Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-Positive Breast Cancer

Phase 3CompletedNCT00201851

International Breast Cancer Research Foundation740 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

740

Conditions

Breast Cancer

Interventions

TamoxifenDRUG

20 mg po daily x 5 years

Surgery: OophorectomyPROCEDURE

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)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (9)

National Institute of Oncology

Rabat, Morocco

Vicente Soto Memorial Medical Center

Cebu, Philippines

East Avenue Medical Center

Manila, Philippines

Philippine General Hospital

Manila, Philippines

Outcomes

Primary Outcomes

Disease-free Survival

5-year disease-free survival

Time frame: two- to three-year accrual and initial two or more years of follow-up period

Data from ClinicalTrials.gov

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