About ExteNET

 

The ExteNET study was a randomised, double-blind, placebo-controlled Phase 3 investigation examining the efficacy and safety of 12 months of NERLYNX (neratinib) after trastuzumab-based adjuvant therapy in patients with early-stage HER2-positive breast cancer. Eligible women (aged ≥18 years, or ≥20 years in Japan) had stage 1–3 HER2-positive breast cancer and had completed neoadjuvant and adjuvant trastuzumab therapy up to 2 years before randomisation. Inclusion criteria were amended in February 2010 to include patients with stage 2–3 HER2-positive breast cancer who had completed trastuzumab therapy up to 1 year previously. Patients were randomly assigned (1:1) to receive oral neratinib 240 mg per day or matching placebo. The study met its primary endpoint.