ExteNET

NCT00878709 📎

Regimen

Experimental
Neratinib 240 mg PO daily x 1 year after completion of adjuvant trastuzumab.
Control
Placebo x 1 year.

Population

HER2-positive early breast cancer (mostly node-positive, HR-positive subset drives benefit), within 2 years of completing adjuvant trastuzumab-based therapy.

Key finding

ExteNET established extended adjuvant neratinib for 1 year after completion of trastuzumab in HER2+/HR+ high-risk early breast cancer. FDA-approved 2017; NCCN option for HR+/HER2+ high-risk patients. Diarrhea requires prophylaxis (loperamide).

Source: PMID 26874901

Timeline

  • Publication: 2016 Mar

Guideline citations

  • NCCN BREAST