Doxorubicin, Cyclophosphamide, and/or Paclitaxel in Treating Women With Nonmetastatic Breast Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed invasive breast cancer, meeting 1 of the following criteria:

  • Node negative disease AND meets 1 of the following stage criteria:

    • Primary tumor > T1c

    • Primary tumor > T1b AND poor prognostic features, defined as the following:

      • High-grade disease
      • HER2/neu-positive disease by fluorescence in situ hybridization
      • Estrogen receptor-negative disease
    • Stage II disease (T2, N0)
  • Node positive nonmetastatic disease
  • Locally advanced disease AND receiving neoadjuvant chemotherapy comprising doxorubicin and cyclophosphamide OR paclitaxel
  • Enrolled in clinical trial CALGB-40101
• No evidence of systemic metastasis

• Hormone receptor status:

  • Not specified

PATIENT CHARACTERISTICS:

Age

• 18 and over

Sex:

• Female

Menopausal status:

• Not specified

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin < 2.0 times upper limit of normal

Renal

• Creatinine < 2.0 mg/dL

Cardiovascular

• No ischemic heart disease
• No uncontrolled hypertension

Other

• Not pregnant
• No poorly controlled diabetes mellitus
• No active infection
• No peripheral neuropathy ≥ grade 2
• No other serious comorbidity

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent anticancer immunotherapy or biologic response modifiers
• No concurrent growth factors during course 1 of doxorubicin and cyclophosphamide study treatment

Chemotherapy

• See Disease Characteristics
• No prior weekly paclitaxel

Endocrine therapy

• No concurrent anticancer endocrine therapy

Radiotherapy

• Concurrent radiotherapy to the chest wall allowed for patients receiving paclitaxel only

Surgery

• At least 2 weeks since prior major surgery (e.g., wide excision, lumpectomy, or mastectomy)

Other

• More than 2 weeks since prior and no concurrent CYP450 inducers or inhibitors
• No other concurrent anticancer cytotoxic therapy
• No other concurrent investigational drugs
• No other concurrent medications known to cause myelosuppression (e.g., neutropenia) or neuropathy
• No concurrent participation in another clinical trial except for patients receiving adjuvant doxorubicin and cyclophosphamide on protocols CALGB-40101 or MA-21