drugset / Trial / NCT02544997

A Phase II, Single-Arm Trial of Poziotinib as Salvage Treatment in Patients With Metastatic Breast Cancer Who Has HER2 or EGFR Mutation or Activated AR or EGFR Pathway

NCT02544997

Phase 2 Completed 5 enrolled Samsung Medical Center
NaSingle-groupOpen-labelTreatment

Summary

Metastatic breast cancer (MBC) is an incurable disease and is needed to improve effective therapeutic strategies including targeted agents. Poziotinib is a panHER tyrosin kinase inhibitor (TKI) that showed stable activity with feasible toxicity for MBC patients as a salvage treatment strategy after failure of anthracycline and taxane in phase I trial. Poziotinib has rational benefit compared with other salvage agents, especially for patients with HER2 overexpression breast cancers. Additionally, a recent report showed that possible rational background for patients with HER2 mutation-positive breast cancers. Based on this rationale, the investigators are to conduct phase II single-arm study of poziotinib for patients with MBC who showed refractoriness to conventional treatments as salvage treatment.

Timeline

Start
2015-09
Primary completion
2020-02
Completion
2020-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Poziotinib Small molecule 12 mg Oral

Indications