History of Changes for Study: NCT00066703

Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer

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Study Record Versions

Version	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

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	CDR0000316458
Brief Title:	Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer
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 NABCI-IBCSG-25-02 EU-20347 EUDRACT-2004-000168-28

Study Status


Record Verification:	September 2007
Overall Status:	Recruiting
Study Start:	August 2003
Primary Completion:
Study Completion:

First Submitted:	August 6, 2003
First Submitted that Met QC Criteria:	August 6, 2003
First Posted:	August 7, 2003 [Estimate]

Last Update Submitted that Met QC Criteria:	September 10, 2007
Last Update Posted:	September 12, 2007 [Estimate]

Sponsor/Collaborators


Sponsor:	ETOP IBCSG Partners Foundation
Responsible Party:
Collaborators:	National Cancer Institute (NCI) Breast International Group

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:

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 uptake 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 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.
Compare the sites of first treatment failure in patients treated with these regimens.
Compare the incidence of second (non-breast) malignancies in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, concurrent adjuvant chemotherapy (yes vs no), and number of positive axillary and/or internal mammary lymph nodes (0 vs 1 or more). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive triptorelin intramuscularly on day 1 every 28 days. Patients in the adjuvant chemotherapy stratum receive chemotherapy concurrently with triptorelin for at least 2 months (if anthracycline is included) or at least 4 months (if no anthracycline is included). Beginning after the completion of chemotherapy or approximately 6-8 weeks after the initiation of triptorelin, patients receive oral tamoxifen daily.
Arm II: Patients receive triptorelin as in arm I. Beginning after the completion of adjuvant chemotherapy or approximately 6-8 weeks after the initiation of triptorelin, patients also receive oral exemestane daily.

In both arms, treatment continues for 5 years in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every 6 months for 2 years, and annually for 3 years.

Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,845 patients will be accrued for this study within 4.5 years.

Conditions


Conditions:	Breast Cancer
Keywords:	stage I breast cancer stage II breast cancer stage IIIA breast cancer

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:
Number of Arms:
Masking:	(masked roles unspecified)
Allocation:	Randomized
Enrollment:	1845

Arms and Interventions


Intervention Details:
	Drug: exemestane
	Drug: tamoxifen citrate
	Drug: triptorelin
	Procedure: adjuvant therapy
	Procedure: antiestrogen therapy
	Procedure: antiprogestational therapy
	Procedure: aromatase inhibition
	Procedure: endocrine therapy
	Procedure: hormone therapy
	Procedure: releasing hormone agonist therapy

Outcome Measures


Primary Outcome Measures:
1.	Disease-free survival
Secondary Outcome Measures:
1.	Overall survival
2.	Systemic disease-free survival
3.	Quality of life
4.	Sites of first recurrence
5.	Late side effects of early menopause
6.	Causes of death without recurrence
7.	Incidence of second (nonbreast) malignancies

