Douglas Yee, Claudine Isaacs, Denise M Wolf, Christina Yau, Paul Haluska, Karthik V Giridhar, Andres Forero-Torres, A Jo Chien, Anne M Wallace, Lajos Pusztai, Kathy S Albain, Erin D Ellis, Heather Beckwith, Barbara B Haley, Anthony D Elias, Judy C Boughey, Kathleen Kemmer, Rachel L Yung, Paula R Pohlmann, Debu Tripathy, Amy S Clark, Hyo S Han, Rita Nanda, Qamar J Khan, Kristen K Edmiston, Emanuel F Petricoin, Erica Stringer-Reasor, Carla I Falkson, Melanie Majure, Rita A Mukhtar, Teresa L Helsten, Stacy L Moulder, Patricia A Robinson, Julia D Wulfkuhle, Lamorna Brown-Swigart, Meredith Buxton, Julia L Clennell, Melissa Paoloni, Ashish Sanil, Scott Berry, Smita M Asare, Amy Wilson, Gillian L Hirst, Ruby Singhrao, Adam L Asare, Jeffrey B Matthews, Nola M Hylton, Angela DeMichele, Michelle Melisko, Jane Perlmutter, Hope S Rugo, W Fraser Symmans, Laura J Van't Veer, Donald A Berry, Laura J Esserman
I-SPY2 is an adaptively randomized phase 2 clinical trial evaluating novel agents in combination with standard-of-care paclitaxel followed by doxorubicin and cyclophosphamide in the neoadjuvant treatment of breast cancer. Ganitumab is a monoclonal antibody designed to bind and inhibit function of the type I insulin-like growth factor receptor (IGF-1R). Ganitumab was tested in combination with metformin and paclitaxel (PGM) followed by AC compared to standard-of-care alone. While pathologic complete response (pCR) rates were numerically higher in the PGM treatment arm for hormone receptor-negative, HER2-negative breast cancer (32% versus 21%), this small increase did not meet I-SPY's prespecified threshold for graduation...
October 5, 2021: NPJ Breast Cancer