with negative or microscopically positive axillary sentinel nodes are eligible
    • Positive sentinel nodes must have either axillary dissection or radiation of axillary nodes
  • No distant metastases
  • No locally advanced inoperable breast cancer, including any of the following:
    • Inflammatory breast cancer
    • Supraclavicular node involvement
    • Enlarged internal mammary nodes (unless pathologically negative)
  • Bilateral synchronous invasive breast cancer allowed if disease meets all other eligibility criteria
  • No prior ipsilateral or contralateral invasive breast cancer
  • Hormone receptor status:
    • Estrogen and/or progesterone receptor positive
      • At least 10% of the tumor cells positive by immunohistochemistry
      • If > 1 breast tumor, each tumor must be hormone receptor positive

PATIENT CHARACTERISTICS:

Age

  • Premenopausal

Sex

  • Female

Menopausal status

  • Premenopausal
    • Estradiol in the premenopausal range after prior surgery OR meets the following criteria:
      • Menstruating regularly for the past 6 months
      • Has not used any form of hormonal treatment (including hormonal contraception) within the past 6 months

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • No systemic hepatic disease that would preclude prolonged follow-up

Renal

  • No systemic renal disease that would preclude prolonged follow-up

Cardiovascular

  • No systemic cardiovascular disease that would preclude prolonged follow-up
  • No prior thrombosis (e.g., deep vein thrombosis) and/or embolism unless patient is medically suitable

Pulmonary

  • No systemic pulmonary disease that would preclude prolonged follow-up

Other

  • Not pregnant or nursing
  • Fertile patients must use effective nonhormonal contraception
  • No history of noncompliance to medical regimens
  • No other nonmalignant systemic disease that would preclude prolonged follow-up
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, nonbreast carcinoma in situ, contralateral or ipsilateral carcinoma in situ of the breast, or other nonrecurrent invasive nonbreast malignancy, including any of the following:
    • Stage I papillary thyroid cancer
    • Stage IA carcinoma of the cervix
    • Stage IA or B endometrioid endometrial cancer
    • Borderline or stage I ovarian cancer
  • No psychiatric, addictive, or other disorder that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Prior or concurrent neoadjuvant or adjuvant trastuzumab allowed

Chemotherapy

  • No prior neoadjuvant or adjuvant chemotherapy

Endocrine therapy

  • No prior tamoxifen, other selective estrogen-receptor modulators (SERMs) (e.g., raloxifene), or hormone replacement therapy for more than 1 year before breast cancer diagnosis
  • No prior neoadjuvant or adjuvant endocrine therapy since diagnosis of breast cancer
  • No concurrent oral or transdermal hormonal therapy
  • No other concurrent estrogen, progesterone, or androgens
  • No other concurrent aromatase inhibitors
  • No concurrent oral or other hormonal contraceptives (i.e., implants or depot injections)

