NCT00193076

Combination Gemcitabine, Carboplatin With or Without Trastuzumab in Patients With Metastatic Breast Cancer

A Phase II Trial of Combination Gemcitabine, Carboplatin With or Without Trastuzumab in Patients With Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Pre-clinical data suggests that combination therapy with gemcitabine and carboplatin is synergistic, and both drugs may be synergistic with trastuzumab. Additionally, recent clinical data suggest that the combination of gemcitabine with platinum is an active regimen in metastatic breast cancer. This study will test the combination of gemcitabine with carboplatin in patients with metastatic breast cancer. Patients with Her2/neu overexpression will be stratified to receive trastuzumab in addition to gemcitabine and carboplatin.

Detailed description

Upon determination of eligibility, all patients will receive the following treatment: Gemcitabine + Carboplatin

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine	Gemcitabine
DRUG	Carboplatin	Carboplatin
DRUG	Trastuzumab	Trastuzumab

Timeline

• Start date: 2003-11-01
• Primary completion: 2006-05-01
• Completion: 2008-10-01
• First posted: 2005-09-19
• Last updated: 2011-05-03

Locations

1 site across 1 country: United States