Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for Breast Cancer
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.
Drug: goserelin acetate
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|Official Title:||Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer|
- Rate of premature ovarian failure at 2 years [ Designated as safety issue: No ]
- Rate of ovarian dysfunction at 1 and 2 years [ Designated as safety issue: No ]
- Ovarian reserve at 1 and 2 years [ Designated as safety issue: No ]
|Study Start Date:||October 2003|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Experimental: Arm I
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.
Part of planned chemotherapy regimenDrug: goserelin acetate
Active Comparator: Arm II
Patients receive cyclophosphamide-containing chemotherapy alone.
Part of planned chemotherapy regimen
- 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.
- 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 I: 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.
- Arm II: Patients receive cyclophosphamide-containing chemotherapy alone. Patients are followed at 1, 2, and 5 years.
PROJECTED ACCRUAL: A total of 416 patients (208 per treatment arm) will be accrued for this study within 3 years.
Show 34 Study Locations
|Investigator:||Halle C.F. Moore, MD||The Cleveland Clinic|
|Investigator:||Kathy S. Albain, MD||Loyola University|
|Investigator:||Silvana Martino, DO||John Wayne Cancer Institute at Saint John's Health Center|
|Study Chair:||Ann H. Partridge, MD, MPH||Dana-Farber Cancer Institute|
|Study Chair:||Lori J. Goldstein, MD||Fox Chase Cancer Center|
|Study Chair:||Kelly-Anne Phillips||Peter MacCallum Cancer Centre, Australia|