4. No prior treatment for primary invasive adenocarcinoma of the breast such as irradiation, chemotherapy, hormonal therapy, immunotherapy, investigational therapy or surgery other than the anthracycline and cyclophosphamide chemotherapy with or without 5-fluorouracil given as part of participation in protocol 2014-0185. Treatment for ductal carcinoma in situ is allowed, such as surgery, hormonal therapy and radiotherapy