Exclusive Intraoperative Radiation Therapy for Breast Cancer

Tolerance Evaluation of Exclusive Intraoperative Radiation Therapy at Different Doses for Breast Cancer Conservative Treatment

Aim of the study is to evaluate toxicity in breast cancer patients treated with two different doses of Intra Operative Radiotherapy

Inclusion Criteria:

• Non lobular epithelial breast carcinoma, excised with standard quadrantectomy
• Age ≥ 45 and < 85
• Tumor major diameter ≤ 2.5 cm
• Negative surgical margins (≥ 5 mm)
• Willingness to undergo follow up examinations
• Willingness to undergo imaging examinations (MRI, mammograms, ultrasonography)
• Signed informed consent

Exclusion Criteria:

• Ductal carcinoma in situ or lobular carcinoma
• Extensive intraductal component (greater than 25%) or intraductal carcinoma with microinvasion
• Serious concomitant disease or any disorder or condition (such as psychiatric or addictive disorders) that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
• Pregnancy or lactation at the time of enrolment proposal (if necessary, during the trial patients must use effective contraceptive device)
• Collagen vascular disorders