Ensayos clínicos

Eligibility Criteria

• Disease characteristics
  • Histologically confirmed operable stage IIA, IIB, or IIIA adenocarcinoma of the breast
  • 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
  • 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
    • No concurrent tamoxifen or other SERMs
    • 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
      • Prior tamoxifen of no more than 4 weeks duration for breast cancer allowed
  • Endocrine therapy not specified
  • 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