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This dataset is available to Authorized Users of the Project Data Sphere Cancer Research Platform through an initiative with the National Cancer Institute (NCI) of the U.S. National Institutes of Health (NIH). To gain access to this dataset, you must complete the following steps:

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Breast

A Phase III Study of Regional Radiation Therapy in Early Breast Cancer

Unique Data Set IDnci-data-18
DownloadableNo
SponsorNCIC Clinical Trials GroupData ProviderNCITotal Study Enrolled Patients1832RandomizationYesPubMed (PMID)26200977.00ClinicalTrial.gov IDNCT03015701ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00005957
Study PhaseClinical Study Phase IIIBlinding MethodOtherType(s) of dataN/AIntervention TypeRadiationData Set TypeOther

Clinical Trial Title

A Phase III Study of Regional Radiation Therapy in Early Breast Cancer

Trial Summary and Conditions

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation to the tumor site and surrounding area may kill more tumor cells. It is not yet known if radiation therapy to the breast alone following surgery is more effective than radiation therapy to the breast plus surrounding tissue in treating invasive breast cancer. PURPOSE: This randomized phase III trial is studying radiation therapy to the breast alone to see how well it works compared to radiation therapy to the breast plus surrounding tissue in treating women who have undergone surgery for early-stage invasive breast cancer.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: Compare the overall survival, disease-free survival, isolated local regional disease-free survival, and distant disease-free survival in women with previously resected, early stage, invasive breast cancer treated with breast radiotherapy with or without regional radiotherapy. Compare the toxic effects of these regimens in these patients. Compare the quality of life of patients (in certain participating centers) treated with these regimens. Compare the cosmetic outcomes in patients (in certain participating centers) treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to number of positive nodes (0 vs 1-3 vs more than 3), number of axillary nodes removed (<10, > or equal to 10); type of chemotherapy (anthracycline containing vs other vs none), hormonal therapy (yes vs no), number of axillary lymph nodes excised*, and participating center. Patients are randomized to one of two treatment arms.

Outcome Measures

Primary: Overall Survival [ Time Frame: 10 years ] Secondary: Disease-free Survival [ Time Frame: 10 years ]

ClinicalTrial.gov

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

Available Downloads:

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00005957-D3-Data-Dictionary.pdf

DATA: NCT00005957-D3-Dataset.csv

OTHER: README.pdf