Title
Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-Positive Breast Cancer
Phase III Randomized Study of Immediate Versus Luteal Phase Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-positive Breast Cancer
Phase
Phase 3Lead Sponsor
International Breast Cancer Research FoundationStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Breast CancerIntervention/Treatment
tamoxifen ...Study Participants
740This 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.
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)
Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen
Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen
Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization
Inclusion Criteria: Open for accrual in Asia only Female age 18-50, premenopausal with regular cycles (>25-35 in length) fine-needle aspiration diagnosis Stage II-IIIA hormone receptor positive invasive breast cancer No prior radiation or chemotherapy Must be surgical candidate for bilateral oophorectomy
| Event Type | Organ System | Event Term | A - Scheduled Surgery | B - Immediate Surgery | C- Immediate Surgery - Nonrandomized |
|---|
5-year disease-free survival
