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

Study Overview
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Brief Summary
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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.

Official Title
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Phase III Randomized Study of Immediate Versus Luteal Phase Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-positive Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Tamoxifen
* Procedure: Surgery: Oophorectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Immediate surgery<br>Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen | Drug: Tamoxifen<br>* 20 mg po daily x 5 years<br>* Other names: Nolvadex®;Procedure: Surgery: Oophorectomy<br>* 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)<br>* Other names: ovary removal surgery;|
| Experimental: Scheduled surgery<br>Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen | Drug: Tamoxifen<br>* 20 mg po daily x 5 years<br>* Other names: Nolvadex®;Procedure: Surgery: Oophorectomy<br>* 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)<br>* Other names: ovary removal surgery;|
| Other: Immediate Surgery - nonrandomized<br>Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization | Drug: Tamoxifen<br>* 20 mg po daily x 5 years<br>* Other names: Nolvadex®;Procedure: Surgery: Oophorectomy<br>* 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)<br>* Other names: ovary removal surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free Survival | 5-year disease-free survival | two- to three-year accrual and initial two or more years of follow-up period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asian, Premenopausal, Women, Oophorectomy