Eligibility


Minimum Age:
Maximum Age:
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

Contacts/Locations


Study Officials:	Olivia Pagani, MD Study Chair Ospedale Beata Vergine
Locations:	United States, Arkansas
	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences [Recruiting] Little Rock, Arkansas, United States, 72205 Contact:Contact: Clinical Trial Office - Arkansas Cancer Research Center at Uni 501-686-8274
	United States, California
	Providence Saint Joseph Medical Center - Burbank [Recruiting] Burbank, California, United States, 91505 Contact:Contact: Clinical Trials Office - Providence Saint Joseph Medical Cente 818-847-3220
	Moores UCSD Cancer Center [Recruiting] La Jolla, California, United States, 92093-0658 Contact:Contact: Clinical Trials Office - Moores UCSD Cancer Center 858-822-5354 cancercto@ucsd.edu
	USC/Norris Comprehensive Cancer Center and Hospital [Recruiting] Los Angeles, California, United States, 90089-9181 Contact:Contact: Clinical Trials Office - USC/Norris Comprehensive Cancer Cente 323-865-0451
	Desert Regional Medical Center Comprehensive Cancer Center [Recruiting] Palm Springs, California, United States, 92262 Contact:Contact: Clinical Trials Office - Desert Regional Medical Center Compre 760-416-4730
	Mercy General Hospital [Recruiting] Sacramento, California, United States, 95819 Contact:Contact: Mansoor Javeed 916-453-4453
	San Francisco General Hospital Medical Center [Recruiting] San Francisco, California, United States, 94110 Contact:Contact: Hope S. Rugo, MD 415-353-7428
	UCSF Comprehensive Cancer Center [Recruiting] San Francisco, California, United States, 94115 Contact:Contact: Clinical Trials Office - UCSF Comprehensive Cancer Center 877-827-3222
	Ruby L. Golleher Cancer Program at Presbyterian Intercommunity Hospital [Recruiting] Whittier, California, United States, 90602 Contact:Contact: Jack H. Freimann, MD 562-698-0811
	United States, Colorado
	University of Colorado Cancer Center at UC Health Sciences Center [Recruiting] Aurora, Colorado, United States, 80045 Contact:Contact: Clinical Trials Office - University of Colorado Cancer Center 720-848-0650
	United States, Connecticut
	Middlesex Hospital Cancer Center [Recruiting] Middletown, Connecticut, United States, 06457 Contact:Contact: Mark J. Kimmel, MD 860-358-2220
	United States, District of Columbia
	Walter Reed Army Medical Center [Recruiting] Washington, District of Columbia, United States, 20307-5001 Contact:Contact: Clinical Trials Office - Walter Reed Army Medical Center 202-782-7840
	United States, Florida
	Mayo Clinic - Jacksonville [Recruiting] Jacksonville, Florida, United States, 32224 Contact:Contact: Clinical Trials Office - Mayo Clinic - Jacksonville 507-538-7623
	University of Miami Sylvester Comprehensive Cancer Center - Miami [Recruiting] Miami, Florida, United States, 33136 Contact:Contact: University of Miami Sylvester Comprehensive Cancer Center Clin 866-574-5124 Sylvester@emergingmed.com
	United States, Georgia
	Northeast Georgia Medical Center [Recruiting] Gainesville, Georgia, United States, 30501 Contact:Contact: Richard J. LoCicero, MD 770-535-3553
	Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler [Recruiting] Savannah, Georgia, United States, 31405 Contact:Contact: Mark A. Taylor, MD 912-819-6194voicemail
	United States, Idaho
	St. Luke's Mountain States Tumor Institute - Boise [Recruiting] Boise, Idaho, United States, 83712 Contact:Contact: Theodore A. Walters, MD 208-381-2711
	North Idaho Cancer Center [Recruiting] Coeur d'Alene, Idaho, United States, 83814 Contact:Contact: Clinical Trials Office - North Idaho Cancer Center 208-666-3764
	United States, Illinois
	John H. Stroger, Jr. Hospital of Cook County [Recruiting] Chicago, Illinois, United States, 60612-3785 Contact:Contact: Howard A. Zaren, MD, FACS 312-864-3200
	University of Chicago Cancer Research Center [Recruiting] Chicago, Illinois, United States, 60637-1470 Contact:Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424
	Evanston Northwestern Healthcare - Evanston Hospital [Recruiting] Evanston, Illinois, United States, 60201-1781 Contact:Contact: Clinical Trials Office - Evanston Northwestern Healthcare - Ev 847-570-1381
	United States, Indiana
