Neoadjuvant Combination Therapy in Early-Stage Triple-Negative Breast Cancer
Posted: Tuesday, January 23, 2018
The efficacy and safety of treating patients with early-stage triple-negative breast cancer using atezolizumab in combination with nab-paclitaxel as neoadjuvant therapy will be tested in the phase III, double-blind, randomized, multicenter, placebo-controlled IMpassion031 study, led by Elizabeth A. Mittendorf, MD, PhD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues. Details regarding the study were presented at the 2017 San Antonio Breast Cancer Symposium (SABCS; Abstract OT2-07-03).
Half of the approximately 204 patients will receive atezolizumab with nab-paclitaxel for 12 weeks followed by 4 cycles of atezolizumab and doxorubicin plus cyclophosphamide before surgery. The remainder of patients will receive a placebo instead of atezolizumab. Patients in the atezolizumab arm will continue to receive atezolizumab after surgery.
The primary endpoint of the study is pathologic complete response. Researchers will also measure patient-recorded outcomes, pathologic complete response according to programmed cell death ligand 1 (PD-L1) immune cell status, event-free survival, and overall survival. Atezolizumab is an anti–PD-L1 monoclonal antibody that blocks the binding of PD-L1 to programmed cell death protein 1 (PD-1) and B7.1 receptors.
