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. Author manuscript; available in PMC: 2017 Jan 24.
Published in final edited form as: N Engl J Med. 2016 Jul 7;375(1):11–22. doi: 10.1056/NEJMoa1513750

Figure 1.

Figure 1

Figure 1

Figure 1

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.