Breast Cancer With Intraoperative Radiotherapy Followed by Hypofractionated External Beam Radiotherapy

Cosmetic Outcomes Following Conservative Surgery (With or Without Oncoplastic Surgery) for Breast Cancer With Intraoperative Radiotherapy (INTRABEAM) Followed by Hypofractionated External Beam Radiotherapy: a Phase II Trial

To evaluate cosmetic outcomes after conservative surgery for breast cancer with INTRABEAM followed by hypofractionated external beam radiotherapy

To evaluate cosmetic outcomes following conservative surgery (with or without oncoplastic surgery) for breast cancer with intraoperative radiotherapy (INTRABEAM) followed by hypofractionated external beam radiotherapy

Inclusion Criteria:

• Histologically-confirmed diagnosis of invasive breast carcinoma and eligibility for conservative surgery (with or without oncoplastic surgery) and radiotherapy.
• Not pregnant at diagnosis.
• Signed informed consent form.
• Age ≥45 years old.
• Patients candidates to Intrabeam.
• Patients with ≥60 years with the presence of one or more of the following adverse criteria after surgery:
• Tumor size > 2.5 cm.
• Extensive intraductal carcinoma (≥25%)
• Lymphovascular invasion.
• Involved focal margins (<2mm) without ampliation surgery.

Exclusion Criteria:

• Presence of distant metastasis.
• Primary chemotherapy.
• Lymph node involvement.
• Negative hormonal receptors.
• Diagnosis of any other infiltrating tumour except for adequately resected squamous or basal cell epitheliomas
• Patients with collagen vascular disease (systemic lupus erythematosus, scleroderma, dermatomyositis).
• Uncontrolled infection.
• Concurrent treatment with other experimental treatments
• Lack of signed informed consent form.