Conditions: Breast Cancer
Keywords: Asian Premenopausal Women Oophorectomy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 740
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen arm 2: Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen arm 3: Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization

Interventions: intervention 1: Tamoxifen intervention 2: Surgery: Oophorectomy
Intervention descriptions: intervention 1: 20 mg po daily x 5 years intervention 2: 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)

Protocol document: