drugset / Trial / NCT00398567

A Phase 1/2 Study Of HKI-272 (Neratinib) in Combination With Trastuzumab (Herceptin) In Subjects With Advanced Breast Cancer

NCT00398567

Phase 1/2 Completed 45 enrolled Puma Biotechnology, Inc.
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the safety and efficacy of HKI-272 (neratinib) in combination with trastuzumab in patients with advanced breast cancer.

Timeline

Start
2007-04-04
Primary completion
2009-07-31
Completion
2018-03-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Neratinib Small molecule 160 mg Oral
Subject Neratinib Small molecule 240 mg Oral
Background Trastuzumab Monoclonal antibody 2 mg/kg Intravenous

Indications