A Dose-Escalation Study Evaluating the Combination of Trastuzumab Emtansine (T-DM1) With Neratinib in Women With Metastatic HER2-Positive Breast Cancer

Summary

This study is being done for the following reasons: * The study has two parts. The purpose of the first part (Phase I) of the study is to find out the highest dose of neratinib that can be given safely with T-DM1. * The purpose of the second part of the study (Phase II) is to find out whether the dose of neratinib with T-DM1 determined in Phase I will keep breast cancer from getting worse for a period of time. * In order to learn more about study therapy levels in blood and discover genetic and protein changes associated with cancer, the study includes special research tests using samples from blood and from breast tumor. Blood samples will be collected before study treatment, once during treatment, and after study treatment stops. * In the optional part of this study, three biopsies will be performed to obtain fresh tumor samples from an area where your cancer has spread.

Timeline

Start

2014-08

Primary completion

2020-12

Completion

2021-08

Publications

• Jacobs SA, Wang Y, Abraham J, Feng H, Montero AJ, Lipchik C, Finnigan M, Jankowitz RC, Salkeni MA, Maley SK, Puhalla SL, Piette F, Quinn K, Chang K, Nagy RJ, Allegra CJ, Vehec K, Wolmark N, Lucas PC, Srinivasan A, Pogue-Geile KL. NSABP FB-10: a phase Ib/II trial evaluating ado-trastuzumab emtansine (T-DM1) with neratinib in women with metastatic HER2-positive breast cancer. Breast Cancer Res. 2024 Apr 22;26(1):69. doi: 10.1186/s13058-024-01823-8.
• Abraham J, Montero AJ, Jankowitz RC, Salkeni MA, Beumer JH, Kiesel BF, Piette F, Adamson LM, Nagy RJ, Lanman RB, Sperinde J, Huang W, Allegra CJ, Srinivasan A, Wang Y, Pogue-Geile KL, Lucas PC, Jacobs SA. Safety and Efficacy of T-DM1 Plus Neratinib in Patients With Metastatic HER2-Positive Breast Cancer: NSABP Foundation Trial FB-10. J Clin Oncol. 2019 Oct 10;37(29):2601-2609. doi: 10.1200/JCO.19.00858. Epub 2019 Aug 23.

Drugs

Indications