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NCT00066690 · ClinicalTrials.gov registry record · Phase 3
Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer
A Phase 3 study, sponsored by ETOP IBCSG Partners Foundation.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,066
- Enrollment target
NCT00066690: Completed Phase 3 study, sponsored by ETOP IBCSG Partners Foundation.
NCT00066690 is a Phase 3 study that has completed, run by ETOP IBCSG Partners Foundation. The registered enrollment target is 3,066 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (297% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00066690, a Phase 3 study, has completed, sponsored by ETOP IBCSG Partners Foundation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,066 participants
- Enrollment target
Study Summary
RATIONALE: Estrogen can stimulate the growth of breast tumor cells. Ovarian function suppression combined with hormone therapy using tamoxifen or exemestane may fight breast cancer by reducing the production of estrogen. It is not yet known whether suppression of ovarian function plus either tamoxifen or exemestane is more effective than tamoxifen alone in preventing the recurrence of hormone-responsive breast cancer. PURPOSE: This randomized phase III trial studies ovarian suppression with either tamoxifen or exemestane to see how well they work compared to tamoxifen alone in treating premenopausal women who have undergone surgery for hormone-responsive breast cancer.
Primary Outcome
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.
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Laboratory Biomarker Analysis
- RADIATION Radiation Therapy
- DRUG Exemestane
- PROCEDURE Oophorectomy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,066 participants |
| Start Date | 2003-12-17 |
| Est. Completion | 2024-11-06 |
| Phase | Phase 3 |
What the finished NCT00066690 record still lists
NCT00066690 is an interventional study that assigns participants to a tested intervention. Its 3,066 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (297% higher).
The record links to 0 conditions, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT00066690 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00066690 about?
NCT00066690 is a clinical study titled "Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer". RATIONALE: Estrogen can stimulate the growth of breast tumor cells. Ovarian function suppression combined with hormone therapy using tamoxifen or exemestane may fight breast cancer by reducing the production of estrogen. It is not yet known whether suppression of ovarian function plus either tamoxif...
What is the current status of trial NCT00066690?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,066 participants. The study started on 2003-12-17. Estimated completion is 2024-11-06.
What interventions are being tested in trial NCT00066690?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Laboratory Biomarker Analysis (OTHER), Radiation Therapy (RADIATION), Exemestane (DRUG), Oophorectomy (PROCEDURE).
Who is sponsoring clinical trial NCT00066690?
This trial is sponsored by ETOP IBCSG Partners Foundation, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00066690's enrollment target sits among peer trials
3,066 77th of 2000 higher than 1,924 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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