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Type(s) of Cancer
Breast
Study Phase
Phase 3
Study Completion Date
February 2004
NCT00003857Uploaded 04-09-2017
Access via NCI by Request
PDS UID: nci-data-353
Phase III Trial of Tamoxifen Alone vs. Tamoxifen Plus Radiation Therapy for Good Risk Duct Carcinoma In-Situ (DCIS) of the Female Breast
Provider Information
Provider Data DescriptionThis dataset will allow users to reproduce the treatment comparison between Arm 1 and Arm 2 in trial NCT00003857.
SponsorRadiation Therapy Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. It is not yet known if radiation therapy is more effective than observation, with or without tamoxifen, in treating ductal carcinoma in situ. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with that of observation, with or without tamoxifen, in treating women who have ductal carcinoma in situ.
ConditionsBreast Cancer
Intervention TypeDrug: tamoxifen citrate
Procedure: adjuvant therapy
Radiation: radiation therapy
Drug(s)Drug: tamoxifen citrate
Total Enrolled636
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionObservation +/- tamoxifen for 5 years - Active Comparator
Radiation therapy +/- tamoxifen for 5 years - Experimental
Secondary IDCDR0000067020
PubMed (PMID)25605856
34406870
Collaborator(s)National Cancer Institute (NCI)
Cancer and Leukemia Group B
NCIC Clinical Trials Group
NRG Oncology
Region(s)United States
Canada
Age Range26 Years to 120 Years (Adult, Older Adult)
Files: NCT00003857-D1
Data DictionaryNCT00003857-D1-Data-Dictionary.pdf
DATANCT00003857-D1-Dataset.csv
OTHERREADME.pdf
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