NCT00430001

Vinorelbine Plus (+) Trastuzumab vs Docetaxel Plus (+) Trastuzumab as 1 Line Treatment for HER2 Positive (+) Metastatic Breast Cancer

A Randomised Phase III Study of Trastuzumab-Docetaxel vs Trastuzumab-Vinorelbine as 1. Line Therapy for Patients With Metastatic HER2 Positive Breast Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Danish Breast Cancer Cooperative Group · Academic / Other
• Sex: Female
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

In an open-label randomised phase III-trial patients with metastatic HER2-positive breast cancer naive to chemotherapy with normal organ function and WHO performance status \< 3 are randomised to receive either docetaxel 100 mg/m2 i.v. plus trastuzumab 6 mg/kg (8 mg/kg loading dose) q 3 weeks or vinorelbine 30 or 35 mg/m2 days 1+8 plus trastuzumab 6 mg/kg (8 mg/kg loading dose) q 3 weeks. Primary endpoint is time to progression. Secondary endpoints include overall survival, time to treatment failure, response rate, duration of response and toxicity. The study hypothesis is that docetaxel is more efficient than vinorelbine but also more toxic.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	docetaxel
DRUG	vinorelbine
DRUG	trastuzumab

Timeline

• Start date: 2005-05-01
• Completion: 2008-12-01
• First posted: 2007-02-01
• Last updated: 2008-05-09

Locations

1 site across 1 country: Denmark