drugset
drugset / Trial / NCT00513058

Lapatinib and Vinorelbine in Treating Women With HER2-Overexpressing Locally Advanced or Metastatic Breast Cancer

NCT00513058 ↗

Phase 1 Completed 33 enrolled UNICANCER
NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lapatinib together with vinorelbine may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib and vinorelbine in treating women with HER2-overexpressing locally advanced or metastatic breast cancer.

Timeline

Start
2007-06
Primary completion
2010-05
Completion
2012-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Lapatinib Small molecule 750 mg Oral
Subject Lapatinib Small molecule 1000 mg Oral
Subject Lapatinib Small molecule 1250 mg Oral
Subject Lapatinib Small molecule 1500 mg Oral
Subject Vinorelbine Small molecule 20 mg/m2 Intravenous
Subject Vinorelbine Small molecule 22.5 mg/m2 Intravenous
Subject Vinorelbine Small molecule 25 mg/m2 Intravenous
Subject Vinorelbine Small molecule 27.5 mg/m2 Intravenous
Subject Vinorelbine Small molecule 30 mg/m2 Intravenous

Indications

breast cancer