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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 CancerUnique Dataset IDnci-data-370ClinicalTrial.gov IDNCT00068601
Clinical Trial Title
Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer
Trial Summary and Conditions
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.
See data dictionary for more details.
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.
Primary: Rate of Premature Ovarian Failure at 2 Years [ Time Frame: 2 years ] Secondary: Rate of Ovarian Dysfunction at 2 Years [ Time Frame: 2 years ] Rate of Ovarian Dysfunction at 1 Year [ Time Frame: 1 year ]
Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):
This dataset will allow users to reproduce the results reported in the New England Journal of Medicine (Moore et al., NEJM, 2015, PMID referenced above) for trial NCT00068601.
Available Downloads: NCT00068601-D1
To gain access to the data and analytic tools click here.
Data Dictionary: NCT00068601-D1-Data-Dictionary.pdf