Radiotherapy

  • See Disease Characteristics
  • No prior ovarian radiotherapy

Surgery

  • See Disease Characteristics
  • No prior bilateral oophorectomy

Other

  • No concurrent bisphosphonates, except in the following cases:
    • Bone density is at least 1.5 standard deviations below the young adult normal mean
    • Participation in a randomized clinical study testing bisphosphonates in the adjuvant breast cancer setting
  • No other concurrent investigational agents
Open or close this module Contacts/Locations
Study Officials: Olivia Pagani, MD
Study Chair
Oncology Institute of Southern Switzerland
Barbara Walley, MD, FRCPC
Study Chair
Tom Baker Cancer Centre
Locations: United States, California
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
Burbank, California, United States, 91505
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
Providence Holy Cross Cancer Center
Mission Hills, California, United States, 91346-9600
Desert Regional Medical Center Comprehensive Cancer Center
Palm Springs, California, United States, 92262
Sutter Cancer Center at Roseville Medical Center
Roseville, California, United States, 95661
Sutter Cancer Center
Sacramento, California, United States, 95816
Mercy General Hospital
Sacramento, California, United States, 95819
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
Ruby L. Golleher Cancer Program at Presbyterian Intercommunity Hospital
Whittier, California, United States, 90602
United States, Colorado
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States, 80045
Shaw Regional Cancer Center
Edwards, Colorado, United States, 81632
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
Front Range Cancer Specialists
Fort Collins, Colorado, United States, 80528
United States, Connecticut
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
Farmington, Connecticut, United States, 06360-2875
United States, District of Columbia
Sibley Memorial Hospital
Washington, District of Columbia, United States, 20016
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5001
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
United States, Georgia
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
United States, Idaho
Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise, Idaho, United States, 83712
Kootenai Cancer Center - Coeur d'Alene
Coeur d'Alene, Idaho, United States, 83814
United States, Illinois
Resurrection Medical Center
Chicago, Illinois, United States, 60631
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Evanston Hospital
Evanston, Illinois, United States, 60201-1781
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Elkhart Clinic, LLC
Elkhart, Indiana, United States, 46514-2098
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States, 46845
Howard Community Hospital
Kokomo, Indiana, United States, 46904
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Saint Joseph Regional Medical Center
Mishawaka, Indiana, United States, 46545-1470
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Michiana Hematology-Oncology, PC - South Bend
South Bend, Indiana, United States, 46601
South Bend Clinic
South Bend, Indiana, United States, 46617
United States, Iowa
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
United States, Kansas
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States, 67114
Menorah Medical Center
Overland Park, Kansas, United States, 66209
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States, 67401
Shawnee Mission Medical Center
Shawnee Mission, Kansas, United States, 66204
Cotton-O'Neil Cancer Center
Topeka, Kansas, United States, 66606
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States, 67152
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States, 67214
CCOP - Wichita
Wichita, Kansas, United States, 67214
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States, 67156
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Mercy Medical Center
Baltimore, Maryland, United States, 21202
Suburban Hospital
Bethesda, Maryland, United States, 20814
Frederick Memorial Hospital Regional Cancer Therapy Center
Frederick, Maryland, United States, 21701
United States, Massachusetts
Tufts Medical Center Cancer Center
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Bethke Cancer Center at Emerson Hospital
Concord, Massachusetts, United States, 01742
Addison Gilbert Hospital
Gloucester, Massachusetts, United States, 01930
Lowell General Hospital
Lowell, Massachusetts, United States, 01854
NSMC Cancer Center - Peabody
Peabody, Massachusetts, United States, 01960
United States, Michigan
MidMichigan Medical Center - Midland
Midland, Michigan, United States, 48670
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
Lakeside Cancer Specialists, PLLC
Saint Joseph, Michigan, United States, 49085
Lakeland Regional Cancer Care Center - St. Joseph
St. Joseph, Michigan, United States, 49085
United States, Minnesota
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, United States, 55109
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55415
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States, 55422-2900
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, United States, 55416
United Hospital
Saint Paul, Minnesota, United States, 55102
Regions Hospital Cancer Care Center
St. Paul, Minnesota, United States, 55101
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
United States, Missouri
Truman Medical Center - Hospital Hill
Kansas City, Missouri, United States, 64108
Saint Luke's Cancer Institute at Saint Luke's Hospital
Kansas City, Missouri, United States, 64111
St. Joseph Medical Center
Kansas City, Missouri, United States, 64114
North Kansas City Hospital
Kansas City, Missouri, United States, 64116
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
Research Medical Center
Kansas City, Missouri, United States, 64132
Heartland Regional Medical Center
Saint Joseph, Missouri, United States, 64506
Saint Louis University Cancer Center
Saint Louis, Missouri, United States, 63110
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
Grand Island, Nebraska, United States, 68803
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-6805
United States, New Jersey
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, United States, 08053
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
Vineland, New Jersey, United States, 08360
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees, New Jersey, United States, 08043
United States, New York
Our Lady of Mercy Medical Center Comprehensive Cancer Center
Bronx, New York, United States, 10466
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016
United States, North Carolina
Randolph Hospital
Asheboro, North Carolina, United States, 27203-5400
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States, 28801
Hope A Women's Cancer Center
Asheville, North Carolina, United States, 28816
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Greensboro, North Carolina, United States, 27403-1198
Pardee Memorial Hospital
Hendersonville, North Carolina, United States, 28791
Kinston Medical Specialists
Kinston, North Carolina, United States, 28501
Annie Penn Cancer Center
Reidsville, North Carolina, United States, 27320
United States, Ohio
Aultman Cancer Center at Aultman Hospital
Canton, Ohio, United States, 44710-1799
MetroHealth Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
United States, Pennsylvania
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States, 17822-0001
Geisinger Hazleton Cancer Center
Hazleton, Pennsylvania, United States, 18201
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, United States, 16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
United States, South Dakota
Medical X-Ray Center, PC
Sioux Falls, South Dakota, United States, 57105
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Tennessee
Erlanger Cancer Center at Erlanger Hospital - Baroness
Chattanooga, Tennessee, United States, 37403
West Tennessee Cancer Center at Jackson-Madison County General Hospital
Jackson, Tennessee, United States, 38301
United States, Texas
Doctor's Hospital of Laredo
Laredo, Texas, United States, 78041
United States, Vermont
Mountainview Medical
Berlin, Vermont, United States, 05602
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States, 05401
United States, Washington
Madigan Army Medical Center - Tacoma
Tacoma, Washington, United States, 98431
United States, West Virginia
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Langlade Memorial Hospital
Antigo, Wisconsin, United States, 54409
Aurora Memorial Hospital of Burlington
Burlington, Wisconsin, United States, 53105
Oncology Alliance - Franklin
Franklin, Wisconsin, United States, 53132
