Clinical trial
Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared…
NCT00066690 · ETOP IBCSG Partners Foundation, Other · Completed
Key facts
| NCT number | NCT00066690 |
|---|---|
| Title | Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer |
| Official title | A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women With Endocrine Responsive Breast Cancer |
| Acronym | SOFT |
| Lead sponsor | ETOP IBCSG Partners Foundation, Other |
| Collaborators | Breast International Group Cancer and Leukemia Group B National Cancer Institute (NCI) NIH NSABP Foundation Inc NCIC Clinical Trials Group North Central Cancer Treatment Group SWOG Cancer Research… |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Estrogen Receptor Positive Breast Cancer, Progesterone Receptor Positive Tumor, Recurrent Breast Carcinoma, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIA Breast Cancer |
| Intervention type | Drug, Other, Procedure, Radiation |
| Interventions | Exemestane, Laboratory Biomarker Analysis, Oophorectomy, Quality-of-Life Assessment, Radiation Therapy, Tamoxifen, Triptorelin |
| Enrollment | 3,066 |
| Start date | Dec 17, 2003 |
| Primary completion | May 1, 2014 |
| Completion | Nov 6, 2024 |
| First posted | Aug 7, 2003 |
| Last update posted | Feb 6, 2026 |
| Countries | Canada, Switzerland, United States |
At a glance
- 100–999 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: