Study of Neratinib +Trastuzumab or Neratinib + Cetuximab in Patients With KRAS/NRAS/BRAF/PIK3CA Wild-Type Metastatic Colorectal Cancer by HER2 Status

Summary

This is a phase II trial to examine the efficacy of neratinib plus trastuzumab or neratinib plus cetuximab in patients with "quadruple wild-type" (all RAS/NRAS/BRAF/PIK3CA wild-type), metastatic colorectal cancer based on HER2 status (amplified, non-amplified \[wild-type\] or mutated). Patients must have confirmed quadruple wild-type (WT) genotype, via NSABP MPR-1 or from colonic biopsy or a metastatic biopsy taken prior to treatment, and known HER2 status.

Timeline

Start

2018-05-18

Primary completion

2021-09-30

Completion

2022-09-30

Publications

• Freeman TJ, George TJ, Jacobs SA, Yothers G, Kolevska T, Feng H, Lipchik C, Maley S, Song N, Srinivasan A, Finnigan M, Wade JL 3rd, Buchschacher GL Jr, Al Baghdadi T, Shipstone A, Lin D, Puhalla SL, Allegra CJ, Wolmark N, Pogue-Geile KL. NSABP FC-11: A phase II study of neratinib plus trastuzumab or neratinib plus cetuximab in patients with "quadruple wild-type" (KRAS/NRAS/BRAF/PIK3CA) metastatic colorectal cancer based on HER2 status: amplified, non-amplified (wild-type), or mutated. Cancer Chemother Pharmacol. 2025 Aug 9;95(1):80. doi: 10.1007/s00280-025-04802-8.

Drugs

Indications