RAPID: Randomized Trial of Accelerated Partial Breast Irradiation

Exclusion Criteria

• •1\. Age \< 40 years.
• •2\. A known deleterious mutation in BRCA 1 and/or BRCA 2.
• •3\. Tumour size \> 3 cm in greatest diameter on pathological examination (including both the invasive and non-invasive component).
• •4\. Tumour histology limited to lobular carcinoma only.
• •5\. History of cancer:
• •* Patients with another active malignancy or malignancy treated \< 5 years prior to randomization are excluded.
• •* Patients with a prior diagnosis of invasive or non-invasive breast cancer in either breast are excluded regardless of disease free interval. Patients with concurrent invasive or non-invasive contralateral breast cancer are also excluded.
• •* Patients with prior or concurrent basal cell or squamous cell skin cancers are eligible for the trial.
• •6\. More than one primary tumour in different quadrants of the same breast.
• •7\. Previous irradiation to the ipsilateral breast that would preclude whole breast irradiation.
• •8\. Presence of an ipsilateral breast implant or pacemaker.
• •9\. Serious non-malignant disease (e.g. cardiovascular, pulmonary, systemic lupus erythematosus (SLE), scleroderma) which would preclude definitive radiation treatment.
• •10\. Estrogen receptor status (ER) not known.
• •11\. For patients not treated with adjuvant chemotherapy: unable to commence radiation therapy within 12 weeks of the last surgical procedure on the breast.
• •12\. For patients treated with adjuvant chemotherapy: unable to commence within 8 weeks of the last dose of chemotherapy.
• •13\. Currently pregnant or lactating.
• •14\. Psychiatric or addictive disorders which would preclude obtaining informed consent or adherence to protocol.
• •15\. Geographic inaccessibility for follow-up.
• •16\. Inability to localize surgical cavity on CT (i.e., no evidence of surgical clips or seroma).
• •17\. Inability to adequately plan the patient for the experimental technique.