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

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Tamoxifen

• Registration Number: NCT00201851
• Lead Sponsor: International Breast Cancer Research Foundation

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

Not available

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Primary Completion: 2011-12
• Study Completion: 2013-05
• Results First Submitted: 2015-03-31
• Status Verified: 2015-04
• Results First Submitted QC: 2015-04-13
• Last Update Submitted: 2015-04-13
• Results First Posted: 2015-04-29
• Last Update Posted: 2015-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 740

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Scheduled surgery	Tamoxifen	Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen
Immediate surgery	Tamoxifen	Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen
Immediate Surgery - nonrandomized	Tamoxifen	Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization

Primary Outcome Measures

Name	Time	Method
Disease-free Survival	two- to three-year accrual and initial two or more years of follow-up period	5-year disease-free survival

Trial Locations

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

Rizal; 🇵🇭 Manila, Philippines

Santo Toma Hospital; 🇵🇭 Manila, Philippines

Danang General; 🇻🇳 Danang, Vietnam

Hospital K, National Cancer Institute; 🇻🇳 Hanoi, Vietnam

Hue Central; 🇻🇳 Hue, Vietnam