S0230 Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for Breast Cancer
- Conditions
- Breast CancerMenopausal SymptomsInfertility
- Interventions
- Registration Number
- NCT00068601
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
RATIONALE: Goserelin blocks hormone production in the ovaries. It is not yet known whether ovarian suppression using goserelin will prevent ovarian failure (early menopause) in women receiving chemotherapy for breast cancer.
PURPOSE: This randomized phase III trial is studying how well giving goserelin together with chemotherapy works compared with chemotherapy alone in preventing early menopause in women with stage I, stage II, or stage IIIA breast cancer.
- Detailed Description
OBJECTIVES:
Primary
* Compare the rate of premature ovarian failure in women with stage I-IIIA hormone receptor-negative breast cancer treated with chemotherapy with vs without goserelin.
Secondary
* Compare the rate of ovarian dysfunction in patients treated with these regimens.
* Compare ovarian reserve in patients treated with these regimens.
* Describe the pregnancy rates in patients treated with these regimens.
OUTLINE: This is a randomized study. Patients are stratified according to age (under 40 vs 40 to 49) and planned chemotherapy regimen (3- to 4-month/course anthracycline-based vs 6- to 8-month/course anthracycline-based vs 3- to 4-month/course non-anthracycline-based vs 6- to 8-month/course non-anthracycline-based). Patients are randomized to 1 of 2 treatment arms.
* Arm 1: Patients receive cyclophosphamide-containing chemotherapy alone. Patients are followed at 1, 2, and 5 years.
* Arm 2: 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.
PROJECTED ACCRUAL: A total of 416 patients (208 per treatment arm) will be accrued for this study within 3 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 257
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Chemotherapy Plus Goserelin cyclophosphamide 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. Chemotherapy Plus Goserelin goserelin acetate 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. Standard Chemotherapy cyclophosphamide Patients receive cyclophosphamide-containing chemotherapy alone.
- Primary Outcome Measures
Name Time Method Rate of Premature Ovarian Failure at 2 Years 2 years Ovarian failure at two years is defined as amenorrhea (absence of menstrual bleeding) for the preceding six months AND the presence of follicle-stimulating hormone (FSH) in the post-menopausal range.
- Secondary Outcome Measures
Name Time Method Rate of Ovarian Dysfunction at 1 Year 1 year Ovarian dysfunction is defined as amenorrhea for the preceding three months and the presence of FSH, estradiol and/or inhibin B levels in the postmenopausal range.
Rate of Ovarian Dysfunction at 2 Years 2 years Ovarian dysfunction is defined as amenorrhea for the preceding three months and the presence of FSH, estradiol and/or inhibin B levels in the postmenopausal range.
Trial Locations
- Locations (34)
Royal North Shore Hospital
🇦🇺St. Leonards, New South Wales, Australia
Royal Hobart Hospital
🇦🇺Hobart, Tasmania, Australia
Monash Medical Center - Clayton Campus
🇦🇺Clayton, Victoria, Australia
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
CHU Liege - Domaine Universitaire du Sart Tilman
🇧🇪Liege, Belgium
Ospedale degli Infermi - ASL 12
🇮🇹Biella, Italy
Oncology Institute of Southern Switzerland - Lugano
🇨ðŸ‡Lugano, Switzerland
Flinders Medical Centre
🇦🇺Bedford Park, South Australia, Australia
Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
Peter MacCallum Cancer Centre
🇦🇺East Melbourne, Victoria, Australia
Maroondah Hospital
🇦🇺East Ringwood, Victoria, Australia
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Oncology Institute of Southern Switzerland
🇨ðŸ‡Bellinzona, Switzerland
Centre Hospitalier Regional de la Citadelle
🇧🇪Liege, Belgium
European Institute of Oncology
🇮🇹Milano, Italy
National Institute of Oncology
ðŸ‡ðŸ‡ºBudapest, Hungary
Ospedali Riuniti di Bergamo
🇮🇹Bergamo, Italy
Ospedale Alessandro Manzoni
🇮🇹Lecco, Italy
Inselspital Bern
🇨ðŸ‡Bern, Switzerland
Regionalspital
🇨ðŸ‡Thun, Switzerland
Auckland City Hospital
🇳🇿Auckland, New Zealand
Centre Hospitalier Universitaire Vaudois
🇨ðŸ‡Lausanne, Switzerland
Oncology Institute of Southern Switzerland - Locarno
🇨ðŸ‡Locarno, Switzerland
Oncology Institute of Southern Switzerland - Mendrisio
🇨ðŸ‡Mendrisio, Switzerland
Centre Hospitalier Hutois
🇧🇪Huy, Belgium
Newcastle Mater Misericordiae Hospital
🇦🇺Waratah, New South Wales, Australia
Ballarat Oncology and Haematology Services
🇦🇺Ballarat, Victoria, Australia
AZ Damiaan
🇧🇪Oostende, Belgium
Centre Hospitalier Peltzer-La Tourelle
🇧🇪Verviers, Belgium
Ospedale Civile Ramazzini
🇮🇹Carpi, Italy
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
Mater Hospital - North Sydney
🇦🇺North Sydney, New South Wales, Australia
Royal Adelaide Hospital Cancer Centre
🇦🇺Adelaide, South Australia, Australia
St. Vincent's Hospital - Melbourne
🇦🇺Fitzroy, Victoria, Australia