Chemotherapy in Treating Women With Previously Treated Metastatic Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00003236
- Lead Sponsor
- Eastern Cooperative Oncology Group
- 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 II trial to compare the effectiveness of ISIS 5132 with ISIS 3521 in treating women who have metastatic breast cancer that has not responded to previous therapy.
- Detailed Description
OBJECTIVES: I. Estimate the proportion of women with previously treated metastatic breast cancer who are progression free at 4 months after receiving ISIS 5132 or ISIS 3521. II. Determine duration of response to these treatment regimens in this patient population. III. Evaluate toxicities and tolerability of these treatment regimens in this patient population.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to number of prior therapies for metastatic breast cancer (1 vs 2). Patients are randomized to one of two treatment arms. (Arm I closed 12/22/99) Arm I: Patients receive ISIS 5132 IV continuously over 21 days. (closed 12/22/99) Arm II: Patients receive ISIS 3521 IV continuously over 21 days. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. After every 2 courses, patients are evaluated for response. Patients are followed every 3 months for the first 2 years, every 6 months the next 3 years, then annually thereafter.
PROJECTED ACCRUAL: A maximum of 68 patients (34 per arm) will be accrued in this study (Arm I closed 12/22/99).
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 (6)
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
🇺🇸Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Lakeside)
🇺🇸Chicago, Illinois, United States
Johns Hopkins Oncology Center
🇺🇸Baltimore, Maryland, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States