A Phase III Study of Doxorubicin-Cyclophosphamide Therapy Followed by Paclitaxel or Docetaxel Given Weekly or Every 3 Weeks in Patients With Axillary Node-Positive Breast Cancer

Date de début de l'étude : 16 novembre 1999

DISEASE CHARACTERISTICS: Histologically confirmed operable stage IIA, IIB, or IIIA adenocarcinoma of the breast with histologically involved lymph nodes (T1, 2, or 3; N1 or 2; M0) OR high-risk node-negative disease (T2 or 3; N0) Primary tumor at least 2.1 cm in diameter for node-negative disease Bilateral breast disease allowed if at least 1 primary tumor meets the criteria above Must have had at least 6 axillary lymph nodes removed at dissection and at least one node positive for metastasis OR Sentinel node biopsy negative for metastasis (sentinel node biopsy positive allowed if enrolled on American College of Surgery Trial Z0011 and have beenrandomized to receive no axillary dissection) Additional axillary nodes may be obtained provided they are also negative for metastasis Complete tumor removal by either a modified radical mastectomy or local excision plus axillary lymph node dissection (i.e., breast conservation therapy) or sentinel node biopsy Tumor-free margins at least 1 mm for both invasive and noninvasive carcinoma except for lobular carcinoma in situ (less than 1 mm allowed) Concurrent enrollment on American College of Surgery Trial Z0010, Z0011, or NSABP B-32 allowed Hormone receptor status: Estrogen receptor status positive, negative, or unknown PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 2 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No history of myocardial infarction No congestive heart failure No significant ischemic or valvular heart disease Other: No other prior invasive malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix No hypersensitivity to paclitaxel or docetaxel or other similarly formulated drugs (with Cremophor or polysorbate) Not pregnant or nursing Fertile patients must use effective barrier contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for breast cancer Endocrine therapy: Prior tamoxifen of no more than 4 weeks duration for breast cancer allowed Prior tamoxifen or other selective estrogen receptor modulator (SERM) for chemoprevention (e.g., Breast Cancer Prevention Trial) or for other indications (e.g., osteoporosis) allowed No concurrent tamoxifen or other SERMs Radiotherapy: No prior radiotherapy for this malignancy At least 2 weeks since prior radiotherapy to the breast for ductal carcinoma in situ Surgery: See Disease Characteristics Less than 84 days since prior surgical procedure to adequately treat primary tumor