Randomized Trial of Post-Mastectomy Radiotherapy in Stage II Breast Cancer in Women With One to Three Positive Axillary Nodes, Phase III

Hist. conf. adenocarcinoma of the female breast; primary tumor 2 5 cm and 1-3 positive axillary lymph nodes (pathologic T1-2, pathologic N1); lymph nodes positive by cytokeratin staining only are not eligible; pathologic N2 or N3, pathologic T3, pathologic or clinical T4, or M1 disease; no apocrine, adenocystic, or squamous carcinomas or sarcomas of the breast; no bilateral breast cancer; patients must have undergone modified radical mastectomy sparing the pectorialis minor muscle with level I and II +/- III axillary dissection; minimum 10 nodes removed and examined; negative surgical margins for both invasive carcinoma and non-invasive ductal carcinoma; no clincally matted nodes, gross extracapsular disease or residual disease in the axilla; microscopic extracapsular extension (ECE) is allowed; patients with mastectomy after local failure following lumpectomy are not eligible; no active local-regional disease; Patients may be registered either prior to, during or immediately after completion systemic chemotherapy or prior to or during administration of hormonal therapy. RT must begin within 8 months after mastectomy and should be planned to begin within 6 weeks of completing systemic chemotherapy ; registration to another adjuvant chemotherapy or hormonal therapy trial is allowed if allowed by that trial; hormonal therapy (if prescribed) may be delivered concurrent with radiation or may have already begun; no prior trastuzumab (herceptin) therapy; no other prior chemotherapy except for treatment of current breast cancer; no prior chest wall or nodal radiation therapy; at least 21 years of age; radiation consult to be completed prior to registration.