Oncology Alliance, SC - Milwaukee - East
Glendale, Wisconsin, United States, 53212-1038
Oncology Alliance - Kenosha South
Kenosha, Wisconsin, United States, 53143
Aurora Advanced Healthcare East Mequon Clinic
Mequon, Wisconsin, United States, 53092
Columbia-Saint Mary's Hospital-Ozaukee
Mequon, Wisconsin, United States, 53097
Columbia Saint Mary's Water Tower Medical Commons Milwaukee
Mequon, Wisconsin, United States, 53211
Oncology Alliance, SC - Milwaukee - South
Milwaukee, Wisconsin, United States, 53215
Aurora Health Center - Racine
Racine, Wisconsin, United States, 53406-5661
Aurora Health Center - Waukesha
Waukesha, Wisconsin, United States, 53188
University of Wisconcin Cancer Center at Aspirus Wausau Hospital
Wausau, Wisconsin, United States, 54401
Oncology Alliance, SC - Milwaukee - West
Wauwatosa, Wisconsin, United States, 53226
Australia, New South Wales
Cancer Therapy Centre at Campbelltown Hospital
Campbelltown, New South Wales, Australia, 2560
Coffs Harbour Health Campus
Coffs Harbour, New South Wales, Australia, 2450
Lismore Base Hospital
Lismore, New South Wales, Australia, 2480
Cancer Therapy Centre at Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
Tamworth Base Hospital
Tamworth, New South Wales, Australia, 2340
Manning Base Hospital
Taree, New South Wales, Australia, 2430
Tweed Heads Hospital
Tweed Heads, New South Wales, Australia, 2485
Newcastle Mater Misericordiae Hospital
Waratah, New South Wales, Australia, 2298
Australia, Queensland
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia, 4029
Australia, South Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Australia, Tasmania
Royal Hobart Hospital
Hobart, Tasmania, Australia, 7000
Launceston General Hospital
Launceston, Tasmania, Australia, 7250
Australia, Victoria
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Breast Unit Mercy Private
East Melbourne, Victoria, Australia, 3002
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia, 3002
Maroondah Hospital
East Ringwood, Victoria, Australia, 3135
St. Vincent's Hospital - Melbourne
Fitzroy, Victoria, Australia, 3065
Austin Hospital
Heidelberg, Victoria, Australia, 3084
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Belgium
Institut Jules Bordet
Brussels, Belgium, 1000
Centre Hospitalier Hutois
Huy, Belgium, 4500
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
CHU Liege - Domaine Universitaire du Sart Tilman
Liege, Belgium, B-4000
Centre Hospitalier Peltzer-La Tourelle
Verviers, Belgium, B-4800
Brazil, Rio Grande do Sul
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
Canada, Alberta
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, Canada, T6G 1Z2
Canada, New Brunswick
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, Canada, E1C 8X3
Canada, Ontario
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Trillium Health Centre - Mississauga Site
Toronto, Ontario, Canada, M9C 1A5
Windsor Regional Cancer Centre at Windsor Regional Hospital
Windsor, Ontario, Canada, N8W 2X3
Canada, Quebec
Hopital Charles Lemoyne
Greenfield Park, Quebec, Canada, J4V 2H1
Canada, Saskatchewan
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre at the University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 4H4
Egypt
National Cancer Institute of Egypt
Cairo, Egypt
Cairo Oncology Center
Mohandeseen, Egypt
Germany
Brustzentrum Klinikum Mittelbaden
Baden-Baden, Germany, 76532
Klinikum Deggendorf
Deggendorf, Germany, 94469
Frauenklinik des Universitaetsklinikum Erlangen
Erlangen, Germany, 91054
Universitaetsfrauenklinik Frankfurt
Frankfurt, Germany, D-60596
Universitaets-Frauenklinik Goettingen
Goettingen, Germany, D-37075
St. Vincentius - Kliniken
Karlsruhe, Germany, D-76137
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
Luebeck, Germany, D-23538
Universitatsklinik Mainz
Mainz, Germany, 55101
Universitaetsfrauenklinik Mannheim
Mannheim, Germany, 68167
Klinikum Schwaebisch Gmuend Stauferklinik
Mutlangen, Germany, D-73557
Klinikum Nuernberg - Klinikum Nord
Nuremberg, Germany, D-90419
Caritas - Krankenhaus Saint Josef
Regensburg, Germany, 93053
Klinikum Obergoeltzsch Rodewisch
Rodewisch, Germany, 08228
Klinikum Rosenheim
Rosenheim, Germany, 83022
Klinikum Landkreis Tuttlingen
Tuttlingen, Germany, 78532
Hungary
National Institute of Oncology
Budapest, Hungary, 1122
India
Tata Memorial Hospital
Mumbai, India, 400012
Italy
Centro di Riferimento Oncologico - Aviano
Aviano, Italy, 33081
Ospedali Riuniti di Bergamo
Bergamo, Italy, 24100
Azienda Sanitaria di Bolzano
Bolzano, Italy, 39100
Spedali Civili di Brescia
Brescia, Italy, 25124
Ospedale Civile Ramazzini
Carpi, Italy, 41012
European Institute of Oncology
Milan, Italy, 20141
Fondazione Salvatore Maugeri
Pavia, Italy, I-27100
Misericordia e Dolce Hospital
Prato, Italy, 59100
Ospedale Civile Rimini
Rimini, Italy, 47900
Istituto Clinico Humanitas
Rozzano, Italy, 20089
Policlinico Universitario Udine
Udine, Italy, 33100
Ospedale di Circolo e Fondazione Macchi
Varese, Italy, 21100
New Zealand
Waikato Hospital
Hamilton, New Zealand, 2020
Peru
Instituto Nacional de Enfermedades Neoplasicas
Lima, Peru, 34
Slovenia
Institute of Oncology - Ljubljana
Ljubljana, Slovenia, Sl-1000
South Africa
Sandton Oncology Centre
Johannesburg, South Africa, 2121
Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden, S-413 45
University Hospital of Linkoping
Linkoping, Sweden, S-581 85
Skaraborgs Hospital
Skovde, Sweden, 541 85
Switzerland
Universitaetsspital-Basel
Basel, Switzerland, CH-4031
Oncology Institute of Southern Switzerland
Bellinzona, Switzerland, CH-6500
Inselspital Bern
Bern, Switzerland, CH-3010
Oncocare Sonnenhof-Klinik Engeriedspital
Bern, Switzerland, CH-3012
Kantonsspital Graubuenden
Chur, Switzerland, CH-7000
Onkologie-Praxis ZeTup Chur
Chur, Switzerland, CH-7000
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, 1011
Ospedale "la Carita", Locarno
Locarno, Switzerland, 6600
Ospedale Civico
Lugano, Switzerland, CH-6903
Ospedale Beata Vergine
Mendrisio, Switzerland, CH-6850
Kantonsspital - St. Gallen
St. Gallen, Switzerland, CH-9007
Regionalspital
Thun, Switzerland, 3600
UniversitaetsSpital Zuerich
Zurich, Switzerland, CH-8091
United Kingdom, England
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
Peterborough Hospitals Trust
Peterborough, England, United Kingdom, PE3 6DA
South Tyneside District Hospital
South Shields, England, United Kingdom, NE34 0PL
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations: Francis P, Fleming G, Nasi ML, et al.: Tailored treatment investigations for premenopausal women with endocrine responsive (ER+ and/or PGR+) breast cancer: the SOFT, TEXT, and PERCHE trials. [Abstract] The Breast 12 (Suppl 1): A-P104, S44, 2003.
Regan MM, Pagani O, Walley B, Torrisi R, Perez EA, Francis P, Fleming GF, Price KN, Thurlimann B, Maibach R, Castiglione-Gertsch M, Coates AS, Goldhirsch A, Gelber RD; SOFT/TEXT/PERCHE Steering Committee and the International Breast Cancer Study Group. Premenopausal endocrine-responsive early breast cancer: who receives chemotherapy? Ann Oncol. 2008 Jul;19(7):1231-1241. doi: 10.1093/annonc/mdn037. Epub 2008 Mar 5. PubMed 18325918
Rabaglio M, Ruepp B; Soft/Text/Perche Steering Committee. Death due to liver failure during endocrine therapy for premenopausal breast cancer. Acta Oncol. 2010 Aug;49(6):874-6. doi: 10.3109/0284186X.2010.484813. No abstract available. PubMed 20482225
Regan MM, Pagani O, Fleming GF, Walley BA, Price KN, Rabaglio M, Maibach R, Ruepp B, Coates AS, Goldhirsch A, Colleoni M, Gelber RD, Francis PA; International Breast Cancer Study; GroupSOFT and TEXT Investigators. Adjuvant treatment of premenopausal women with endocrine-responsive early breast cancer: design of the TEXT and SOFT trials. Breast. 2013 Dec;22(6):1094-100. doi: 10.1016/j.breast.2013.08.009. Epub 2013 Oct 2. PubMed 24095609
[Study Results] Pagani O, Regan MM, Walley BA, Fleming GF, Colleoni M, Lang I, Gomez HL, Tondini C, Burstein HJ, Perez EA, Ciruelos E, Stearns V, Bonnefoi HR, Martino S, Geyer CE Jr, Pinotti G, Puglisi F, Crivellari D, Ruhstaller T, Winer EP, Rabaglio-Poretti M, Maibach R, Ruepp B, Giobbie-Hurder A, Price KN, Bernhard J, Luo W, Ribi K, Viale G, Coates AS, Gelber RD, Goldhirsch A, Francis PA; TEXT and SOFT Investigators; International Breast Cancer Study Group. Adjuvant exemestane with ovarian suppression in premenopausal breast cancer. N Engl J Med. 2014 Jul 10;371(2):107-18. doi: 10.1056/NEJMoa1404037. Epub 2014 Jun 1. PubMed 24881463
Links:
Available IPD/Information:
Study Results
Open or close this module Participant Flow
Recruitment Details 2672 patients were randomized between 7Nov03 and 7Apr11 at 182 centers in 15 countries.
Pre-assignment Details
 
