In patients who have received adjuvant treatment with anthracyclines or cyclophosphamide, a minimum of 12 months from treatment with anthracyclines or cyclophosphamide until relapse of disease is required.Female patients of childbearing potential should have a negative urine or serum pregnancy test within 7 days before receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
The baseline assessment included a medical history, a full clinical examination, a complete blood count , a comprehensive blood chemistry panel and a cardiac assessment by electrocardiogram and echocardiography. CBC and blood chemistry were repeated on day 1 of each treatment cycle, and a full clinical examination, electrocardiogram and echocardiography were repeated every 4th cycle.
Tumor evaluation by CT of the chest, abdomen and pelvis and a bone scan was performed within 21 days of randomization and repeated every 8 weeks from the first day of treatment for the first 12 months and every 12 weeks thereafter. Response evaluation was done using iRECIST, a version of the RECIST modified to capture the response patterns of immunotherapies