Safety and Efficacy of T-DM1 Plus Neratinib in Patients With Metastatic HER2-Positive Breast Cancer: NSABP Foundation Trial FB-10
Relentless targeting of ERBB2 (HER2) has utility in cancers expressing this target. A small dose escalation study of ado-trastuzumab emtansine (T-DM1) plus neratinib showed ORR 63% in patients who had failed trastuzumab and pertuzumab.
This study reports the recommended phase II dose of T-DM1 3.6 mg/kg and neratinib 160 mg/d for this combination. Possible resistance mechanisms to HER2 antibodies may be loss of the HER2 receptor and high expression of p95HER2. These data provide the basis for an ongoing phase II study to better define the activity of this regimen.