SCCA Breast Cancer Clinical Trials

DISEASE CHARACTERISTICS:

• Histologically confirmed breast cancer

  • Metastatic disease

• Basaloid phenotype, as demonstrated by all of the following:

  • Estrogen receptor-negative tumor
  • Progesterone receptor-negative tumor
  • HER2/neu non-overexpressing tumor

• Measurable disease by RECIST criteria OR nonmeasurable disease only, defined as the following:

  • Measurable disease

    • X-rays, scans, or physical examinations used for tumor measurement must have been completed within 28 days prior to registration

  • Nonmeasurable disease only

    • X-rays, scans, or other tests for assessment of nonmeasurable disease must have been performed within 42 days prior to registration
    • Rising serum CA15-3 or CA 27.29 OR CEA documented by two consecutive measurements taken at least 14 days apart with the most recent measurement being within 42 days prior to registration
    • Second CA 15-3 or CA 27.29 OR CEA value must have at least a 20% increase over the first AND CA 15-3 or CA 27.29 greater than or equal to 40 units/mL OR CEA greater than or equal to 4 ng/mL
• Planning to receive first-line therapy for metastatic disease
• No recurrent disease within 12 months after completion of adjuvant chemotherapy containing a weekly taxane
• No CNS metastases

PATIENT CHARACTERISTICS:

• Menopausal status not specified

• No proteinuria at screening, as demonstrated by either of the following:

  • Urine protein:creatinine ratio < 1.0
  • Proteinuria < 2+ by urine dipstick OR proteinuria ≤ 1 g by 24-hour urine collection
• No pre-existing nephritic syndrome
• No inadequately controlled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg and/or diastolic BP > 100 mm Hg despite antihypertensive medications
• No history of hypertensive crisis or hypertensive encephalopathy
• No NYHA class II-IV congestive heart failure
• No myocardial infarction or unstable angina within the past 6 months
• No stroke or transient ischemic attack within the past 6 months
• No significant vascular disease (e.g., aortic aneurysm, aortic dissection)
• No symptomatic peripheral vascular disease
• No evidence of bleeding diathesis or coagulopathy
• No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
• No serious, non-healing wound, ulcer, or bone fracture
• No significant traumatic injury within the past 28 days
• No known hypersensitivity to any component of bevacizumab
• No concurrent serious medical or psychiatric illness, including serious active infection
• Negative pregnancy test
• Fertile patients must use effective contraception during and for ≥ 2 weeks after completion of study therapy

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• More than 28 days since prior major surgical procedure or open biopsy
• More than 7 days since prior core biopsy or other minor surgical procedure, excluding placement of a vascular access device
• No concurrent major surgical procedure
• No other concurrent chemotherapy, immunotherapy, antitumor hormonal therapy, or radiotherapy
• No other concurrent investigational drugs
• Concurrent bisphosphonates allowed