At a glance
ClinicalIndex Comparison Record- ✓Female age 18–50 years
- ✓Premenopausal with regular menstrual cycles (>25–35 days in length)
- ✓Stage II–IIIA hormone receptor–positive invasive breast cancer
- ✓Fine-needle aspiration diagnosis
- ✕Prior radiation therapy
- ✕Prior chemotherapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase III Randomized Study of Immediate Versus Luteal Phase Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-positive Breast Cancer
In Brief
A Phase 3 clinical trial evaluating Tamoxifen and Surgery: Oophorectomy for Breast Cancer. Completed, enrolled 740 participants across 9 sites in 3 countries.
Detailed Summary
This trial tests surgical oophorectomy (removal of ovaries) plus Tamoxifen, done at different times in the menstrual cycle, as adjuvant therapy for invasive breast cancer in 510 premenopausal women with Hormone Receptor-positive Breast Cancer. This study is recruiting at hospitals in Philippines, Vietnam, and Morocco.
Study Details
Timeline
Interventions
20 mg po daily x 5 years
Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)