Ensayos clínicos

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