Arm/Group Title T+OFS E+OFS
Arm/Group Description Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin. Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
Period Title: Overall Study
Started 1334 1338
Completed 722 756
Not Completed 612 582
Reason Not Completed
Adverse Event 80 111
Death 3 0
Lack of Efficacy 114 69
Lost to Follow-up 31 28
Withdrawal by Subject 38 63
Treatment ongoing 346 311
Open or close this module Baseline Characteristics
Arm/Group TitleT+OFSE+OFSTotal
Arm/Group DescriptionOvarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.Total of all reporting groups
Overall Number of Baseline Participants 1328 1332 2660
Baseline Analysis Population Description
Age, Continuous
Median (Inter-Quartile Range)
Unit of measure: years
Number Analyzed1328 Participants1332 Participants2660 Participants
Age
44(40 to 46)43(39 to 46)43(40 to 46)
Sex: Female, Male
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed1328 Participants1332 Participants2660 Participants
Female
1328
100%
1332
100%
2660
100%
Male
0
0%
0
0%
0
0%
Lymph-node status [1]
Measure Type: Number
Unit of measure: percent of participants
Number Analyzed1328 Participants1332 Participants2660 Participants
Negative
5252104
Positive
484896
 
[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 Analyzed1328 Participants1332 Participants2660 Participants
<=2 cm
6059119
>=2 cm
394079
unknown
112
 
[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 Analyzed1328 Participants1332 Participants2660 Participants
1
171734
2
5655111
3
262753
unknown
112
 
[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 Analyzed1328 Participants1332 Participants2660 Participants
Negative
8787174
Positive
121224
Unknown
112
 
[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 estimate reported at a median follow-up of 72 months
Outcome Measure Data
Analysis Population Description
Intention-to-treat
 
Arm/Group TitleT+OFSE+OFS
Arm/Group DescriptionOvarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
Overall Number of Participants Analyzed1328 1332
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
87.3(85.7 to 88.7) 91.1(89.7 to 92.3)
Statistical Analysis 1
Statistical Analysis OverviewComparison Group SelectionT+OFS, E+OFS
Comments[Not specified]
Type of Statistical TestSuperiority or Other (legacy)
Comments[Not specified]
Statistical Test of HypothesisP-Value.0002
Comments[Not specified]
MethodLog Rank
Comments[Not specified]
Method of EstimationEstimation ParameterHazard Ratio (HR)
Estimated Value0.717
Confidence Interval(2-sided) 95%
0.602 to 0.855
Estimation CommentsT+OFS is 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 the 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 estimate reported at a median follow-up of 72 months
Outcome Measure Data
Analysis Population Description
Intention-to-treat
 
