Neratinib

In the ExteNET trial (NCT00878709), the safety and efficacy of 12 months of adjuvant neratinib was investigated in patients with early-stage HER2-positive breast cancer (n = 2,840) who had completed neoadjuvant trastuzumab up to 2 years before randomization. Patients received 240 mg of oral neratinib daily for 1 year or a placebo. The primary end point was IDFS.[142][Level of evidence A1]

In the ExteNET trial (NCT00878709), the safety and efficacy of 12 months of adjuvant neratinib was investigated in patients with early-stage HER2-positive breast cancer (n = 2,840) who had completed neoadjuvant trastuzumab up to 2 years before randomization. Patients received 240 mg of oral neratinib daily for 1 year or a placebo. The primary end point was IDFS.[142][Level of evidence A1]

After a median follow-up of 5.2 years (interquartile range, 2.1–5.3), patients in the neratinib group had significantly fewer IDFS events than those in the placebo group (neratinib group, 116 events vs. placebo group, 163 events; stratified HR, 0.73; 95% CI, 0.57–0.92; P = .0083). The 5-year IDFS rate was 90.2% (95% CI, 88.3%–91.8%) in the neratinib group and 87.7% (85.7%–89.4%) in the placebo group.[143]

In the ExteNET trial (NCT00878709), the safety and efficacy of 12 months of adjuvant neratinib was investigated in patients with early-stage HER2-positive breast cancer (n = 2,840) who had completed neoadjuvant trastuzumab up to 2 years before randomization. Patients received 240 mg of oral neratinib daily for 1 year or a placebo. The primary end point was IDFS.[142][Level of evidence A1]

OS data are not mature.

In the ExteNET trial (NCT00878709), the safety and efficacy of 12 months of adjuvant neratinib was investigated in patients with early-stage HER2-positive breast cancer (n = 2,840) who had completed neoadjuvant trastuzumab up to 2 years before randomization. Patients received 240 mg of oral neratinib daily for 1 year or a placebo. The primary end point was IDFS.[142][Level of evidence A1]

The most common grade 1 to 2 adverse events included diarrhea (neratinib, 55% vs. placebo, 34%), nausea (41% vs. 21%), fatigue (25% vs. 20%), vomiting (23% vs. 8%), and abdominal pain (22% vs. 10%). The FDA label recommends prophylactic loperamide during the first 56 days of therapy, and as needed thereafter to help manage diarrhea.

In the ExteNET trial (NCT00878709), the safety and efficacy of 12 months of adjuvant neratinib was investigated in patients with early-stage HER2-positive breast cancer (n = 2,840) who had completed neoadjuvant trastuzumab up to 2 years before randomization. Patients received 240 mg of oral neratinib daily for 1 year or a placebo. The primary end point was IDFS.[142][Level of evidence A1]

The most common grade 3 to 4 adverse event was diarrhea (neratinib, 40% vs. placebo, 2%). All other grade 3 to 4 adverse events occurred in 2% or less of patients.