Hypofractionated Radiotherapy Post-Lumpectomy in Women With Node Negative Breast Cancer

Inclusion criteria

• The female patient has a histological diagnosis of invasive carcinoma of the breast, and no evidence of metastatic disease.
• Has had a lumpectomy (including segmental resection and partial mastectomy), that is, surgical excision of the tumour with a rim of normal tissue.
• Patient has not had an axillary dissection, OR for patients who have had an axillary dissection, all nodes are negative for metastatic disease.

Exclusion criteria

• Tumour greater than 5 cm in greatest diameter on pathological examination.
• The presence of invasive or intraductal (noninvasive) breast cancer involving the surgical margins.
• Clinical evidence prior to surgery of infiltration of the skin of the involved breast such as edema, ulceration, or fixation of the tumour to underlying muscle, or inflammatory breast cancer.
• Bilateral malignancy of the breast (synchronous or metachronous).
• More than one primary invasive tumour in the same breast.
• Previous surgery for breast cancer.
• Pathological status of axilla is unknown.
• Status for adjuvant systemic therapy not determined.
• For patients not treated with adjuvant chemotherapy: unable to commence radiation therapy within 16 weeks of last surgical procedure on the breast.
• For patients treated with adjuvant chemotherapy: unable to commence radiation therapy within 8 weeks of the last dose of chemotherapy.
• Serious nonmalignant disease (eg. cardiovascular, renal, etc.) which would preclude surgical or radiation treatment.
• Currently pregnant or lactating.
• Breast deemed too large to permit satisfactory radiation (ie. separation > 25 cm).
• Previous concomitant malignancies of any type except squamous, or basal cell carcinomas of the skin, or carcinoma \\fIin situ\\fR of the cervix which have been effectively treated.
• Geographic inaccessibility for follow-up.
• Psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol.