PET-Guided Chemotherapy and Hormone Therapy in Treating Women With Previously Untreated Invasive Breast Cancer

DISEASE CHARACTERISTICS:

• Diagnosis of invasive breast carcinoma, including any of the following subtypes:

  • Invasive ductal breast carcinoma
  • Invasive lobular breast carcinoma
  • Ductal carcinoma in situ (DCIS)
  • Inflammatory breast cancer
• No pure DCIS diagnosis or histologies with favorable prognosis (e.g., mucinous or tubular histologies)
• Measurable disease, defined as primary tumor size ≥ 1.0 cm by MRI, and/or sonographic, or clinical exam or tumors < 1.0 cm and biopsy-proven axillary lymph node metastasis present
• Previously untreated disease
• Estrogen and progesterone receptor status known
• HER2 negative or positive

PATIENT CHARACTERISTICS:

• Menopausal status not specified
• ECOG performance status (PS) 0-2 or Karnofsky PS 50-100%
• Absolute neutrophil count ≥ 1,500/mm³
• Hemoglobin ≥ 8.0 g/dL
• Platelet count ≥ 100,000/mm³
• Total bilirubin normal

• Urine protein:creatinine ratio < 1.0

  • Patients with proteinuria ≥ 2+ at baseline must undergo a 24-hour urine collection that demonstrates ≤ 1 g of protein/24 hr

• Meets 1 of the following criteria:

  • AST or ALT normal AND alkaline phosphatase (AP) ≤ 5 times upper limit of normal (ULN)
  • AST or ALT ≤ 1.5 times ULN AND AP ≤ 2.5 times ULN
  • AST or ALT ≤ 5 times ULN AND AP normal
• No peripheral neuropathy ≥ grade 2
• Negative pregnancy test
• Fertile patients must use effective contraception during and for ≥ 3 months after completion of study therapy
• Not pregnant or nursing
• No other malignancy within the past 5 years
• No known severe hypersensitivity to docetaxel or other drugs formulated with polysorbate 80

• No other serious illness or medical condition, including any of the following:

  • Cardiac thrombotic event within the past 12 months
  • Stroke or transient ischemic attack within the past 12 months
  • Poorly controlled hypertension, defined as persistent blood pressure > 150 mm Hg systolic and/or 100 mm Hg diastolic that is not responsive to medications
  • Significant vascular disease (e.g., symptomatic peripheral vascular disease)
  • Gastrointestinal condition that increases risk of perforation within 6 months of study
  • Any serious non-healing wound, ulcer, or bone fracture
  • Evidence of bleeding diathesis or coagulopathy
• Ejection fraction ≥ 50%

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy, hormonal therapy, or radiotherapy for invasive breast cancer
• No prior taxanes, anthracyclines, or cyclophosphamide
• No minor surgical procedure within the past 7 days
• No major surgery within the past 28 days or anticipation of need for major surgery during the course of this study