Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Neoadjuvant Chemotherapy

Inclusion Criteria

• •Patients with histologically confirmed invasive adenocarcinoma of the breast.
• •Triple negative breast cancer: hormone receptor negative (ER \< 10% and PgR \< 10%) and HER2 negative (IHC 0/1+ or ISH non-amplified), as defined by the local pathology laboratory.
• •Clinical stage at presentation: T1-4, N0-3, M0, with indications for neoadjuvant chemotherapy.
• •Patient must have received platinum and taxanes neoadjuvant chemotherapy for at least 4 cycles and no tumor progression occurred.
• •Patients should have undergone adequate tumor excision in the breast and lymph nodes after neoadjuvant chemotherapy.
• •Residual invasive disease must be ≥1cm in the breast, and/or have positive axillary lymph nodes observed on pathologic exam after neoadjuvant chemotherapy.
• •ECOG Performance Status: 0-1.
• •Patients without severe heart, lung, liver and kidney disease.
• •Adequate hematologic and end-organ function.
• •No more than 6 weeks may elapse between definitive breast surgery and randomization.