NCT00431106

Vinorelbine and Gemcitabine Versus Capecitabine in Pretreated Metastatic Breast Cancer

A Multicenter Randomized Phase III Study of Combination Treatment With Vinorelbine and Gemcitabine Versus Capecitabine Monotherapy in Metastatic Breast Cancer Patients Following Treatment Failure With the Combination of a Taxane and an Anthracycline

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Hellenic Oncology Research Group · Academic / Other
• Sex: Female
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The combination of vinorelbine and gemcitabine seems to be an important part of the chemotherapy regimens used in metastatic breast cancer patients following treatment failure with the combination of a taxane and an anthracycline. Capecitabine rescue monotherapy in metastatic breast cancer patients following treatment failure with the combination of a taxane and an anthracycline, also seems to be an important part of the chemotherapy regimens used in metastatic breast cancer patients. Whether the combination of vinorelbine and gemcitabine or capecitabine administration is preferable is not yet known, especially in patients with metastatic disease.

Detailed description

This trial will compare the efficacy of combination treatment with Vinorelbine and Gemcitabine versus Capecitabine monotherapy in metastatic breast cancer patients following treatment failure with the combination of a taxane and an anthracycline.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine	Gemcitabine at the dose of 1000 mg/m2 intravenously (IV) every 2 weeks for 12 consecutive cycles
DRUG	Capecitabine	Capecitabine at the dose of 1250 mg/m2 twice daily orally (os), from day 1 to day 14, every 3 weeks for 6 consecutive cycles
DRUG	Vinorelbine	Vinorelbine at the dose of 25 mg/m2 IV on day 1 every 2 weeks for 12 consecutive cycles

Timeline

• Start date: 2002-04-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2007-02-05
• Last updated: 2009-09-28

Locations

10 sites across 1 country: Greece