Docetaxel in Treating Patients With Metastatic Breast Cancer

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Docetaxel

• Registration Number: NCT00008411
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Randomized phase III trial to determine the effectiveness of docetaxel in treating patients who have metastatic breast cancer.

Detailed Description

OBJECTIVES:

* Compare the objective tumor response rate, duration of response, time to progression, progression-free survival, and overall survival in women with metastatic breast cancer treated with docetaxel administered weekly vs every three weeks.

* Compare the safety and toxicity of these regimens in these patients.

* Evaluate the maintenance of relative dose intensity with each regimen in these patients.

* Correlate pretreatment serum HER2/neu level and response with docetaxel therapy in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior taxane use (yes vs no), number of prior chemotherapy regimens for metastatic disease (0 vs 1), and participating center. Patients are randomized to one of two treatment arms.

* Arm I: Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days.

* Arm II: Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days.

Treatment continues in both arms in the absence of disease progression or unacceptable toxicity.

Patients are followed at 3 weeks, at 3, 6, 9, and 12 months, and then annually for 4 years.

PROJECTED ACCRUAL: A total of 160 patients will be accrued for this study.

Study Timeline

• Study Start: 1999-12
• Study First Submitted: 2001-01-06
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2006-03
• Study Completion: 2007-01
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-27
• Last Update Posted: 2012-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Docetaxel Weekly	Docetaxel	Arm I: Docetaxel IV over 1 hour on day 1. Courses repeat every 21 days.
Docetaxel Every 3 Weeks	Docetaxel	Arm II: Docetaxel IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days.

Primary Outcome Measures

Name	Time	Method
Objective Tumor Response Rate	Weekly

Trial Locations

Locations (2)

MD Anderson Cancer Center at University of Texas; 🇺🇸 Houston, Texas, United States

University of Texas M.D. Anderson CCOP Research Base; 🇺🇸 Houston, Texas, United States