S0230 Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00068601|
Recruitment Status : Completed
First Posted : September 11, 2003
Results First Posted : April 4, 2017
Last Update Posted : December 30, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Infertility Menopausal Symptoms||Drug: cyclophosphamide Drug: goserelin acetate||Phase 3|
- 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 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||257 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2003|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||September 2016|
Active Comparator: Standard Chemotherapy
Patients receive cyclophosphamide-containing chemotherapy alone.
Part of planned chemotherapy regimen
Experimental: Chemotherapy Plus Goserelin
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 regimen
Drug: goserelin acetate
- Rate of Premature Ovarian Failure at 2 Years [ Time Frame: 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.
- Rate of Ovarian Dysfunction at 2 Years [ Time Frame: 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.
- Rate of Ovarian Dysfunction at 1 Year [ Time Frame: 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.
- Ovarian Reserve at 1 and 2 Years [ Time Frame: 1 and 2 years ]Measurements of ovarian reserve will consist of "Day 2 - 4" levels of FSH, estradiol and inhibin B during Month 12/13 and Month 24/25 (or if amenorrheic, anytime during Month 12/13 and Month 24/25).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00068601
|Principal Investigator:||Halle C Moore, MD||The Cleveland Clinic|
|Study Chair:||Kathy S. Albain, MD||Loyola University|
|Study Chair:||Silvana Martino, DO||Saint John's Cancer Institute|
|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|