	Elkhart General Hospital [Recruiting] Elkhart, Indiana, United States, 46515 Contact:Contact: Rafat H. Ansari, MD, FACP 574-234-5123
	Fort Wayne Medical Oncology and Hematology [Recruiting] Fort Wayne, Indiana, United States, 46815 Contact:Contact: Sreenivasa R. Nattam, MD 260-484-8830
	Center for Cancer Therapy at LaPorte Hospital and Health Services [Recruiting] La Porte, Indiana, United States, 46350 Contact:Contact: Rafat H. Ansari, MD, FACP 574-234-5123
	CCOP - Northern Indiana CR Consortium [Recruiting] South Bend, Indiana, United States, 46601 Contact:Contact: Rafat H. Ansari, MD, FACP 574-234-5123
	Memorial Hospital of South Bend [Recruiting] South Bend, Indiana, United States, 46601 Contact:Contact: Clinical Trials Office - Memorial Hospital of South Bend 800-284-7370
	United States, Iowa
	Hematology Oncology Associates of the Quad Cities [Recruiting] Bettendorf, Iowa, United States, 52722 Contact:Contact: Shobha R. Chitneni, MD, MBBS 563-355-7733
	Siouxland Hematology-Oncology Associates, LLP [Recruiting] Sioux City, Iowa, United States, 51101 Contact:Contact: Donald B. Wender, MD, PhD 712-252-9326
	Cedar Valley Medical Specialists, PC - West Ridgeway Avenue [Recruiting] Waterloo, Iowa, United States, 50702 Contact:Contact: Joginder Joe Singh, MD 319-272-2700
	United States, Kansas
	Cancer Center of Kansas, PA - Chanute [Recruiting] Chanute, Kansas, United States, 66720 Contact:Contact: Shaker R. Dakhil, MD, FACP 316-262-4467
	Cancer Center of Kansas, PA - Dodge City [Recruiting] Dodge City, Kansas, United States, 67801 Contact:Contact: Shaker R. Dakhil, MD, FACP 316-262-4467
	Cancer Center of Kansas, PA - Kingman [Recruiting] Kingman, Kansas, United States, 67068 Contact:Contact: Shaker R. Dakhil, MD, FACP 316-262-4467
	Southwest Medical Center [Recruiting] Liberal, Kansas, United States, 67901 Contact:Contact: Shaker R. Dakhil, MD, FACP 316-262-4467
	Cancer Center of Kansas, PA - Newton [Recruiting] Newton, Kansas, United States, 67114 Contact:Contact: Shaker R. Dakhil, MD, FACP 316-262-4467
	Cancer Center of Kansas, PA - Salina [Recruiting] Salina, Kansas, United States, 67042 Contact:Contact: Shaker R. Dakhil, MD, FACP 316-262-4467
	Cotton-O'Neil Cancer Center [Recruiting] Topeka, Kansas, United States, 66604 Contact:Contact: Stanley J. Vogel, MD 785-354-0544
	Cancer Center of Kansas, PA - Wellington [Recruiting] Wellington, Kansas, United States, 67152 Contact:Contact: Shaker R. Dakhil, MD, FACP 316-262-4467
	Associates in Womens Health, PA - North Review [Recruiting] Wichita, Kansas, United States, 67203 Contact:Contact: Shaker R. Dakhil, MD, FACP 316-262-4467
	Cancer Center of Kansas, PA - Medical Arts Tower [Recruiting] Wichita, Kansas, United States, 67208 Contact:Contact: Shaker R. Dakhil, MD, FACP 316-262-4467
	Cancer Center of Kansas, PA - Wichita [Recruiting] Wichita, Kansas, United States, 67214 Contact:Contact: Shaker R. Dakhil, MD, FACP 316-262-4467
	CCOP - Wichita [Recruiting] Wichita, Kansas, United States, 67214 Contact:Contact: Shaker R. Dakhil, MD, FACP 316-262-4467
	Via Christi Cancer Center at Via Christi Regional Medical Center [Recruiting] Wichita, Kansas, United States, 67214 Contact:Contact: Shaker R. Dakhil, MD, FACP 316-262-4467
	Cancer Center of Kansas, PA - Winfield [Recruiting] Winfield, Kansas, United States, 67156 Contact:Contact: Shaker R. Dakhil, MD, FACP 316-262-4467
	United States, Maine
	Central Maine Comprehensive Cancer Center at Central Maine Medical Center [Recruiting] Lewiston, Maine, United States, 04240 Contact:Contact: Nicholette Erickson, MD 207-795-2440
	United States, Maryland
	Greenebaum Cancer Center at University of Maryland Medical Center [Recruiting] Baltimore, Maryland, United States, 21201 Contact:Contact: Clinical Trials Office - Greenebaum Cancer Center at Universit 800-888-8823
	Mercy Medical Center [Recruiting] Baltimore, Maryland, United States, 21202 Contact:Contact: David A. Riseberg, MD 410-783-5858
	Suburban Hospital [Recruiting] Bethesda, Maryland, United States, 20814 Contact:Contact: Carolyn B. Hendricks, MD 301-897-1503
	Frederick Memorial Hospital Regional Cancer Therapy Center [Recruiting] Frederick, Maryland, United States, 21701 Contact:Contact: Elhamy Eskander, MD, FACP 301-662-8477
