Combination Chemotherapy in Treating Women With Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00003519
- 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. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating women with breast cancer who have undergone surgery to remove the tumor.
- Detailed Description
OBJECTIVES: I. Determine whether doxorubicin/docetaxel (DD) will improve disease-free survival and overall survival when compared to doxorubicin/cyclophosphamide (DC) in women with lymph node positive (1-3 positive nodes) or high risk lymph node negative breast cancer. II. Compare the toxicity of DD to DC in this patient population.
OUTLINE: This is a randomized study. Patients are stratified by node status (positive vs negative), menopause status (pre- vs post), estrogen receptor (ER) status/progesterone receptor (PR) status (ER/PR unknown vs ER+/PR+ vs ER+/PR- vs ER-/PR+ vs ER-/PR-). Patients in arm I receive doxorubicin IV plus docetaxel IV over 1 hour every 3 weeks for 4 treatment courses. Patients in arm II receive doxorubicin IV plus cyclophosphamide IV every 3 weeks for 4 treatment courses. All patients who are estrogen receptor or progesterone receptor positive receive oral tamoxifen daily for 5 years following chemotherapy. Some patients may also receive radiotherapy following chemotherapy. Patients are followed every 3 months if patient is less than 2 years from study entry; every 6 months if patient is 2-5 years from study entry; and every 12 months if patient is greater than 5 years from study entry.
PROJECTED ACCRUAL: Approximately 2778 patients will be accrued for this study within 2.5 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 2778
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 (134)
Veterans Affairs Medical Center - Birmingham
🇺🇸Birmingham, Alabama, United States
MBCCOP - University of South Alabama
🇺🇸Mobile, Alabama, United States
CCOP - Greater Phoenix
🇺🇸Phoenix, Arizona, United States
Veterans Affairs Medical Center - Phoenix (Hayden)
🇺🇸Phoenix, Arizona, United States
Veterans Affairs Medical Center - Tucson
🇺🇸Tucson, Arizona, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Veterans Affairs Medical Center - Little Rock (McClellan)
🇺🇸Little Rock, Arkansas, United States
Beckman Research Institute, City of Hope
🇺🇸Duarte, California, United States
University of California San Diego Cancer Center
🇺🇸La Jolla, California, United States
Scroll for more (124 remaining)Veterans Affairs Medical Center - Birmingham🇺🇸Birmingham, Alabama, United States