NCT01238029

Dose Finding Study for Combination of Capecitabine, Lapatinib and Vinorelbine in Metastatic Breast Cancer

Combinational Therapy of Capecitabine, Lapatinib and Vinorelbine for the Treatment of Patients With her2/Neu Positive, Relapsed or Metastatic Breast Carcinoma Following Treatment Failure With Trastuzumab

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Sponsor GmbH · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to investigate safety and efficiency of the triple combination of capecitabine, lapatinib and vinorelbine in patients with metastatic breast cancer.

Detailed description

The combination of lapatinib with capecitabine ist a standard therapy für Her2 positive metastatic breast cancer. This study combines this therapy with the additional antimitotic mode of function by vinorelbine.

Conditions

• Metastatic Breast Cancer
• HER2 Positive
• First or Second Line Therapy
• Failure or Contraindication of Trastuzumab Therapy

Interventions

Type	Name	Description
DRUG	Lapatinib and Capecitabine and Vinorelbine	Dose finding Study Lapatinib: 1000-1250 oral, once daily, days 1-21 Capecitabine: 1000 mg/sqm oral, bid, days 1-14 Vinorelbine 10-22,5 mg/sqm, i.v. Day 1 + 8

Timeline

• Start date: 2010-10-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2010-11-10
• Last updated: 2014-11-21

Locations

11 sites across 1 country: Germany