Paclitaxel or Docetaxel in Treating Women With Advanced Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00002662
- Lead Sponsor
- Aventis Pharmaceuticals
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether paclitaxel is more effective than docetaxel for breast cancer.
PURPOSE: Randomized phase III trial to study the effectiveness of paclitaxel or docetaxel in treating women with stage IIIB or metastatic breast cancer.
- Detailed Description
OBJECTIVES:
* Compare the response rate in women with metastatic or locally advanced, inoperable adenocarcinoma of the breast treated with docetaxel vs paclitaxel.
* Compare the toxicity of these regimens in these patients.
* Compare the time to disease progression, duration of response, quality of life, and survival of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive paclitaxel IV over 3 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and after courses 4 and 6.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 400 patients (200 per arm) will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (32)
Montclair Regional Cancer Center
🇺🇸Birmingham, Alabama, United States
Highlands Oncology Group, P.A. - Fayetteville
🇺🇸Fayetteville, Arkansas, United States
Northeast Arkansas Clinic
🇺🇸Jonesboro, Arkansas, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
California Cancer Care, Inc.
🇺🇸Greenbrae, California, United States
Green Cancer Center at Scripps Clinic
🇺🇸La Jolla, California, United States
Sidney Kimmel Cancer Center
🇺🇸San Diego, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
🇺🇸Denver, Colorado, United States
Norwich Cancer Center
🇺🇸Norwich, Connecticut, United States
George Washington University Medical Center
🇺🇸Washington, District of Columbia, United States
Scroll for more (22 remaining)Montclair Regional Cancer Center🇺🇸Birmingham, Alabama, United States