Arm/Group TitleT+OFSE+OFS
Arm/Group DescriptionOvarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
Overall Number of Participants Analyzed1328 1332
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
88.8(87.3 to 90.1) 92.8(91.6 to 93.9)
Statistical Analysis 1
Statistical Analysis OverviewComparison Group SelectionT+OFS, E+OFS
Comments[Not specified]
Type of Statistical TestSuperiority or Other (legacy)
Comments[Not specified]
Statistical Test of HypothesisP-Value<.0001
Comments[Not specified]
MethodLog Rank
Comments[Not specified]
Method of EstimationEstimation ParameterHazard Ratio (HR)
Estimated Value0.664
Confidence Interval(2-sided) 95%
.548 to .804
Estimation CommentsT+OFS is the reference group for 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 breast cancer recurrence at a distant site; or censored at date of last follow-up
Time Frame 5-year estimates reported at a median follow-up of 72 months
Outcome Measure Data
Analysis Population Description
Intention-to-treat
 
Arm/Group TitleT+OFSE+OFS
Arm/Group DescriptionOvarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
Overall Number of Participants Analyzed1328 1332
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
92.0(90.7 to 93.1) 93.8(92.7 to 94.8)
Statistical Analysis 1
Statistical Analysis OverviewComparison Group SelectionT+OFS, E+OFS
Comments[Not specified]
Type of Statistical TestSuperiority or Other (legacy)
Comments[Not specified]
Statistical Test of HypothesisP-Value0.02
Comments[Not specified]
MethodLog Rank
Comments[Not specified]
Method of EstimationEstimation ParameterHazard Ratio (HR)
Estimated Value0.777
Confidence Interval(2-sided) 95%
0.624 to 0.967
Estimation CommentsT+OFS was the reference group in the estimation of the hazard ratio
4. Secondary Outcome:
Title Overall Survival
Description Estimated percentage of patients alive and disease-free at 5 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 5-year estimates
Anticipated Reporting Date December 2017
Outcome Measure Data Not Reported
Open or close this module Adverse Events
 
Time Frame Assessed every 3 months for the first year, then every 6 months until year 6. Reported at a median follow-up of 72 months.
Adverse Event Reporting Description Targeted adverse events and other grade 3 or higher adverse events were collected on CRFs, regardless of attribution. The safety population EXCLUDES patients who never started protocol-assigned therapy.
 
