S0230 Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for Breast Cancer
Breast Cancer, Infertility, Menopausal Symptoms
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring infertility, menopausal symptoms, stage II breast cancer, stage IIIA breast cancer, stage IA breast cancer, stage IB breast cancer, estrogen receptor-negative breast cancer, progesterone receptor-negative breast cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed invasive breast cancer Stage I-IIIA Operable disease Bilateral synchronous invasive breast cancer allowed provided primary tumors were diagnosed no more than 1 month apart and both tumors are hormone receptor negative Must be planning to receive 3-8 months of a preoperative or postoperative chemotherapy regimen containing alkylating agents (anthracyclines or non-anthracyclines), meeting 1 of the following criteria: 3-month/4-course anthracycline-based regimen 6- to 8-month/course anthracycline-based regimen 6- to 8-month/course non-anthracycline-based regimen Hormone receptor status: Estrogen receptor negative Progesterone receptor negative PATIENT CHARACTERISTICS: Age 18 to 49 Sex Female Menopausal status Premenopausal Performance status Zubrod 0-2 Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other Not pregnant or nursing Fertile patients must use effective barrier contraception No other prior malignancy except adequately treated basal cell or squamous cell skin cancer or any in situ cancer from which the patient has been disease-free for at least 5 years after treatment with curative intent PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics No prior cytotoxic chemotherapy Endocrine therapy No other concurrent hormonal therapy Radiotherapy Concurrent radiotherapy to the breast, chest wall, or lymph nodes allowed Surgery See Disease Characteristics Other Concurrent participation in other therapeutic clinical trials, including SWOG-S0221, allowed
Sites / Locations
- Mater Hospital - North Sydney
- Royal North Shore Hospital
- Newcastle Mater Misericordiae Hospital
- Royal Adelaide Hospital Cancer Centre
- Flinders Medical Centre
- Royal Hobart Hospital
- Ballarat Oncology and Haematology Services
- Box Hill Hospital
- Monash Medical Center - Clayton Campus
- Peter MacCallum Cancer Centre
- Maroondah Hospital
- St. Vincent's Hospital - Melbourne
- Royal Melbourne Hospital
- Royal Perth Hospital
- Centre Hospitalier Hutois
- U.Z. Gasthuisberg
- Centre Hospitalier Regional de la Citadelle
- CHU Liege - Domaine Universitaire du Sart Tilman
- AZ Damiaan
- Centre Hospitalier Peltzer-La Tourelle
- National Institute of Oncology
- Ospedali Riuniti di Bergamo
- Ospedale degli Infermi - ASL 12
- Ospedale Civile Ramazzini
- Ospedale Alessandro Manzoni
- European Institute of Oncology
- Auckland City Hospital
- Oncology Institute of Southern Switzerland
- Inselspital Bern
- Centre Hospitalier Universitaire Vaudois
- Oncology Institute of Southern Switzerland - Locarno
- Oncology Institute of Southern Switzerland - Lugano
- Oncology Institute of Southern Switzerland - Mendrisio
- Regionalspital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Standard Chemotherapy
Chemotherapy Plus Goserelin
Patients receive cyclophosphamide-containing chemotherapy alone.
Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.