Status: Closed
Activation Date: 1999DEC14
Closing Date: 2007FEB02
Phase: III
Description: A Phase III Study of Regional Radiation Therapy in Early Breast Cancer
Eligibility: Pre or post menopausal women with node positive and high risk node-negative breast cancer treated by breast conserving therapy and currently accepted adjuvant chemotherapy and/or hormonal therapy.
Objective: To determine if regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes) in addition to breast radiation prolongs survival in women with early breast cancer compared with breast radiation alone. To compare disease free survival, isolated local regional disease-free survival, and distant disease free survival. To evaluate toxicity. To evaluate quality of life. To determine the cosmetic outcome of these two treatment approaches.
Participation: Not limited.
Lay Description: The purpose of the study is to find out whether it is better to receive breast radiation or the breast radiation plus radiation to the surrounding lymph glands or nodes (regional radiation). This will determine if regional radiation will prevent distant spread of the cancer and cause women to live longer by keeping the cancer from coming back.
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Inventory
Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| BREAST | MA20 | 1832 | 1138 | 938 | 1292 |
(Core size is 0.6 mm)
Hide
Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| BREAST | MA20 | 1832 | 16 | 1064 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| BREAST | MA20 | 1832 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |