Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer
- 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
- 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
- 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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Rate of premature ovarian failure at 2 years
Ovarian failure at two years is defined as amenorrhea (absence of menstrual bleeding) for the preceding six months AND the presence of FSH in the post-menopausal range.
Halle C Moore, MD
The Cleveland Clinic
United States: Federal Government