Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for Breast Cancer



Status:Archived
Conditions:Breast Cancer, Cancer, Women's Studies
Therapuetic Areas:Oncology, Reproductive
Healthy:No
Age Range:Any
Updated:7/1/2011

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Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative 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.


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 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.


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