Arm/Group Title T+OFS E+OFS
Arm/Group Description Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin. Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
All-Cause Mortality
  T+OFSE+OFS
 Affected / At Risk (%)Affected / At Risk (%)
Total / /
Serious Adverse Events
  T+OFSE+OFS
 Affected / At Risk (%)Affected / At Risk (%)
Total 484 / 1321 (36.64%)496 / 1317 (37.66%)
Blood and lymphatic system disorders
Blood/Bone Marrow-Other (Specify) † A 0 / 1321 (0%)1 / 1317 (0.08%)
Febrile neutropenia † A 1 / 1321 (0.08%)1 / 1317 (0.08%)
Hemoglobin † A 3 / 1321 (0.23%)2 / 1317 (0.15%)
Hemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other) † A 1 / 1321 (0.08%)0 / 1317 (0%)
Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura or hemolytic uremic syndrome) † A 1 / 1321 (0.08%)0 / 1317 (0%)
Cardiac disorders
Cardiac Arrhythmia-Other (Specify) † A 1 / 1321 (0.08%)0 / 1317 (0%)
Cardiac-ischemia/infarction † A 2 / 1321 (0.15%)4 / 1317 (0.3%)
Left ventricular diastolic dysfunction † A 0 / 1321 (0%)1 / 1317 (0.08%)
Left ventricular systolic dysfunction † A 3 / 1321 (0.23%)1 / 1317 (0.08%)
Pain - Cardiac/heart † A 0 / 1321 (0%)1 / 1317 (0.08%)
Supraventricular and nodal arrhythmia - Atrial fibrillation † A 2 / 1321 (0.15%)2 / 1317 (0.15%)
Supraventricular and nodal arrhythmia - Sinus tachycardia † A 2 / 1321 (0.15%)0 / 1317 (0%)
Supraventricular and nodal arrhythmia - Supraventricular arrhythmia NOS † A 1 / 1321 (0.08%)0 / 1317 (0%)
Supraventricular and nodal arrhythmia - Supraventricular tachycardia † A 0 / 1321 (0%)1 / 1317 (0.08%)
Valvular heart disease † A 0 / 1321 (0%)1 / 1317 (0.08%)
Ear and labyrinth disorders
Auditory/Ear-Other (Specify) † A 1 / 1321 (0.08%)1 / 1317 (0.08%)
Endocrine disorders
Endocrine-Other (Specify) † A 1 / 1321 (0.08%)1 / 1317 (0.08%)
Thyroid function, high (hyperthyroidism, thyrotoxicosis) † A 2 / 1321 (0.15%)0 / 1317 (0%)
Thyroid function, low (hypothyroidism) † A 1 / 1321 (0.08%)1 / 1317 (0.08%)
Eye disorders
Cataract † A 1 / 1321 (0.08%)1 / 1317 (0.08%)
Retinal detachment † A 1 / 1321 (0.08%)1 / 1317 (0.08%)
Retinopathy † A 1 / 1321 (0.08%)0 / 1317 (0%)
Gastrointestinal disorders
Colitis † A 1 / 1321 (0.08%)0 / 1317 (0%)
Constipation † A 2 / 1321 (0.15%)0 / 1317 (0%)
Diarrhea † A 3 / 1321 (0.23%)1 / 1317 (0.08%)
Gastritis (including bile reflux gastritis) † A 0 / 1321 (0%)2 / 1317 (0.15%)
Gastrointestinal-Other (Specify) † A 1 / 1321 (0.08%)3 / 1317 (0.23%)
Hemorrhage, GI - Rectum † A 1 / 1321 (0.08%)1 / 1317 (0.08%)
Hemorrhage, GI - Varices (rectal) † A 1 / 1321 (0.08%)0 / 1317 (0%)
Hemorrhoids † A 2 / 1321 (0.15%)0 / 1317 (0%)
Nausea † A 9 / 1321 (0.68%)15 / 1317 (1.14%)
Obstruction, GI - Small bowel NOS † A 0 / 1321 (0%)1 / 1317 (0.08%)
Pain - Abdomen NOS † A 5 / 1321 (0.38%)3 / 1317 (0.23%)
Pain - Stomach † A 0 / 1321 (0%)2 / 1317 (0.15%)
Pancreatitis † A 1 / 1321 (0.08%)0 / 1317 (0%)
Perforation, GI - Duodenum † A 1 / 1321 (0.08%)0 / 1317 (0%)
Stricture/stenosis (including anastomotic), GI - Esophagus † A 1 / 1321 (0.08%)0 / 1317 (0%)
Ulcer, GI - Stomach † A 0 / 1321 (0%)1 / 1317 (0.08%)
Vomiting † A 1 / 1321 (0.08%)1 / 1317 (0.08%)
General disorders
Death not associated with CTCAE term - Sudden death † A 1 / 1321 (0.08%)0 / 1317 (0%)
Fatigue (asthenia, lethargy, malaise) † A 32 / 1321 (2.42%)41 / 1317 (3.11%)
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) † A 1 / 1321 (0.08%)0 / 1317 (0%)
Flu-like syndrome † A 1 / 1321 (0.08%)0 / 1317 (0%)
Injection site reaction/extravasation changes † A 1 / 1321 (0.08%)0 / 1317 (0%)
Pain - Chest/thorax NOS † A 0 / 1321 (0%)4 / 1317 (0.3%)
Pain-Other (Specify) † A 2 / 1321 (0.15%)0 / 1317 (0%)
Hepatobiliary disorders
Cholecystitis † A 5 / 1321 (0.38%)1 / 1317 (0.08%)
Hepatobiliary/Pancreas-Other (Specify) † A 5 / 1321 (0.38%)1 / 1317 (0.08%)
Liver dysfunction/failure (clinical) † A 5 / 1321 (0.38%)1 / 1317 (0.08%)
Obstruction, GI - Gallbladder † A 2 / 1321 (0.15%)0 / 1317 (0%)
Pain - Gallbladder † A 0 / 1321 (0%)1 / 1317 (0.08%)
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever) † A 7 / 1321 (0.53%)5 / 1317 (0.38%)
Allergy/Immunology-Other (Specify) † A 0 / 1321 (0%)1 / 1317 (0.08%)
Infections and infestations
Infection (documented clinically or microbiologically) w/Grade 3 or 4 neutrophils -Catheter-related † A 0 / 1321 (0%)1 / 1317 (0.08%)
