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RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, and
paclitaxel, work in 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 whether
giving cyclophosphamide together with doxorubicin is more effective than giving paclitaxel
alone in treating breast cancer.
PURPOSE: This randomized phase III trial is studying cyclophosphamide and doxorubicin to see
how well they work compared to paclitaxel in treating women with invasive breast cancer.
Active, not recruiting
Ages:18 and older
DISEASE CHARACTERISTICS: - Histologically confirmed invasive carcinoma of the breast with 0-3 positive axillary lymph nodes - Meets 1 of the following criteria for node-negative disease: - Negative sentinel lymph node biopsy - At least 6 negative axillary lymph nodes removed and determined to be negative by axillary dissection - Meets 1 of the following criteria for node-positive disease (1-3 positive axillary lymph nodes): - At least 1 positive lymph node by sentinel lymph node biopsy AND at least 6 axillary lymph nodes removed by axillary dissection; of all the nodes removed from both the sentinel lymph node biopsy and the axillary dissection, 1-3 must be positive - At least 6 lymph nodes removed by axillary dissection; 1-3 nodes from the axillary dissection must be positive - "High-risk" disease that warrants chemotherapy (ultimately determined by the treating physician) - Modified radical mastectomy or lumpectomy within the past 84 days required - Negative tumor margins for invasive cancer and ductal carcinoma in situ (DCIS) - Lobular carcinoma in situ (LCIS) at the margin allowed - Multicentric disease allowed provided margins and axillary nodes are negative after resection - Bilateral synchronous disease allowed - Invasive cancer on one side and DCIS or LCIS on the contralateral side is allowed provided all other eligibility criteria are met - No locally advanced, inflammatory, or metastatic breast cancer - No dermal lymphatics involvement, even if there are no clinical signs of inflammatory cancer - HER2/neu positive, negative, or unknown - Hormone receptor status: - Any estrogen and/or progesterone receptor status PATIENT CHARACTERISTICS: Age: - 18 and over Sex: - Female Menopausal status: - Premenopausal or postmenopausal Performance status: - CTC 0-1 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal Renal: - Creatinine no greater than 2.0 mg/dL Cardiovascular: - No active congestive heart failure - No myocardial infarction within the past 6 months Other: - Not pregnant or nursing - Fertile patients must use effective nonhormonal contraception during and for at least 2 months after study participation - No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior trastuzumab (Herceptin^®) for this malignancy Chemotherapy: - See Disease Characteristics - No prior chemotherapy for this malignancy - No other concurrent chemotherapy Endocrine therapy: - No prior hormonal therapy for this malignancy except tamoxifen given for up to 4 weeks - Prior tamoxifen or other selective estrogen receptor modulators (SERMs) for prevention or other indications (e.g., osteoporosis) allowed - No concurrent exogenous hormonal therapy (including oral contraceptives, postmenopausal hormone replacement therapy, or raloxifene) except: - Steroids for adrenal failure - Hormonal agents for nondisease-related conditions (e.g., insulin for diabetes or synthroid for hypothyroidism) - Intermittent dexamethasone as an antiemetic and premedication for paclitaxel - No concurrent tamoxifen or other SERMs Surgery: - See Disease Characteristics Other: - No concurrent dexrazoxane - No concurrent raloxifene - Concurrent bisphosphonates for osteoporosis allowed - Concurrent trastuzumab (Herceptin^®) allowed for patients with HER2-positive disease - Concurrent enrollment on adjuvant bisphosphonate studies allowed - Concurrent enrollment on adjuvant hormonal studies allowed provided hormonal therapy does not commence until completion of study chemotherapy
Sponsor: Cancer and Leukemia Group B
Phase: Phase 3
Trial ID: NCT00041119
Not Accepting Healthy Volunteers