Major inclusion criteria | Major exclusion criteria |
---|---|
● Female 18–70 years old | ● History of systemic anticancer therapy for invasive breast cancer, chemotherapy, or radiation therapy |
● HER2/neu positive or negative, histologically proven, lymph node-positive or high-risk lymph node-negative breast cancer | ● Cardiac disease or poorly controlled hypertension |
● Definitive breast surgery within 28 to 60 days consisting of mastectomy; breast conserving surgery with axillary lymph node dissection or sentinel lymph node biopsy for operable breast cancer (T1-3, N0-1, M0) | ● Other serious medical issues |
● Normal cardiac, hematologic, and liver function | ● Minor surgical procedure within 7 days or major surgical procedure within 28 days prior to day 1 of study treatment or any anticipated surgical procedure during the chemotherapy portion of the study |