At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 249 enrolled
Drug / intervention
Tamoxifen +1 moredrug
Likely dose
Tamoxifen 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase III Randomized Study of Luteal Phase vs. Follicular Phase Surgical Oophorectomy and Tamoxifen in Premenopausal Women With Metastatic Hormone Receptor-Positive Breast Cancer
International Breast Cancer Research Foundation·interventional·Posted Feb 17, 2006·Updated Jul 27, 2016
In Brief
A Phase 3 clinical trial evaluating oophorectomy and Tamoxifen for Breast Cancer. Completed, enrolled 249 participants across 21 sites in 10 countries.
Detailed Summary
This study will determine if hormone receptor positive premenopausal metastatic breast cancer patients who undergo removal of the ovaries in mid-luteal versus mid-follicular phase have a longer survival.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesBangladesh, China, India, Indonesia, Malaysia, Morocco, Nigeria, Philippines, United States, Vietnam
CollaboratorsBreast Cancer Research Foundation
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2006
First PostedFeb 2006
Primary CompletionFeb 2014
Study CompletionMar 2015
TodayJul 2026
First PostedFeb 17, 2006
Enrollment StartFeb 1, 2006
Primary CompletionFeb 1, 2014
Study CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 8 yearsPosted 20.4 years ago
Interventions
oophorectomyprocedure
Excision of an ovary
Tamoxifendrug
20 mg orally every day