	United States, Massachusetts
	Massachusetts General Hospital [Recruiting] Boston, Massachusetts, United States, 02114 Contact:Contact: Clinical Trials Office - Massachusetts General Hospital 877-726-5130
	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute [Recruiting] Boston, Massachusetts, United States, 02115 Contact:Contact: Clinical Trials Office - Dana-Farber/Harvard Cancer Center at 617-582-8480
	Beth Israel Deaconess Medical Center [Recruiting] Boston, Massachusetts, United States, 02215 Contact:Contact: Clinical Trials Office - Beth Israel Deaconess Medical Center 617-667-9925
	Bethke Cancer Center at Emerson Hospital [Recruiting] Concord, Massachusetts, United States, 01742 Contact:Contact: Clinical Trials Office - Bethke Cancer Center at Emerson Hospi 978-287-3460
	Addison Gilbert Hospital [Recruiting] Gloucester, Massachusetts, United States, 01930 Contact:Contact: Angus P. McIntyre, MD 978-281-6460
	Cape Cod Hospital [Recruiting] Hyannis, Massachusetts, United States, 02601 Contact:Contact: David R. Lovett, MD 508-771-1800
	Lowell General Hospital [Recruiting] Lowell, Massachusetts, United States, 01854 Contact:Contact: Blair Ardman, MD 978-934-8425
	NSMC Cancer Center - Peabody [Recruiting] Peabody, Massachusetts, United States, 01960 Contact:Contact: Karen Krag, MD 978-977-3434
	United States, Michigan
	Saint Joseph Mercy Cancer Center [Recruiting] Ann Arbor, Michigan, United States, 48106-0995 Contact:Contact: Philip J. Stella, MD 734-712-5658
	William Beaumont Hospital - Royal Oak Campus [Recruiting] Royal Oak, Michigan, United States, 48073 Contact:Contact: Clinical Trials Office - William Beaumont Hospital - Royal Oak 248-551-7695
	Lakeland Regional Cancer Care Center - St. Joseph [Recruiting] St. Joseph, Michigan, United States, 49085 Contact:Contact: Rafat H. Ansari, MD, FACP 574-234-5123
	United States, Minnesota
	Fairview Ridges Hospital [Recruiting] Burnsville, Minnesota, United States, 55337 Contact:Contact: Patrick J. Flynn, MD 612-863-8585
	Mercy and Unity Cancer Center at Mercy Hospital [Recruiting] Coon Rapids, Minnesota, United States, 55433 Contact:Contact: Patrick J. Flynn, MD 612-863-8585
	Fairview Southdale Hospital [Recruiting] Edina, Minnesota, United States, 55435 Contact:Contact: Clinical Trials Office - Fairview Southdale Hospital 612-625-3650
	Mercy and Unity Cancer Center at Unity Hospital [Recruiting] Fridley, Minnesota, United States, 55432 Contact:Contact: Patrick J. Flynn, MD 612-863-8585
	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital [Recruiting] Minneapolis, Minnesota, United States, 55407 Contact:Contact: Clinical Trials Office - Virginia Piper Cancer Institute 612-863-5654
	Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center [Recruiting] Robbinsdale, Minnesota, United States, 55422-2900 Contact:Contact: Clinical Trials Office - Hubert H. Humphrey Cancer Center at N 763-520-1893
	Mayo Clinic Cancer Center [Recruiting] Rochester, Minnesota, United States, 55905 Contact:Contact: Clinical Trials Office - Mayo Clinic Cancer Center 507-538-7623
	CCOP - Metro-Minnesota [Recruiting] Saint Louis Park, Minnesota, United States, 55416 Contact:Contact: Patrick J. Flynn, MD 612-863-8585
	Park Nicollet Cancer Center [Recruiting] St. Louis Park, Minnesota, United States, 55416 Contact:Contact: Patrick J. Flynn, MD 612-863-8585
	United Hospital [Recruiting] St. Paul, Minnesota, United States, 55102 Contact:Contact: Patrick J. Flynn, MD 612-863-8585
	Ridgeview Medical Center [Recruiting] Waconia, Minnesota, United States, 55387 Contact:Contact: Patrick J. Flynn, MD 612-863-8585
	United States, Missouri
	Saint Louis University Cancer Center [Recruiting] Saint Louis, Missouri, United States, 63110 Contact:Contact: Clinical Trials Office - Saint Louis University Cancer Center 314-977-4440
	St. John's Regional Health Center [Recruiting] Springfield, Missouri, United States, 65804 Contact:Contact: John W. Goodwin, MD 417-889-8099
	Hulston Cancer Center at Cox Medical Center South [Recruiting] Springfield, Missouri, United States, 65807 Contact:Contact: John W. Goodwin, MD 417-889-8099
	Siteman Cancer Center at Barnes-Jewish Hospital [Recruiting] St Louis, Missouri, United States, 63110 Contact:Contact: Michael J. Naughton, MD 314-747-7222
