NCT00006682

Vinorelbine and Docetaxel in Treating Women With Metastatic Breast Cancer

An Open-Label Phase II Study of Navelbine (Vinorelbine Tartrate) and Taxotere (Docetaxel) as First-Line Therapy for Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Medstar Health Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of vinorelbine combined with docetaxel in treating women who have metastatic breast cancer.

Detailed description

OBJECTIVES: I. Determine the response rate in women with metastatic breast cancer treated with vinorelbine and docetaxel. II. Determine the time to disease progression, time to treatment failure, response duration, and survival in this patient population treated with this regimen. OUTLINE: This is a multicenter study. Patients receive vinorelbine IV on days 1 and 8, and docetaxel IV over 1 hour on day 1 only. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed for 1 month, and then every 1.5-3 months for 1 year. PROJECTED ACCRUAL: Approximately 69 patients will be accrued for this study.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	docetaxel	Docetaxel 70mg/m2 on day 1 of every 21-day cycle
DRUG	vinorelbine ditartrate	Navelbine 20mg/m2 on Day 1 and D8 of a 21-day cycle

Timeline

• Start date: 2000-02-01
• Primary completion: 2002-01-22
• Completion: 2002-01-22
• First posted: 2004-05-04
• Last updated: 2020-08-14

Locations

2 sites across 1 country: United States