Shorter Anthracycline-Free Chemo Immunotherapy Adapted to Pathological Response in Early Triple Negative Breast Cancer (SCARLET), A Randomized Phase III Study
Objective
Primary Objective: To assess whether participants with early stage TNBC randomized to receive anthracycline-free, taxane-platinum neoadjuvant chemotherapy with pembrolizumab have non-inferior breast cancer event-free survival (BC-EFS) compared to participants randomized to taxane-platinum-anthracycline neoadjuvant chemotherapy with pembrolizumab.
Secondary Objectives: To compare pathological complete response (pCR) and residual cancer burden (RCB) rates by randomized arm. To compare pCR and RCB rates between randomized arms by tumor infiltrating lymphocytes (TIL) status. To compare BC-EFS between randomized arms in the TIL-enriched and non-TIL enriched subgroups. To compare distant relapse-free survival and overall survival by randomized arm. To compare invasive breast cancer-free survival after surgery between randomized arms in pCR and residual disease groups. To compare the safety and tolerability by randomized arm among those that initiate therapy.