	United States, Montana
	CCOP - Montana Cancer Consortium [Recruiting] Billings, Montana, United States, 59101 Contact:Contact: Benjamin T. Marchello, MD 406-259-2245
	Billings Clinic - Downtown [Recruiting] Billings, Montana, United States, 59107-7000 Contact:Contact: Clinical Trials Office - Billings Clinic - Downtown 800-996-2663 research@billingsclinic.org
	Big Sky Oncology [Recruiting] Great Falls, Montana, United States, 59405-5309 Contact:Contact: Clinical Trail Office - Big Sky Oncology 406-731-8217
	Great Falls Clinic - Main Facility [Recruiting] Great Falls, Montana, United States, 59405 Contact:Contact: Benjamin T. Marchello, MD 406-454-2171
	United States, Nebraska
	Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center [Recruiting] Grand Island, Nebraska, United States, 68803 Contact:Contact: Elizabeth C. Reed, MD 402-559-5520
	Good Samaritan Cancer Center at Good Samaritan Hospital [Recruiting] Kearney, Nebraska, United States, 68848-1990 Contact:Contact: Clinical Trials Office - Good Samaritan Cancer Center at Good 308-865-7963
	UNMC Eppley Cancer Center at the University of Nebraska Medical Center [Recruiting] Omaha, Nebraska, United States, 68198-6805 Contact:Contact: Clinical Trials Office - UNMC Eppley Cancer Center at the Univ 800-999-5465
	United States, New Jersey
	CCOP - Northern New Jersey [Recruiting] Hackensack, New Jersey, United States, 07601 Contact:Contact: Norman G. Rosenblum, MD, PhD 201-996-5917
	Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton [Recruiting] Marlton, New Jersey, United States, 08053 Contact:Contact: Clinical Trials Office - Fox Chase Virtua Health Cancer Progra 888-847-8823
	Overlook Hospital [Recruiting] Summit, New Jersey, United States, 07902 Contact:Contact: Daniel J. Moriarty, MD 908-608-0078
	Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare [Recruiting] Vineland, New Jersey, United States, 08360 Contact:Contact: Clinical Trials Office - Franklin & Edith Scarpa Regional Canc 856-641-7933
	Fox Chase Virtua Health Cancer Program at Virtua West Jersey [Recruiting] Voorhees, New Jersey, United States, 08043 Contact:Contact: Michael S. Entmacher, MD 800-847-8823
	United States, New York
	Albert Einstein Cancer Center at Albert Einstein College of Medicine [Recruiting] Bronx, New York, United States, 10461 Contact:Contact: Clinical Trials Office - Albert Einstein Cancer Center at Albe 718-904-2730 aecc@aecom.yu.edu
	Our Lady of Mercy Medical Center Comprehensive Cancer Center [Recruiting] Bronx, New York, United States, 10466 Contact:Contact: Peter H. Wiernik, MD 718-304-7200
	Roswell Park Cancer Institute [Recruiting] Buffalo, New York, United States, 14263-0001 Contact:Contact: Clinical Trials Office - Roswell Park Cancer Institute 877-275-7724
	NYU Cancer Institute at New York University Medical Center [Recruiting] New York, New York, United States, 10016 Contact:Contact: Amy D. Tiersten, MD 212-263-6485
	United States, North Carolina
	Randolph Hospital [Recruiting] Asheboro, North Carolina, United States, 27203-5400 Contact:Contact: Clinical Trails Office - Randolph Hospital 336-832-0821
	Hope A Women's Cancer Center [Recruiting] Asheville, North Carolina, United States, 28801 Contact:Contact: David J. Hetzel, MD 828-670-8403
	Mission Hospitals - Memorial Campus [Recruiting] Asheville, North Carolina, United States, 28801 Contact:Contact: Clinical Trials Office - Mission Hospitals - Memorial Campus 828-213-4150
	Wayne Memorial Hospital, Incorporated [Recruiting] Goldsboro, North Carolina, United States, 27534 Contact:Contact: James N. Atkins, MD 919-580-0000
	Moses Cone Regional Cancer Center at Wesley Long Community Hospital [Recruiting] Greensboro, North Carolina, United States, 27403-1198 Contact:Contact: Clinical Trials Office - Moses Cone Regional Cancer Center at 336-621-8374
	Pardee Memorial Hospital [Recruiting] Hendersonville, North Carolina, United States, 28791 Contact:Contact: James E. Radford, MD 828-692-8045
	Kinston Medical Specialists [Recruiting] Kinston, North Carolina, United States, 28501 Contact:Contact: Peter R. Watson, MD 252-559-2200 ext. 201
	Annie Penn Cancer Center [Recruiting] Reidsville, North Carolina, United States, 27320 Contact:Contact: Clinical Trials Office - Annie Penn Cancer Center 336-621-8374
