NSABP B-50-I (Katherine): Trastuzumab Emtansine versus Trastuzumab as Adjuvant Therapy for Patients with HER2+ Primary Breast Cancer Who have Residual Tumor Present Pathologically in the Breast or Axillary lymph Nodes Following Preoperative Therapy
Purpose: This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the breast or axillary lymph nodes following preoperative therapy. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6 mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14 cycles. Radiotherapy and/or hormone therapy will be given in addition if indicated.
Cancer () - Breast
Tanya Wahl, M.D.
Swedish Cancer Institute
- HER2-positive breast cancer
- Clinical stage T1-4/N0-3/M0 at presentation (patients with T1a/bN0 tumors will not be eligible)
- Completion of preoperative systemic treatment consisting of at least 6 cycles with a total duration of at least 16 weeks, including at least 9 weeks of trastuzumab and at least 9 weeks of taxane-based therapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- No stage IV (metastatic) breast cancer
- No history of any prior (ipsi- or contralateral breast cancer except lobular carcinoma in situ
- No evidence of clinically evident gross residual or recurrent disease following preoperative therapy and surgery
- No progressive disease during preoperative therapy
- No patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons
- No hstory of exposure to the f...