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Type(s) of Cancer
Breast
Study Phase
Phase 3
Study Completion Date
2006-12
NCT00002920Uploaded 10-20-2022
Access via NCI by Request
PDS UID: nci-data-498
A Randomized Comparison Of Medroxyprogesterone Acetate (MA) And Observation For Prevention Of Endometrial Pathology In Postmenopausal Breast Cancer Patients Treated With Tamoxifen, Phase III
Provider Information
Provider Data DescriptionNCT00002920-D1 and -D2 contain the data presented in NPJ Breast Cancer (Potkul et al., NPJ, 2016; PMID 28721383). This dataset, NCT00002920-D1, contains patient-level data (one row per patient), including eligibility, evaluability, treatment, demographic, and baseline information. It also contains assessment data.
SponsorSouthwest Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: It is not yet known whether medroxyprogesterone is effective in preventing endometrial disorder in patients with breast cancer who are taking tamoxifen. PURPOSE: Randomized phase III trial to study the effectiveness of medroxyprogesterone in preventing endometrial disorder in postmenopausal women who have ductal carcinoma in situ, lobular carcinoma in situ, Paget's disease of the nipple, stage I breast cancer, or stage II breast cancer and who are taking tamoxifen.
ConditionsBreast Cancer
Endometrial Cancer
Intervention TypeDrug: medroxyprogesterone
Drug: tamoxifen citrate
Procedure: adjuvant therapy
Drug(s)Drug: tamoxifen citrate
Drug: medroxyprogesterone
Total Enrolled313
RandomizationRandomized
Blinding MethodNone
Arms InterventionTamoxifen alone - Active Comparator
Tamoxifen plus MPA - Experimental
Secondary IDCALGB-49901
PubMed (PMID)N/A
Collaborator(s)National Cancer Institute (NCI)
Cancer and Leukemia Group B
Region(s)United States
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT00002920-D1
Data DictionaryNCT00002920-D1-Data-Dictionary_0.pdf
DATANCT00002920-D1-Dataset_0.csv
OTHERREADME.pdf
Files: NCT00002920-D2
Data DictionaryNCT00002920-D2-Data-Dictionary_0.pdf
DATANCT00002920-D2-Dataset_0.csv
OTHERREADME.pdf
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