	Forsyth Regional Cancer Center at Forsyth Medical Center [Recruiting] Winston-Salem, North Carolina, United States, 27103 Contact:Contact: Clinical Trials Office - Forsyth Regional Cancer Center at For 336-277-8887
	United States, North Dakota
	Medcenter One Hospital Cancer Care Center [Recruiting] Bismarck, North Dakota, United States, 58501 Contact:Contact: Edward J. Wos, DO 701-323-5741
	Dakota Cancer Institute at Dakota Clinic - South University [Recruiting] Fargo, North Dakota, United States, 58103 Contact:Contact: Mahendra K. Gupta 701-364-8910
	Trinity CancerCare Center [Recruiting] Minot, North Dakota, United States, 58701 Contact:Contact: Paul H. Freiberg, MD 701-852-0719
	United States, Ohio
	Aultman Cancer Center at Aultman Hospital [Recruiting] Canton, Ohio, United States, 44710-1799 Contact:Contact: Clinical Trials Office - Aultman Cancer Center at Aultman Hosp 330-363-6891
	MetroHealth Cancer Care Center at MetroHealth Medical Center [Recruiting] Cleveland, Ohio, United States, 44109 Contact:Contact: Bruce J. Averbook, MD, FACS 216-778-4795
	United States, Pennsylvania
	Geisinger Medical Center [Recruiting] Danville, Pennsylvania, United States, 17822-0001 Contact:Contact: Clinical Trials Office - Geisinger Medical Center 570-271-5251
	Geisinger Medical Group - Scenery Park [Recruiting] State College, Pennsylvania, United States, 16801 Contact:Contact: Albert M. Bernath, MD 814-231-4560
	Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center [Recruiting] Wilkes-Barre, Pennsylvania, United States, 18711 Contact:Contact: Clinical Trials Office - Frank M. and Dorothea Henry Cancer Ce 570-271-5251
	United States, South Carolina
	Hollings Cancer Center at Medical University of South Carolina [Recruiting] Charleston, South Carolina, United States, 29425 Contact:Contact: Clinical Trials Office - Hollings Cancer Center at Medical Uni 843-792-9321
	CCOP - Greenville [Recruiting] Greenville, South Carolina, United States, 29615 Contact:Contact: Jeffrey K. Giguere, MD, FACP 864-241-6251
	United States, South Dakota
	Avera Cancer Institute [Recruiting] Sioux Falls, South Dakota, United States, 57105 Contact:Contact: Loren K. Tschetter, MD 605-328-8000
	Sanford Cancer Center at Sanford USD Medical Center [Recruiting] Sioux Falls, South Dakota, United States, 57117-5039 Contact:Contact: Clinical Trials Office - Sanford Cancer Center at Sanford USD 605-328-1367
	United States, Tennessee
	Erlanger Cancer Center at Erlanger Hospital - Baroness [Recruiting] Chattanooga, Tennessee, United States, 37403 Contact:Contact: Clinical Trials Office - Erlanger Cancer Center at Erlanger Ho 423-778-6947
	Baptist Hospital [Recruiting] Nashville, Tennessee, United States, 37236 Contact:Contact: Pat W. Whitworth, MD 615-284-7300
	United States, Texas
	St. Joseph Regional Cancer Center [Recruiting] Bryan, Texas, United States, 77802 Contact:Contact: Usha Venkatraj, MD 979-774-0900
	United States, Vermont
	Mountainview Medical [Recruiting] Berlin, Vermont, United States, 05602 Contact:Contact: Susan Burdette-Radoux, MD 802-847-3827
	Fletcher Allen Health Care - University Health Center Campus [Recruiting] Burlington, Vermont, United States, 05401 Contact:Contact: Clinical Trials Office - Fletcher Allen Health Care 802-656-8990
	United States, Virginia
	Danville Regional Medical Center [Recruiting] Danville, Virginia, United States, 24541 Contact:Contact: Clinical Trials Office - Danville Regional Medical Center 434-799-3753
	United States, Washington
	St. Joseph Cancer Center [Recruiting] Bellingham, Washington, United States, 98225 Contact:Contact: Saul E. Rivkin, MD 206-386-2929
	Group Health Central Hospital [Recruiting] Seattle, Washington, United States, 98112 Contact:Contact: Clinical Trials Office - Group Health Central Hospital 206-287-2900
	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus [Recruiting] Seattle, Washington, United States, 98122-4307 Contact:Contact: Saul E. Rivkin, MD 206-386-2929
	University Cancer Center at University of Washington Medical Center [Recruiting] Seattle, Washington, United States, 98195-6043 Contact:Contact: Clinical Trials Office - University Cancer Center at Universit 206-616-8289
