A. I-SPY 2 Adaptive Design.
B. Study Design.
Study schema for the neratinib experimental arm and control arm in I-SPY2. Following screening, HER2+ patients were randomized to receive either neratinib plus paclitaxel vs. trastuzumab plus paclitaxel. HER2− patients were randomized to receive either neratinib plus paclitaxel vs. paclitaxel alone. HER2+ and HER2− patients then received standard AC treatment to complete their neoadjuvant therapy.
C. I-SPY 2 Consort Diagram for Neratinib and Its Controls.
Did/did not received allotted intervention: Patients were categorized as receiving no experimental therapy or at least 1 dose of experimental therapy.