Neratinib/T-DM1 Doses Recommended for Phase II Trial in Breast Cancer

December 17, 2018
Jame Abraham, MD

Jame Abraham, MD, discusses the results for the phase Ib study of trastuzumab emtansine with neratinib in patients with HER2-positive breast cancer.

Jame Abraham, MD, professor of medicine at the Cleveland Clinic and co-director of the Cleveland Clinic Comprehensive Breast Cancer Program, discusses results from the phase Ib study of trastuzumab emtansine (T-DM1) with neratinib (Nerlynx) in patients with HER2-positive breast cancer.

The primary endpoint was to find a recommended phase II dose. For T-DM1, this dose was 3.6 mg/kg every 3 weeks, while the dose for neratinib was 160 mg daily, according to Abraham.

The FDA-approved dose of neratinib is 240 mg, but Abraham says the main side effect reported with this dose was diarrhea. Investigators saw response at 120 mg, 160 mg, and 200 mg, but the recommended dose of neratinib did not directly correlate with response.