Radiotherapy in Early Breast Cancer

Inclusion Criteria1

• Histologically proven invasive carcinoma of the breast and no evidence of metastatic disease.- Investigations, including ER receptor status, and chest x-ray, and any additional investigations to rule out metastatic disease performed within 9 months prior to randomization.- A history and physical exam including weight, performance status and measurement of upper andlower arm circumferences performed within 12 weeks prior to randomization.- A bilateral mammogram performed within 12 months prior to randomization.- Patients must have been treated with Breast conservation therapy (BCT) (eg. lumpectomy, partial mastectomy, or segmental mastectomy) and axillary node dissection or sentinel node biopsy and considered a candidate for breast radiation. - Patients must be at high risk of regional recurrence, due to 1) pathologically positive axillary nodes, or2) pathologically negative axillary nodes anda) primary tumor > 5 cm orb) primary tumor > 2 cm and <10 axillary nodes removed and one of the following: ER negative, Skarf-Bloom-Richardson (SBR) grade 3 or lymphovascular invasion.Note: Patients with sentinel node dissection are eligible if they are node negative but still meet thehigh risk criteria. However, if they are node positive, a level I and II axillary dissection must be performed.- Patients must be treated with adjuvant systemic treatment, either currently accepted chemotherapy and/or hormonal therapy. (Patients may also have planned chemotherapy concurrently with theirradiation therapy.)- Performance status must be Eastern Cooperative Onocology Group (ECOG) 0, 1, or 2.- Patients should be planned and started on radiation as soon as possible after randomization.- Protocol treatment (radiotherapy) must begin within 8 weeks of the completion of adjuvant chemotherapy, unless radiotherapy is given concurrently with chemotherapy (ie CMF), or within 16weeks of the last surgical procedure for patients receiving hormonal therapy only.Patient’s life expectancy is >5 years- Women of childbearing potential must be using adequate contraception while receiving radiotherapy.