Clinical Research Directory

Inclusion Criteria: * Male or female ≥18 years. * Histologically confirmed stage I-III epithelial breast cancer. * Adequate surgery of breast and axilla: 1. patients must have undergone either a total mastectomy or breast conserving surgery 2. surgical margins of the resected specimen must be histologically free of invasive tumor. * Cohort 1: if chemotherapy and/or radiotherapy are indicated the patients must be randomized between 1 month and 2 months from the end of chemotherapy and/or radiotherapy; if only hormonal adjuvant therapy is indicated the patients must be randomized within 3 months from the completion of surgery * Cohort 2: patients must be randomized in the trial after 5 years of follow-up without relapse (but within year 6) * Signed informed consent obtained prior to any study-specific procedures. Exclusion Criteria: * Histologically confirmed stage 0 epithelial breast cancer (carcinoma in situ). * Special histologies with a high or low risk of relapse (i.e. sarcoma and tubular carcinoma) * T1a and T1b tumors with all the following characteristics: G1-2 and N0 and RE \> 10%, RPg \> 10% and HER2 negative and Ki67≤14% * Evidence of distant metastases * Patients participating to other clinical trials requiring follow-up not equal to standard * Previous history of cancer within 5 years from randomization (except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, stage I uterine cancer, or other non-breast malignancies with an outcome similar to those mentioned above)