External Hypofractionated Radiotherapy With Simultaneous Integrated Boost in Early Breast Cancer Patients

Patients enrolled for the study, according to eligibility criteria, undergo breast conserving surgery followed by adjuvant 10-fraction whole breast irradiation with a risk adapted simultaneous-integrated boost dose at the level of the tumour bed according to clinical and pathological risk factors.

Inclusion criteria

• Histologically proven invasive or in situ unifocal adenocarcinoma of the breast
• Breast conserving surgery
• Pathological pTis G3, pT1-2 any Grade, pN0 or pN0(sn) (isolated tumor cells [i+] allowed) pN1mic, M0 stage
• Postoperative negative (no ink) final surgical margins
• Patient requires a whole breast radiotherapy plus a tumor bed boost
• Female patients aged ≥ 18 years of any menopausal status
• ECOG performance status 0-2

Exclusion criteria

• Past history of malignancy except basal cell skin cancer and CIN cervix uteri or non-breast malignancy allowed if treated with curative intent and at least 5 years' disease free
• Mastectomy
• Concomitant chemotherapy (primary or sequential chemotherapy allowed) (Chemotherapy and radiotherapy must be separated by a minimum of 2 weeks). (Patients receiving neo-adjuvant chemotherapy are not excluded)
• Known disorders associated with a higher risk for complications following radiotherapy such as collagen vascular disease, dermatomyositis, systemic lupus erythematosus or scleroderma
• Any psychological, familiar, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
• Any serious uncontrolled medical disorder, non-malignant systemic disease, or active uncontrolled infection. Example include but are not limited to uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction or uncontrolled major seizure disorder
• Pregnant or lactating patients
• Presence of ipsilateral breast implant
• Prior breast or thoracic radiotherapy for any condition