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Wound † A 0 / 1321 (0%)1 / 1317 (0.08%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Appendix † A 1 / 1321 (0.08%)2 / 1317 (0.15%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Bronchus † A 1 / 1321 (0.08%)2 / 1317 (0.15%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Catheter-related † A 0 / 1321 (0%)2 / 1317 (0.15%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Foreign body (e.g., graft, implant) † A 4 / 1321 (0.3%)0 / 1317 (0%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Joint † A 0 / 1321 (0%)1 / 1317 (0.08%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Kidney † A 0 / 1321 (0%)1 / 1317 (0.08%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia) † A 5 / 1321 (0.38%)2 / 1317 (0.15%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Middle ear (otitis media) † A 0 / 1321 (0%)1 / 1317 (0.08%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Nerve-peripheral † A 1 / 1321 (0.08%)0 / 1317 (0%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Pelvis NOS † A 0 / 1321 (0%)1 / 1317 (0.08%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Salivary gland † A 0 / 1321 (0%)1 / 1317 (0.08%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Sinus † A 1 / 1321 (0.08%)1 / 1317 (0.08%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis) † A 8 / 1321 (0.61%)9 / 1317 (0.68%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Small bowel NOS † A 1 / 1321 (0.08%)0 / 1317 (0%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Soft tissue NOS † A 0 / 1321 (0%)2 / 1317 (0.15%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Stomach † A 1 / 1321 (0.08%)0 / 1317 (0%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Upper airway NOS † A 0 / 1321 (0%)2 / 1317 (0.15%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS † A 0 / 1321 (0%)1 / 1317 (0.08%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Wound † A 0 / 1321 (0%)2 / 1317 (0.15%)
Infection with unknown ANC - Appendix † A 1 / 1321 (0.08%)1 / 1317 (0.08%)
Infection with unknown ANC - Bronchus † A 0 / 1321 (0%)1 / 1317 (0.08%)
Infection with unknown ANC - Foreign body (e.g., graft, implant, prosthesis, stent) † A 1 / 1321 (0.08%)0 / 1317 (0%)
Infection with unknown ANC - Lung (pneumonia) † A 2 / 1321 (0.15%)0 / 1317 (0%)
Infection with unknown ANC - Skin (cellulitis) † A 2 / 1321 (0.15%)4 / 1317 (0.3%)
Infection-Other (Specify) † A 4 / 1321 (0.3%)2 / 1317 (0.15%)
Injury, poisoning and procedural complications
Fracture † A 11 / 1321 (0.83%)18 / 1317 (1.37%)
Intra-operative injury - Ureter † A 0 / 1321 (0%)1 / 1317 (0.08%)
Intra-operative injury - Vagina † A 0 / 1321 (0%)1 / 1317 (0.08%)
Thrombosis/embolism (vascular access-related) † A 29 / 1321 (2.2%)13 / 1317 (0.99%)
Vessel injury-vein - Extremity-upper † A 0 / 1321 (0%)1 / 1317 (0.08%)
Wound complication, non-infectious † A 1 / 1321 (0.08%)0 / 1317 (0%)
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase) † A 6 / 1321 (0.45%)3 / 1317 (0.23%)
AST, SGOT (serum glutamic oxaloacetic transaminase) † A 6 / 1321 (0.45%)4 / 1317 (0.3%)
Bilirubin (hyperbilirubinemia) † A 0 / 1321 (0%)1 / 1317 (0.08%)
Carbon monoxide diffusion capacity (DL(co)) † A 1 / 1321 (0.08%)0 / 1317 (0%)
Cholesterol, serum-high (hypercholesterolemia) † A 0 / 1321 (0%)1 / 1317 (0.08%)
GGT (gamma-glutamyl transpeptidase) † A 2 / 1321 (0.15%)4 / 1317 (0.3%)
INR (International Normalized Ratio of prothrombin time) † A 0 / 1321 (0%)1 / 1317 (0.08%)
Leukocytes (total WBC) † A 0 / 1321 (0%)3 / 1317 (0.23%)
Neutrophils/granulocytes (ANC/AGC) † A 2 / 1321 (0.15%)2 / 1317 (0.15%)
Weight loss † A 1 / 1321 (0.08%)2 / 1317 (0.15%)
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia) † A 0 / 1321 (0%)1 / 1317 (0.08%)
Calcium, serum-low (hypocalcemia) † A 0 / 1321 (0%)1 / 1317 (0.08%)
Dehydration † A 2 / 1321 (0.15%)1 / 1317 (0.08%)
Glucose, serum-high (hyperglycemia) † A 8 / 1321 (0.61%)8 / 1317 (0.61%)
Pancreatic endocrine: glucose intolerance † A 5 / 1321 (0.38%)8 / 1317 (0.61%)
Phosphate, serum-low (hypophosphatemia) † A 0 / 1321 (0%)1 / 1317 (0.08%)
Potassium, serum-low (hypokalemia) † A 0 / 1321 (0%)1 / 1317 (0.08%)
Sodium, serum-low (hyponatremia) † A 0 / 1321 (0%)1 / 1317 (0.08%)
Triglyceride, serum-high (hypertriglyceridemia) † A 0 / 1321 (0%)1 / 1317 (0.08%)
Musculoskeletal and connective tissue disorders
Extremity-upper (function) † A 0 / 1321 (0%)1 / 1317 (0.08%)
Joint-function † A 1 / 1321 (0.08%)1 / 1317 (0.08%)
Lymphedema-related fibrosis † A 0 / 1321 (0%)1 / 1317 (0.08%)
Musculoskeletal/Soft Tissue-Other (Specify) † A 3 / 1321 (0.23%)1 / 1317 (0.08%)
Osteoporosis † A 4 / 1321 (0.3%)8 / 1317 (0.61%)
Pain - Back † A 2 / 1321 (0.15%)0 / 1317 (0%)
Pain - Bone † A 1 / 1321 (0.08%)1 / 1317 (0.08%)
Pain - Chest wall † A 1 / 1321 (0.08%)1 / 1317 (0.08%)
Pain - Extremity-limb † A 1 / 1321 (0.08%)0 / 1317 (0%)
Pain - Joint † A 69 / 1321 (5.22%)139 / 1317 (10.55%)
Pain - Neck † A 1 / 1321 (0.08%)1 / 1317 (0.08%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy-possibly related to cancer treatment (Specify) † A 0 / 1321 (0%)1 / 1317 (0.08%)
Nervous system disorders
CNS cerebrovascular ischemia † A 9 / 1321 (0.68%)2 / 1317 (0.15%)
Dizziness † A 2 / 1321 (0.15%)3 / 1317 (0.23%)
Hemorrhage, CNS † A 1 / 1321 (0.08%)1 / 1317 (0.08%)
Memory impairment † A 1 / 1321 (0.08%)1 / 1317 (0.08%)
Neurology-Other (Specify) † A 2 / 1321 (0.15%)4 / 1317 (0.3%)
Neuropathy: cranial - CN V Motor-jaw muscles; Sensory-facial † A 2 / 1321 (0.15%)0 / 1317 (0%)
Neuropathy: motor † A 0 / 1321 (0%)2 / 1317 (0.15%)
