Status: Closed
Activation Date: 2001NOV22
Closing Date: 2003JUN15
Phase: III
Description: Randomized Trial of Post-Mastectomy Radiotherapy in Stage II Breast Cancer in Women With One to Three Positive Axillary nodes
Eligibility: Women with histologically confirmed adenocarcinoma of the breast, with the primary tumour < 5 cm and 1-3 positive axillary nodes (pathologic T1-2, pathologic N1). Patients with apocrine, adenocystic, or squamous carcinomas or sarcomas of the breast or bilateral breast cancer are not eligible.
Objective: To compare overall and disease-free survival in pre- and post-menopausal women with Stage II breast cancer and 1 ? 3 positive nodes treated with or without radiation therapy following mastectomy and adjuvant chemotherapy. To assess local-regional control for this cohort of patients. To assess the potential toxicities of radiotherapy delivered using CT-directed treatment in this cohort of patients.
Participation: Limited to centres with current CPA/FWA #
Lay Description: The purpose of this study is to find out if it is better or not to receive radiotherapy treatment after chemotherapy. To do this half of the patients in this study will get radiation therapy after chemotherapy and the other half will be watched closely but receive no radiotherapy treatment. This research is being done because we do not know whether radiotherapy treatment is better for this type of breast cancer than no further treatment.
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| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| BREAST | MA25 | 3 | 2 | 1 | 2 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| BREAST | MA25 | 3 | 0 | 0 |
| 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 | MA25 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |