Combination Chemotherapy in Treating Patients With Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT00003088
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs at different times or combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy consisting of either doxorubicin, cyclophosphamide, or paclitaxel given at different times with that of combination chemotherapy consisting of doxorubicin plus cyclophosphamide followed by paclitaxel in treating women with stage II or stage IIIA breast cancer.
- Detailed Description
OBJECTIVES: I. Compare the sequential chemotherapy with doxorubicin, paclitaxel and cyclophosphamide to combined doxorubicin and cyclophosphamide followed by paclitaxel for disease free and overall survival in women with node positive stage II or IIIA breast cancer. II. Determine whether increasing the dose density of adjuvant chemotherapy will improve disease free and overall survival. III. Compare the toxicity in patients treated with these regimens.
OUTLINE: This is a randomized study. Patients are randomized into one of four arms (sequential chemotherapy every 2 weeks vs every 3 weeks vs concurrent chemotherapy followed by paclitaxel every 2 weeks vs every 3 weeks). All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy plus axillary node dissection. Adjuvant chemotherapy is started within 84 days following the last surgical procedure. Arm I: Patients receive sequential chemotherapy every 3 weeks. Doxorubicin IV is administered once every 3 weeks for 4 doses. Paclitaxel IV is then administered over 3 hours once every 3 weeks for 4 doses. Cyclophosphamide IV is administered once every 3 weeks for 4 doses following paclitaxel. Arm II: Patients receive sequential chemotherapy every 2 weeks. Doxorubicin IV is administered once every 2 weeks for 4 doses. Paclitaxel IV is then administered over 3 hours once every 2 weeks for 4 doses. Cyclophosphamide IV is administered once every 2 weeks for 4 doses following paclitaxel. Filgrastim (G-CSF) is administered by subcutaneous injection on days 3-10 after each dose of doxorubicin, paclitaxel, and cyclophosphamide. Arm III: Patients receive combination chemotherapy every 3 weeks. Combination doxorubicin IV and cyclophosphamide IV is administered once every 3 weeks for 4 doses. Paclitaxel IV is administered over 3 hours once every 3 weeks for 4 doses following combination chemotherapy. Arm IV: Patients receive combination chemotherapy every 2 weeks. Combination doxorubicin IV and cyclophosphamide IV is administered once every 2 weeks for 4 doses. Paclitaxel IV is administered over 3 hours once every 2 weeks for 4 doses following combination chemotherapy. G-CSF is administered by subcutaneous injection on days 3-10 after each dose of doxorubicin/cyclophophamide and after each dose of paclitaxel. After completion of all chemotherapy, patients receive tamoxifen orally for 5 years. Patients undergo radiotherapy 4-6 weeks after the completion of chemotherapy. Patients are followed every 6 months for 5 years, then annually until death.
PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study within 22 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 2005
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sequential chemotherapy 21 days cyclophosphamide Patients received doxorubicin 60 mg/m\^2 every 3 weeks for four cycles followed by paclitaxel 175 mg/m\^2 every 3 weeks for four cycles followed by cyclophosphamide 600 mg/m\^2 every 3 weeks for four cycles. Sequential chemotherapy 21 days doxorubicin hydrochloride Patients received doxorubicin 60 mg/m\^2 every 3 weeks for four cycles followed by paclitaxel 175 mg/m\^2 every 3 weeks for four cycles followed by cyclophosphamide 600 mg/m\^2 every 3 weeks for four cycles. Sequential chemotherapy 21 days paclitaxel Patients received doxorubicin 60 mg/m\^2 every 3 weeks for four cycles followed by paclitaxel 175 mg/m\^2 every 3 weeks for four cycles followed by cyclophosphamide 600 mg/m\^2 every 3 weeks for four cycles. Concurrent chemotherapy 14 days cyclophosphamide Patients received doxorubicin 60 mg/m\^2 plus cyclophosphamide 600 mg/m\^2 every 2 weeks for four cycles followed by paclitaxel 175 mg/m\^2 every 2 weeks for four cycles with filgrastim days 3 to 10 of each cycle at 5 µg/kg rounded to either 300 or 480 µg total dose. Concurrent chemotherapy 14 days doxorubicin hydrochloride Patients received doxorubicin 60 mg/m\^2 plus cyclophosphamide 600 mg/m\^2 every 2 weeks for four cycles followed by paclitaxel 175 mg/m\^2 every 2 weeks for four cycles with filgrastim days 3 to 10 of each cycle at 5 µg/kg rounded to either 300 or 480 µg total dose. Sequential chemotherapy 14 days paclitaxel Patients received doxorubicin 60 mg/m2 every 2 weeks for four cycles followed by paclitaxel 175 mg/m2 every 2 weeks for four cycles followed by cyclophosphamide 600 mg/m2 every 2 weeks for four cycles, with filgrastim days 3 to 10 of each cycle (a total of seven doses) at 5 µg/kg, which could be rounded to either 300 or 480 µg total dose. Sequential chemotherapy 14 days cyclophosphamide Patients received doxorubicin 60 mg/m2 every 2 weeks for four cycles followed by paclitaxel 175 mg/m2 every 2 weeks for four cycles followed by cyclophosphamide 600 mg/m2 every 2 weeks for four cycles, with filgrastim days 3 to 10 of each cycle (a total of seven doses) at 5 µg/kg, which could be rounded to either 300 or 480 µg total dose. Concurrent chemotherapy 14 days paclitaxel Patients received doxorubicin 60 mg/m\^2 plus cyclophosphamide 600 mg/m\^2 every 2 weeks for four cycles followed by paclitaxel 175 mg/m\^2 every 2 weeks for four cycles with filgrastim days 3 to 10 of each cycle at 5 µg/kg rounded to either 300 or 480 µg total dose. Sequential chemotherapy 14 days doxorubicin hydrochloride Patients received doxorubicin 60 mg/m2 every 2 weeks for four cycles followed by paclitaxel 175 mg/m2 every 2 weeks for four cycles followed by cyclophosphamide 600 mg/m2 every 2 weeks for four cycles, with filgrastim days 3 to 10 of each cycle (a total of seven doses) at 5 µg/kg, which could be rounded to either 300 or 480 µg total dose. Concurrent chemotherapy 21 days cyclophosphamide Patients received doxorubicin 60 mg/m\^2 plus cyclophosphamide 600 mg/m\^2 every 3 weeks for four cycles followed by paclitaxel 175 mg/m\^2 every 3 weeks for four cycles. Concurrent chemotherapy 21 days paclitaxel Patients received doxorubicin 60 mg/m\^2 plus cyclophosphamide 600 mg/m\^2 every 3 weeks for four cycles followed by paclitaxel 175 mg/m\^2 every 3 weeks for four cycles. Concurrent chemotherapy 21 days doxorubicin hydrochloride Patients received doxorubicin 60 mg/m\^2 plus cyclophosphamide 600 mg/m\^2 every 3 weeks for four cycles followed by paclitaxel 175 mg/m\^2 every 3 weeks for four cycles.
- Primary Outcome Measures
Name Time Method Disease free survival 4 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
CCOP - Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
Siouxland Hematology-Oncology
🇺🇸Sioux City, Iowa, United States
CentraCare Clinic
🇺🇸Saint Cloud, Minnesota, United States
Quain & Ramstad Clinic, P.C.
🇺🇸Bismarck, North Dakota, United States
Altru Health Systems
🇺🇸Grand Forks, North Dakota, United States
Saskatchewan Cancer Agency
🇨🇦Regina, Saskatchewan, Canada
CCOP - Sioux Community Cancer Consortium
🇺🇸Sioux Falls, South Dakota, United States
CCOP - Ochsner
🇺🇸New Orleans, Louisiana, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
CCOP - Ann Arbor Regional
🇺🇸Ann Arbor, Michigan, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
CCOP - Cedar Rapids Oncology Project
🇺🇸Cedar Rapids, Iowa, United States
CCOP - Toledo Community Hospital Oncology Program
🇺🇸Toledo, Ohio, United States
CCOP - Merit Care Hospital
🇺🇸Fargo, North Dakota, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States