Neuropathy: sensory † A 1 / 1321 (0.08%)0 / 1317 (0%)
Pain - Head/headache † A 9 / 1321 (0.68%)11 / 1317 (0.84%)
Pain - Neuralgia/peripheral nerve † A 2 / 1321 (0.15%)12 / 1317 (0.91%)
Seizure † A 1 / 1321 (0.08%)1 / 1317 (0.08%)
Syncope (fainting) † A 1 / 1321 (0.08%)4 / 1317 (0.3%)
Vasovagal episode † A 0 / 1321 (0%)1 / 1317 (0.08%)
Psychiatric disorders
Insomnia † A 54 / 1321 (4.09%)44 / 1317 (3.34%)
Mood alteration - anxiety † A 1 / 1321 (0.08%)3 / 1317 (0.23%)
Mood alteration - depression † A 59 / 1321 (4.47%)51 / 1317 (3.87%)
Psychosis (hallucinations/delusions) † A 0 / 1321 (0%)1 / 1317 (0.08%)
Renal and urinary disorders
Cystitis † A 1 / 1321 (0.08%)0 / 1317 (0%)
Incontinence, urinary † A 3 / 1321 (0.23%)2 / 1317 (0.15%)
Obstruction, GU - Ureter † A 0 / 1321 (0%)1 / 1317 (0.08%)
Renal/Genitourinary-Other (Specify) † A 24 / 1321 (1.82%)7 / 1317 (0.53%)
Reproductive system and breast disorders
Breast nipple/areolar deformity † A 0 / 1321 (0%)1 / 1317 (0.08%)
Hemorrhage, GU - Uterus † A 0 / 1321 (0%)1 / 1317 (0.08%)
Hemorrhage, GU - Vagina † A 4 / 1321 (0.3%)1 / 1317 (0.08%)
Irregular menses (change from baseline) † A 0 / 1321 (0%)1 / 1317 (0.08%)
Pain - Vagina † A 11 / 1321 (0.83%)33 / 1317 (2.51%)
Sexual/Reproductive Function-Other (Specify) † A 3 / 1321 (0.23%)1 / 1317 (0.08%)
Respiratory, thoracic and mediastinal disorders
Apnea † A 1 / 1321 (0.08%)0 / 1317 (0%)
Bronchospasm, wheezing † A 2 / 1321 (0.15%)0 / 1317 (0%)
Cough † A 0 / 1321 (0%)1 / 1317 (0.08%)
Dyspnea (shortness of breath) † A 1 / 1321 (0.08%)2 / 1317 (0.15%)
Hemorrhage, pulmonary/upper respiratory - Bronchopulmonary NOS † A 1 / 1321 (0.08%)0 / 1317 (0%)
Obstruction/stenosis of airway - Larynx † A 1 / 1321 (0.08%)0 / 1317 (0%)
Pleural effusion (non-malignant) † A 1 / 1321 (0.08%)0 / 1317 (0%)
Pneumonitis/pulmonary infiltrates † A 1 / 1321 (0.08%)1 / 1317 (0.08%)
Pneumothorax † A 1 / 1321 (0.08%)1 / 1317 (0.08%)
Pulmonary/Upper Respiratory-Other (Specify) † A 2 / 1321 (0.15%)2 / 1317 (0.15%)
Skin and subcutaneous tissue disorders
Pruritus/itching † A 1 / 1321 (0.08%)1 / 1317 (0.08%)
Rash/desquamation † A 1 / 1321 (0.08%)0 / 1317 (0%)
Skin breakdown/decubitus ulcer † A 1 / 1321 (0.08%)0 / 1317 (0%)
Vascular disorders
Hematoma † A 0 / 1321 (0%)1 / 1317 (0.08%)
Hot flashes/flushes † A 149 / 1321 (11.28%)127 / 1317 (9.64%)
Hypertension † A 100 / 1321 (7.57%)90 / 1317 (6.83%)
Hypotension † A 1 / 1321 (0.08%)0 / 1317 (0%)
Vascular-Other (Specify) † A 1 / 1321 (0.08%)0 / 1317 (0%)
Vasculitis † A 0 / 1321 (0%)1 / 1317 (0.08%)
†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%
  T+OFSE+OFS
 Affected / At Risk (%)Affected / At Risk (%)
Total 1293 / 1321 (97.88%)1298 / 1317 (98.56%)
Cardiac disorders
Cardiac-ischemia/infarction † A 2 / 1321 (0.15%)4 / 1317 (0.3%)
Gastrointestinal disorders
Nausea † A 446 / 1321 (33.76%)478 / 1317 (36.29%)
General disorders
Fatigue (asthenia, lethargy, malaise) † A 807 / 1321 (61.09%)760 / 1317 (57.71%)
Injection site reaction/extravasation changes † A 99 / 1321 (7.49%)86 / 1317 (6.53%)
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever) † A 56 / 1321 (4.24%)60 / 1317 (4.56%)
Injury, poisoning and procedural complications
Fracture † A 57 / 1321 (4.31%)82 / 1317 (6.23%)
Thrombosis/embolism (vascular access-related) † A 3 / 1321 (0.23%)3 / 1317 (0.23%)
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia) † A 30 / 1321 (2.27%)31 / 1317 (2.35%)
Pancreatic endocrine: glucose intolerance † A 16 / 1321 (1.21%)17 / 1317 (1.29%)
Musculoskeletal and connective tissue disorders
Osteoporosis † A 388 / 1321 (29.37%)588 / 1317 (44.65%)
Pain - Joint † A 953 / 1321 (72.14%)1030 / 1317 (78.21%)
Nervous system disorders
CNS cerebrovascular ischemia † A 2 / 1321 (0.15%)1 / 1317 (0.08%)
Hemorrhage, CNS † A 12 / 1321 (0.91%)7 / 1317 (0.53%)
Psychiatric disorders
Insomnia † A 738 / 1321 (55.87%)714 / 1317 (54.21%)
Libido † A 486 / 1321 (36.79%)555 / 1317 (42.14%)
Mood alteration - depression † A 592 / 1321 (44.81%)610 / 1317 (46.32%)
Renal and urinary disorders
Incontinence, urinary † A 232 / 1321 (17.56%)182 / 1317 (13.82%)
Reproductive system and breast disorders
Pain - Vagina † A 336 / 1321 (25.44%)374 / 1317 (28.4%)
Vaginal dryness † A 611 / 1321 (46.25%)683 / 1317 (51.86%)
Skin and subcutaneous tissue disorders
Sweating (diaphoresis) † A 752 / 1321 (56.93%)705 / 1317 (53.53%)
Vascular disorders
Hot flashes/flushes † A 1081 / 1321 (81.83%)1076 / 1317 (81.7%)
Hypertension † A 179 / 1321 (13.55%)213 / 1317 (16.17%)
†Indicates events were collected by systematic assessment.
ATerm from vocabulary, CTCAE (3.0)
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Certain Agreements:
Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact:
Name/Official Title:
 Rudolf Maibach, Executive Officer for International Trial Activities
Organization:
 IBCSG
Phone:
 +41 31 389 91 96
Email:
 rudolf.maibach@ibcsg.org
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