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A Phase III Study of Regional Radiation Therapy in Early Breast CancerUnique Dataset IDnci-data-3
This dataset will allow users to reproduce the treatment comparison between nodal-irradiation group and the control group in trial NCT00005957.
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.
See data dictionary for more details.
OBJECTIVES: Compare the efficacy of whole breast radiotherapy vs observation with or without optional tamoxifen in decreasing or delaying the appearance of local failure (both invasive and in situ) and preventing the need for mastectomy in women with good-risk ductal carcinoma in situ (DCIS) of the breast. Compare distant disease-free survival of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (under 50 vs 50 and over), final path margins (negative vs 3-9 mm vs at least 10 mm), mammographic size of primary (no greater than 1 cm vs greater than 1 cm to 2.5 cm), nuclei grade (low vs intermediate), and tamoxifen use (yes vs no). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo observation and may receive optional oral tamoxifen once daily (at the discretion of the physician) for 5 years. Arm II: Beginning within 12 weeks after final surgery, patients receive radiotherapy to the whole breast once daily, 5 days a week, for 3.5-5.5 weeks. Patients may receive optional tamoxifen as in arm I. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 1,790 patients will be accrued for this study within 6 years.
Primary: Overall Survival [ Time Frame: 10 years ] Secondary: Disease-free Survival [ Time Frame: 10 years ] Disease-free survival (including locoregional and distant disease)
Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):
To gain access to the data and analytic tools click here.
Data Dictionary: NCT00005957-D2-Data-Dictionary.pdf