	Cancer Care Northwest - Spokane South [Recruiting] Spokane, Washington, United States, 99202 Contact:Contact: Clinical Trials Office - Cancer Care Northwest - Spokane South 509-228-1083
	Madigan Army Medical Center - Tacoma [Recruiting] Tacoma, Washington, United States, 98431 Contact:Contact: David E. McCune, MD 253-968-2504
	United States, West Virginia
	Mary Babb Randolph Cancer Center at West Virginia University Hospitals [Recruiting] Morgantown, West Virginia, United States, 26506 Contact:Contact: Jame Abraham, MD 304-293-4229
	United States, Wisconsin
	Oncology Alliance, SC - Milwaukee - East [Recruiting] Glendale, Wisconsin, United States, 53212-1038 Contact:Contact: Clinical Trials Office - Oncology Alliance, SC - Milwaukee - E 414-906-4480
	University of Wisconcin Cancer Center at Aspirus Wausau Hospital [Recruiting] Wausau, Wisconsin, United States, 54401 Contact:Contact: Clinical Trials Office - University of Wisconsin Cancer Center 608-262-5223
	Australia, New South Wales
	Cancer Therapy Centre at Campbelltown Hospital [Recruiting] Campbelltown, New South Wales, Australia, 2560 Contact:Contact: Stephen Della-Fiorentina, MD 61-24-634-4355
	Belgium
	Centre Hospitalier Hutois [Recruiting] Huy, Belgium, 4500 Contact:Contact: Joelle Collignon, MD 32-8527-2111
	U.Z. Gasthuisberg [Recruiting] Leuven, Belgium, B-3000 Contact:Contact: Patrick Neven, MD 32-1634-4213
	CHU Liege - Domaine Universitaire du Sart Tilman [Recruiting] Liege, Belgium, B-4000 Contact:Contact: Guy Jerusalem, MD, PhD 32-4-366-7111 g.jerusalem@chu.ulg.ac.be
	Centre Hospitalier Peltzer-La Tourelle [Recruiting] Verviers, Belgium, B-4800 Contact:Contact: Jean Paul Salmon, MD 32-87-212-111
	Brazil, Rio Grande do Sul
	Hospital de Clinicas de Porto Alegre [Recruiting] Porto Alegre, Rio Grande do Sul, Brazil, 90035-003 Contact:Contact: Carlos H. Menke, MD, PhD 55-51-2101-8232 menke@hcpa.ufrgs.br
	Canada, Alberta
	Tom Baker Cancer Centre - Calgary [Recruiting] Calgary, Alberta, Canada, T2N 4N2 Contact:Contact: Barbara A. Walley, MD, FRCPC 403-944-1013
	Cross Cancer Institute at University of Alberta [Recruiting] Edmonton, Alberta, Canada, T6G 1Z2 Contact:Contact: Katia S. Tonkin, MD 780-432-8771
	Canada, New Brunswick
	Saint John Regional Hospital [Recruiting] Saint John, New Brunswick, Canada, E2L 4L2 Contact:Contact: Margot J. Burnell, MD 506-648-6884
	Canada, Ontario
	Margaret and Charles Juravinski Cancer Centre [Recruiting] Hamilton, Ontario, Canada, L8V 5C2 Contact:Contact: Richard Tozer, MD, PhD 905-387-9495ext64604
	London Regional Cancer Program at London Health Sciences Centre [Recruiting] London, Ontario, Canada, N6A 4L6 Contact:Contact: Kylea R. Potvin 519-685-8600
	Trillium Health Centre - Mississauga Site [Recruiting] Mississauga, Ontario, Canada, L5B 1B8 Contact:Contact: John A.P. Gapski, MD 905-270-3842
	Windsor Regional Cancer Centre at Windsor Regional Hospital [Recruiting] Windsor, Ontario, Canada, N8W 2X3 Contact:Contact: Caroline M. Hamm, MD 519-253-5253
	Canada, Quebec
	Hopital Charles Lemoyne [Recruiting] Greenfield Park, Quebec, Canada, J4V 2H1 Contact:Contact: Catherine Prady, MD 450-466-5000ext3376
	Hopital Du Sacre-Coeur de Montreal [Recruiting] Montreal, Quebec, Canada, H4J 1C5 Contact:Contact: Josee-Anne Roy, MD 514-338-2150
	Canada, Saskatchewan
	Allan Blair Cancer Centre at Pasqua Hospital [Recruiting] Regina, Saskatchewan, Canada, S4T 7T1 Contact:Contact: Muhammad Salim, MD 306-766-2203
	Saskatoon Cancer Centre at the University of Saskatchewan [Recruiting] Saskatoon, Saskatchewan, Canada, S7N 4H4 Contact:Contact: Amer Sami, MD 306-655-2710
	Egypt
	National Cancer Institute of Egypt [Recruiting] Cairo, Egypt Contact:Contact: Hussein M. Khaled, MD 20-2-215-1040 khaled@internetegypt.com
	Germany
	Caritas - Krankenhaus Saint Josef [Recruiting] Regensburg, Germany, 93053 Contact:Contact: B. Westhauser 49-941-782-7511
	Hungary
	National Institute of Oncology [Recruiting] Budapest, Hungary, 1122 Contact:Contact: Istvan Lang, MD, PhD, DSc 36-1-22-48-763 lang@oncol.hu
	India
	Tata Memorial Hospital [Recruiting] Mumbai, India, 400012 Contact:Contact: Vani Parmar 91-22-2417-7194
	Italy
