Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Positive Breast Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed invasive breast cancer, meeting all of the following staging criteria:

  • Primary tumor T1-3 by clinical and pathological evaluation
  • Ipsilateral lymph nodes cN0, cN1, or cN2a by clinical evaluation

  • Ipsilateral lymph nodes pN1 (pN1mi, pN1a, pN1b, or pN1c), pN2a, pN3a, or pN3b* by pathologic evaluation

    • Must have completed 1 of the following procedures for evaluation of pathological nodal status:

      • Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes

      • Sentinel lymphadenectomy alone allowed provided 1 of the following criteria is met:

        • Pathologic nodal staging based on sentinel lymphadenectomy is pN1mi or pN1b
        • No additional non-sentinel lymph nodes are removed
      • Axillary lymphadenectomy without sentinel lymph node isolation procedure NOTE: *Only if due to microscopic involvement of internal mammary node detected by sentinel lymph node dissection AND has > 3 positive axillary lymph nodes

• Must have undergone prior lumpectomy or total mastectomy

  • Lumpectomy patients:

    • Surgical margins must be histologically free of invasive tumor AND ductal carcinoma in situ (DCIS) (lobular carcinoma in situ [LCIS] allowed)

      • Additional operative procedures may be performed to obtain clear margins* even if axillary evaluation has been completed
    • No diffuse tumors* by mammography
    • No other clinically dominant mass or mammographically suspicious abnormality within the ipsilateral breast unless proven to be histologically benign OR if malignant, surgically removed with clear margins
    • Planned whole breast irradiation required NOTE: *Patients with persistent positive margins or diffuse tumors must undergo total mastectomy to be eligible for this study
• No more than 84 days since last surgery for breast cancer staging or treatment
• No clinical or radiologic evidence of metastatic disease
• No contralateral breast cancer (invasive breast cancer or DCIS)
• No mass or mammographic abnormality in the opposite breast suspicious for malignancy unless there is biopsy evidence that the mass is not malignant
• No suspicious nodes in the contralateral axilla or suspicious supraclavicular nodes unless there is biopsy evidence of no tumor involvement

• No prior breast cancer, including DCIS

  • LCIS allowed

• Hormone receptor status:

  • Estrogen receptor (ER) status known
  • Progesterone receptor status known only if ER-negative

PATIENT CHARACTERISTICS:

Age

• Not specified

Sex

• Female

Menopausal status

• Not specified

Performance status

• Zubrod 0-1

Life expectancy

• At least 10 years

Hematopoietic

• Absolute granulocyte count ≥ 1,200/mm^3
• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin ≤ upper limit of normal (ULN)* (1.5 times ULN if due to Gilbert's disease or similar syndrome)
• Alkaline phosphatase ≤ 2.5 times ULN*
• AST ≤ 1.5 times ULN*
• No hepatic disease that would preclude study participation NOTE: *Bilirubin, AST, OR alkaline phosphatase > ULN allowed provided no metastatic liver disease is present on imaging

Renal

• Postoperative creatinine ≤ ULN
• No renal disease that would preclude study participation

Cardiovascular

• LVEF ≥ lower limit of normal by echocardiogram or MUGA

• No cardiac disease that would preclude the use of anthracyclines, including any of the following:

  • History of myocardial infarction documented by elevated cardiac enzymes or regional wall abnormalities
  • Angina pectoris requiring anti-anginal medication
  • Documented history of congestive heart failure
  • Serious cardiac arrhythmia requiring medication
  • Severe conduction abnormality
  • Valvular disease with documented cardiac function compromise
  • Uncontrolled hypertension, defined as blood pressure > 160/100 mm Hg with antihypertensive therapy
• No other cardiovascular disease that would preclude study participation

Other

• Not pregnant or nursing
• Fertile patients must use effective non-hormonal contraception

• No other malignancy within the past 5 years except treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, melanoma in situ, or carcinoma in situ of the colon

  • Considered to be low-risk for recurrence
• No condition that would preclude corticosteroid administration
• No sensory or motor neuropathy ≥ grade 2
• No other nonmalignant systemic disease that would preclude study participation
• No psychiatric or addictive disorder or other condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for current breast cancer
• No prior anthracycline or taxane therapy for any malignancy

Endocrine therapy

• See Disease Characteristics
• Prior hormonal therapy for breast cancer allowed provided the duration of therapy was ≤ 28 days and it was administered before study entry

• No concurrent sex hormonal therapy (e.g., birth control pills, ovarian hormone replacement therapy, or Femring®)

  • Concurrent Vagifem® or Estring® for the management of vaginal or urinary symptoms allowed
• No concurrent raloxifene, tamoxifen, or other selective estrogen-receptor modulators (SERMs) for osteoporosis or breast cancer prevention

Radiotherapy

• See Disease Characteristics
• No prior radiotherapy for current breast cancer
• No concurrent partial breast irradiation (lumpectomy patients)
• Concurrent irradiation of regional lymph nodes allowed provided plans are declared prior to study entry

Surgery

• See Disease Characteristics

Other

• Concurrent calcium supplements, cholecalciferol (vitamin D), calcitonin (e.g., Miacalcin®), or bisphosphonates (e.g., Actonel® or Fosamax®) for the management of osteoporosis allowed
• No other concurrent investigational agents for the treatment of breast cancer