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Type(s) of Cancer
Breast
Study Phase
Phase 3
Study Completion Date
January 2014
NCT00068601Uploaded 12-23-2017
Access via NCI by Request
PDS UID: nci-data-370
Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer
Provider Information
Provider Data DescriptionThis 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.
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: 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.
ConditionsBreast Cancer
Infertility
Menopausal Symptoms
Intervention TypeDrug: cyclophosphamide
Drug: goserelin acetate
Drug(s)Drug: cyclophosphamide
Drug: goserelin acetate
Total Enrolled257
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionStandard Chemotherapy - Active Comparator
Chemotherapy Plus Goserelin - Experimental
Secondary IDS0230
PubMed (PMID)25738668
Collaborator(s)National Cancer Institute (NCI)
Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
International Breast Cancer Study Group
Region(s)Australia
Belgium
Hungary
Italy
New Zealand
Switzerland
Age RangeMinimum Age: 18 Years
Maximum Age: 49 Years
Files: NCT00068601-D1
Data DictionaryNCT00068601-D1-Data-Dictionary.pdf
DATANCT00068601-D1-Dataset.csv
OTHERREADME.pdf
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