Combination of Weekly Paclitaxel With Neratinib and Trastuzumab in Women With Metastatic HER2-positive Breast Cancer

Phase 1 Completed 21 enrolled NSABP Foundation Inc Pfizer · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The FB-8 study is designed as an open label, single arm, Phase I dose-escalation study evaluating the combination of weekly paclitaxel with neratinib and trastuzumab in women with metastatic, HER2-positive breast cancer. The primary aim of this study is to determine the safety and tolerability of the three-drug combination.

Timeline

Start: 2011-05
Primary completion: 2012-08
Completion: 2014-03

Publications

Results Jankowitz RC, Abraham J, Tan AR, Limentani SA, Tierno MB, Adamson LM, Buyse M, Wolmark N, Jacobs SA. Safety and efficacy of neratinib in combination with weekly paclitaxel and trastuzumab in women with metastatic HER2-positive breast cancer: an NSABP Foundation Research Program phase I study. Cancer Chemother Pharmacol. 2013 Dec;72(6):1205-12. doi: 10.1007/s00280-013-2262-2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Neratinib	Small molecule	120 mg	Oral
Subject	Neratinib	Small molecule	160 mg	Oral
Subject	Neratinib	Small molecule	200 mg	Oral
Subject	Neratinib	Small molecule	240 mg	Oral
Background	Paclitaxel	Small molecule	80 mg/m2	Intravenous
Background	Trastuzumab	Monoclonal antibody	2 mg/kg	Intravenous

Combination of Weekly Paclitaxel With Neratinib and Trastuzumab in Women With Metastatic HER2-positive Breast Cancer

Summary

Timeline

Publications

Drugs

Indications