Chemotherapy in Treating Women With Breast Cancer That Can Be Surgically Removed
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT00002707
- Lead Sponsor
- NSABP Foundation Inc
- 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 chemotherapy given before surgery is more effective with or without docetaxel given before or after surgery for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy using doxorubicin and cyclophosphamide with or without docetaxel in treating women who have stage II or stage III breast cancer.
- Detailed Description
OBJECTIVES: I. Compare overall and disease-free survival in patients with operable adenocarcinoma of the breast treated with 4 courses of preoperative doxorubicin and cyclophosphamide (AC) alone vs 4 courses of preoperative or postoperative docetaxel (TXT) following 4 courses of preoperative AC. II. Evaluate whether the addition of preoperative TXT to preoperative AC results in improved rates of clinical and pathologic locoregional tumor response. III. Assess whether the addition of preoperative TXT to preoperative AC results in improved rates of breast conservation. IV. Assess whether postoperative TXT improves disease-free and overall survival in patients who receive preoperative AC, especially in certain subgroups of patients (e.g., those with pathologically positive nodes).
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (under 50 vs 50 and over), clinical tumor size (less than 2.1 cm vs 2.1-4.0 cm vs greater than 4.0 cm), clinical nodal status (negative vs positive), and participating center. Patients are randomized to one of three treatment arms. Arm I: Patients receive doxorubicin IV followed by cyclophosphamide IV over 30 minutes to 2 hours on day 1 every 21 days for 4 courses. Patients receive oral tamoxifen daily for 5 years, starting on day 1. After completion of chemotherapy, patients are offered surgery (e.g., lumpectomy with axillary node dissection, or modified radical mastectomy). Post-operative radiotherapy is given post-lumpectomy. Arm II: Patients receive doxorubicin IV followed by cyclophosphamide IV over 30 minutes to 2 hours followed by docetaxel IV over 1 hour on day 1 once every 21 days for 4 courses. Patients receive oral tamoxifen daily for 5 years, starting on day 1. After the completion of chemotherapy, surgery is offered (as in arm I). Radiotherapy follows surgery in post-lumpectomy patients. Arm III: Patients receive doxorubicin IV followed by cyclophosphamide IV over 30 minutes to 2 hours on day 1 every 21 days for 4 courses. Patients receive oral tamoxifen daily for 5 years, starting on day 1. After completion of chemotherapy, surgery is offered (as in arm I). After surgical recovery, docetaxel IV is given over 1 hour once every 21 days for 4 courses. Radiotherapy follows docetaxel in post-lumpectomy patients. Chemotherapy is repeated every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 5 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 2,400 patients will be accrued for this study within 5 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 2411
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2 Docetaxel doxorubicin and cyclophosphamide plus Taxotere prior to surgery plus tamoxifen Group 2 Doxorubicin doxorubicin and cyclophosphamide plus Taxotere prior to surgery plus tamoxifen Group 3 Doxorubicin doxorubicin and cyclophosphamide followed by surgery followed by taxotere plus tamoxifen Group 1 Cyclophosphamide doxorubicin and cyclophosphamide plus tamoxifen Group 2 Cyclophosphamide doxorubicin and cyclophosphamide plus Taxotere prior to surgery plus tamoxifen Group 2 Tamoxifen doxorubicin and cyclophosphamide plus Taxotere prior to surgery plus tamoxifen Group 3 Cyclophosphamide doxorubicin and cyclophosphamide followed by surgery followed by taxotere plus tamoxifen Group 3 Docetaxel doxorubicin and cyclophosphamide followed by surgery followed by taxotere plus tamoxifen Group 3 Tamoxifen doxorubicin and cyclophosphamide followed by surgery followed by taxotere plus tamoxifen Group 1 Tamoxifen doxorubicin and cyclophosphamide plus tamoxifen Group 1 Doxorubicin doxorubicin and cyclophosphamide plus tamoxifen
- Primary Outcome Measures
Name Time Method Determine if 4 cycle of pre-op or post-op Taxotere given after 4 cycles of pre-op AC will more effectively prolong survival (S) than does 4 cycles of pre-op AC alone. Time from randomization to death from any cause.
- Secondary Outcome Measures
Name Time Method Prolonging disease-free survival (DFS). Time from randomization to first related event of inoperable disease; residual disease following surgery; local, regional or distant recurrence; second primary cancer; death from any cause other than cancer. Clinical loco-regional tumor response to preoperative chemotherapy. 3-4 weeks after the last cycle of pre-op chemotherapy. Pathologic loco-regional tumor response to pre-op chemotherapy. At time of surgery. Breast conservation assessment. Assessed following surgery. Evaluate if post-op Taxotere is of benefit in patients who received pre-op AC and, if so, whether it is of benefit in certain subgroups of patients. DFS and S will be assessed in patient subgroups.
Trial Locations
- Locations (145)
Huntsville Hospital System
🇺🇸Huntsville, Alabama, United States
CCOP - Greater Phoenix
🇺🇸Phoenix, Arizona, United States
Sutter Health Western Division Cancer Research Group
🇺🇸Greenbrae, California, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Saint Mary Medical Center - Long Beach
🇺🇸Long Beach, California, United States
Beckman Research Institute, City of Hope
🇺🇸Los Angeles, California, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
Comprehensive Cancer Centers of the Desert
🇺🇸Palm Springs, California, United States
Kaiser Permanente-Southern California Permanente Medical Group
🇺🇸San Diego, California, United States
Scroll for more (135 remaining)Huntsville Hospital System🇺🇸Huntsville, Alabama, United States