Efficacy and Safety of Ultra_HYPofractionated RadiotHerapy in Women With BrEast CaNcer Receiving Regional Nodal Radiation vs Nodal Moderate Hypofractionated Radiotherapy (HYPHEN)
Malignant Breast Neoplasm
About this trial
This is an interventional treatment trial for Malignant Breast Neoplasm focused on measuring Dose splitting, Acute and late toxicity, Locoregional drainage irradiation, Breast neoplasm, Overall survival, Disease-free survival, Locoregional control
Eligibility Criteria
Inclusion Criteria: Information to the patient and signed informed consent; Women aged ≥18 years; Breast conserving surgery; Invasive adenocarcinoma (except classic invasive lobular carcinoma); TNM (Tumor, Nodes, Metastasis) pathologic stage pT1-3 and pN1-3a M0, with indication of lymphatic drainage according to institutional protocol; Eastern Cooperative Oncology Group (ECOG) 0 -1; Minimum microscopic margin of non-cancerous tissue of 2 mm (excluding deep margin if in the deep fascia); No previous breast or mediastinal radiotherapy; No hematogenous metastases; Ability to carry out long-term follow-up; Exclusion Criteria: Previous local irradiation; Concomitant chemotherapy. Concomitance with trastuzumab or hormone blockade will be allowed; Histology of metaplastic carcinoma; History of another neoplasm: non-melanoma skin cancer, carcinoma in situ of the uterine cervix. Another neoplasm treated with curative intent and without evidence of disease in the last 5 years will be allowed. Diagnosis of autoimmune and connective tissue diseases; Diagnosis of genetic alterations in cell repair genes (Ex: Fanconi anemia, ataxia teleangiectasia); Indication of internal breast irradiation.
Sites / Locations
- IBCC OncologiaRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Standard Whole breast Radiotherapy
Ultra-hypofractionated whole breast radiotherapy
Standard Radiation: Whole Breast Irradiation, at 40 Gy, in 15 fractions and drainage
Ultra-hypofractionated radiation: Ultra-hypofractionated whole breast radiotherapy, 26 Gray (26Gy) in 5 fractions for one week