Paclitaxel With or Without Carboplatin in Treating Women With Metastatic Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00025688
- Lead Sponsor
- Theradex
- 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 if paclitaxel is more effective with or without carboplatin in treating stage IV breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel with or without carboplatin in treating women who have stage IV breast cancer.
- Detailed Description
OBJECTIVES:
* Compare the objective response rate in women treated with paclitaxel with or without carboplatin as first-line chemotherapy for metastatic breast cancer.
* Compare the overall survival, time to disease progression, and duration of response in these patients treated with these regimens.
* Compare the safety of these regimens in this patient population.
* Compare the quality of life of these patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior adjuvant chemotherapy (yes vs no) and ECOG performance status (0-1 vs 2). Patients are randomized to one of two treatment arms.
* Arm I: Patients receive paclitaxel IV over 1 hour weekly for 3 weeks.
* Arm II:Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes weekly for 3 weeks.
Treatment in both arms continues every 4 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, before each course during study, and then after completion of study.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 220 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- UNKNOWN
- 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 (25)
Scott and White Clinic
🇺🇸Temple, Texas, United States
Maryland Hematology/Oncology Associates
🇺🇸Baltimore, Maryland, United States
Oncology Consultants
🇺🇸Houston, Texas, United States
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
Highlands Oncology Group
🇺🇸Springdale, Arkansas, United States
Monterey Bay Oncology
🇺🇸Monterey, California, United States
Wilshire Oncology Medical Group, Inc.
🇺🇸Pomona, California, United States
Center for Hematology and Oncology
🇺🇸Boca Raton, Florida, United States
New Britain General Hospital
🇺🇸New Britain, Connecticut, United States
Cancer Research Network, Inc.
🇺🇸Hollywood, Florida, United States
MacNeal Cancer Center
🇺🇸Berwyn, Illinois, United States
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
Oncology Specialists, SC
🇺🇸Park Ridge, Illinois, United States
Maine Center for Cancer Medicine and Blood Disorders
🇺🇸Scarborough, Maine, United States
St. John's Mercy Medical Center
🇺🇸Saint Louis, Missouri, United States
St. Barnabas Medical Center
🇺🇸Livingston, New Jersey, United States
Finger Lakes Community Cancer Center
🇺🇸Clifton Springs, New York, United States
Scranton Hematology-Oncology
🇺🇸Scranton, Pennsylvania, United States
Clinical Hematology & Oncology Service, Inc.
🇺🇸Akron, Ohio, United States
East Tennessee Oncology/Hematology, P.C.
🇺🇸Knoxville, Tennessee, United States
West Clinic
🇺🇸Memphis, Tennessee, United States
Northern Virginia Oncology Group, P.C.
🇺🇸Fairfax, Virginia, United States
Dean Medical Center
🇺🇸Madison, Wisconsin, United States
Texas Cancer Care
🇺🇸Fort Worth, Texas, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States