	Centro di Riferimento Oncologico - Aviano [Recruiting] Aviano, Italy, 33081 Contact:Contact: Diana Crivellari, MD 39-0434-659-024 dcrivellari@oro.it
	Ospedali Riuniti di Bergamo [Recruiting] Bergamo, Italy, 24100 Contact:Contact: Carlo Tondini, MD 39-03-526-6424 carlo.tondoni@ospedaliriuniti.bergamo.it
	Azienda Sanitaria di Bolzano [Recruiting] Bolzano, Italy, 39100 Contact:Contact: Claudio Graiff, MD 39-0471-908-572 claudio.graiff@asbz.it
	Spedali Civili di Brescia [Recruiting] Brescia, Italy, 25124 Contact:Contact: Edda Simoncini, MD 39-030-3995-410
	Ospedale Civile Ramazzini [Recruiting] Carpi, Italy, 41012 Contact:Contact: Fabrizio Artioli, MD 39-059-659-313 f.artioli@ausl.mo.it
	European Institute of Oncology [Recruiting] Milan, Italy, 20141 Contact:Contact: Aron Goldhirsch, MD 39-02-574-894-39 aron.goldhirsch@ibcsg.org
	Fondazione Salvatore Maugeri [Recruiting] Pavia, Italy, I-27100 Contact:Contact: Lorenzo Pavesi 39-382-592-669
	Misericordia e Dolce Hospital [Recruiting] Prato, Italy, 59100 Contact:Contact: Angelo Di Leo, MD 39-0574-43-4766 adileo@usl4.toscana.it
	Ospedale Civile Rimini [Recruiting] Rimini, Italy, 47900 Contact:Contact: Alberto Ravaioli, MD 39-541-705-409 aravaiol@auslrn.net
	Istituto Clinico Humanitas [Recruiting] Rozzano, Italy, 20089 Contact:Contact: Armando Santoro, MD 39-28-224-4080 armando.santoro@humanitas.it
	Policlinico Universitario [Recruiting] Udine, Italy, 33100 Contact:Contact: Fabio Puglisi 39-4-3255-9304 fabio.puglisi@med.uniud.it
	Ospedale di Circolo e Fondazione Macchi [Recruiting] Varese, Italy, 21100 Contact:Contact: Graziella Pinotti 39-332-278-558
	Peru
	Instituto Nacional de Enfermedades Neoplasicas [Recruiting] Lima, Peru, 34 Contact:Contact: Henry Gomez Moreno 51-1-710-6900
	Slovenia
	Institute of Oncology - Ljubljana [Recruiting] Ljubljana, Slovenia, Sl-1000 Contact:Contact: Bojana Pajk, MD 386-1-5879-535
	South Africa
	Sandton Oncology Centre [Recruiting] Johannesburg, South Africa, 2121 Contact:Contact: Daniel A. Vorobiof, MD 27-11-883-0900 voro@global.co.za
	Sweden
	Sahlgrenska University Hospital [Recruiting] Gothenburg, Sweden, S-413 45 Contact:Contact: Per Karlsson, MD 46-31-342-1000
	University Hospital of Linkoping [Recruiting] Linkoping, Sweden, S-581 85 Contact:Contact: Barbro Linderholm 46-13-222-000
	Skaraborgs Hospital [Recruiting] Skovde, Sweden, 541 85 Contact:Contact: Anders Nissborg, MD 46-500-431-000
	Switzerland
	Universitaetsspital-Basel [Recruiting] Basel, Switzerland, CH-4031 Contact:Contact: Christoph Rochlitz, MD 41-61-265-5059 crochlitz@uhbs.ch
	Oncology Institute of Southern Switzerland [Recruiting] Bellinzona, Switzerland, CH-6500 Contact:Contact: Olivia Pagani, MD 41-91-820-9111 olivia.pagani@ibcsg.org
	Inselspital Bern [Recruiting] Bern, Switzerland, CH-3010 Contact:Contact: Stefan Aebi, MD 41-31-632-4114 stefan.aebi@insel.ch
	Oncocare Sonnenhof-Klinik Engeriedspital [Recruiting] Bern, Switzerland, CH-3012 Contact:Contact: Katharina S. Buser, MD 41-31-309-9501 kbuser@sonnenhof.ch
	Kantonsspital Graubuenden [Recruiting] Chur, Switzerland, CH-7000 Contact:Contact: Roger von Moos, MD 41-81-256-6644 roger.vonmoos@ksgr.ch
	Onkologie-Praxis ZeTup Chur [Recruiting] Chur, Switzerland, CH-7000 Contact:Contact: Hans-Joerg Senn, MD, PhD 44-81-257-0130
	Centre Hospitalier Universitaire Vaudois [Recruiting] Lausanne, Switzerland, 1011 Contact:Contact: Khalil Zaman 41-21-314-0150
	Ospedale "la Carita", Locarno [Recruiting] Locarno, Switzerland, 6600 Contact:Contact: Olivia Pagani, MD 41-91-811-3111
	Ospedale Civico [Recruiting] Lugano, Switzerland, CH-6903 Contact:Contact: Olivia Pagani, MD 41-91-811-3111
	Ospedale Beata Vergine [Recruiting] Mendrisio, Switzerland, CH-6850 Contact:Contact: Olivia Pagani, MD 41-91-811-3395
	Kantonsspital - St. Gallen [Recruiting] St. Gallen, Switzerland, CH-9007 Contact:Contact: Beat Thurlimann, MD 41-71-494-1888 beat.thuerlimann@kssg.ch
	Regionalspital [Recruiting] Thun, Switzerland, 3600 Contact:Contact: Jean Marc Luthi, MD 41-33-226-2626
	UniversitaetsSpital Zuerich [Recruiting] Zurich, Switzerland, CH-8091 Contact:Contact: Stephanie Von Orelli, MD 41-44-255-5313

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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.
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