At a glance
ClinicalIndex Comparison Record- ✓Histologically proven invasive carcinoma of the breast
- ✓Prior breast-conserving therapy (lumpectomy, partial or segmental mastectomy) with axillary node dissection or sentinel node biopsy required
- ✓Microscopically clear resection margins; focally positive margins (≤3 high power fields) acceptable with boost to lumpectomy site
- ✓Node-positive disease OR node-negative with high-risk features: tumor >5 cm, OR tumor 2-5 cm with <10 nodes excised AND (ER-negative OR grade 3 OR lymphovascular invasion)
- ✕T4, N2-3, or M1 disease prior to surgery
- ✕Residual disease in axilla after dissection
- ✕Serious nonmalignant cardiovascular, pulmonary, or renal disease that would preclude definitive surgery or radiotherapy
- ✕Prior radiotherapy to contralateral breast (if contralateral noninvasive breast cancer present)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Study of Regional Radiation Therapy in Early Breast Cancer
In Brief
A clinical study evaluating Standard Breast Irradiation and Breast Radiation plus Regional Radiation for Breast Cancer. Completed, enrolled 1,832 participants across 26 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.
Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields.