|Phase III||Treatment||Closed||18 and over||NCI, Other||CDR0000065788|
U10CA031946, CLB-9741, E-C9741, NCCTG-C9741, SWOG-C9741, C9741, NCT00003088
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.
Further Study Information
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.
DISEASE CHARACTERISTICS: Histologically diagnosed operable, stage II or IIIA adenocarcinoma of the breast One or more positive lymph nodes (T0-3, N1-2, and M0) Metaplastic carcinoma allowed Bilateral breast cancer allowed No metastatic disease Not locally advanced and no tumors fixed to the chest wall, peau d'orange skin changes, skin ulcerations, or clinical inflammatory changes Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin within upper limits of normal Renal: Not specified Cardiovascular: No uncontrolled or severe cardiovascular disease No myocardial infarction within 6 months No congestive heart failure Other: No other serious medical illness No psychoses No active uncontrolled bacterial, viral, or fungal infection HIV negative Not pregnant
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: No greater than 4 weeks of prior tamoxifen therapy for malignancy No concurrent tamoxifen therapy Radiotherapy: No prior radiation therapy for this malignancy Surgery: No greater than 84 days since prior mastectomy or axillary dissection
Trial Lead Organizations/Sponsors
Cancer and Leukemia Group BNational Cancer Institute
North Central Cancer Treatment Group
Eastern Cooperative Oncology Group
Southwest Oncology Group
|Marc Laurence Citron||Study Chair|
|James N. Ingle||Study Chair|
|Nancy E. Davidson||Study Chair|
|Silvana Martino||Study Chair|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00003088
Information obtained from ClinicalTrials.gov on November 20, 2012
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