Sunitinib in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer Who Have Tumor Cells in the Bone Marrow
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: sunitinib malate; flow cytometry; immunohistochemistry staining method; laboratory biomarker analysis
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage IA breast cancer; stage IB breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer

Summary:

      RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth and by blocking blood flow to the tumor.

      PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with
      stage I, stage II, or stage III breast cancer who have tumor cells in the bone marrow.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed high-risk breast cancer

               -  Stage I-III disease

          -  Has undergone definitive surgery with or without radiotherapy

               -  Completely resected disease

          -  Bone marrow aspirate positive for occult tumor cells, defined as ≥ 10 occult tumor
             cells/mL by IHC and flow cytometry

               -  If the patient received either no adjuvant therapy or hormonal therapy alone, the
                  aspiration may have been performed at diagnosis as part of the large
                  micrometastasis study at UCSF, or following diagnosis if the patient underwent
                  initial surgery elsewhere (or underwent surgery following neoadjuvant therapy for
                  breast cancer)

               -  If the patient received adjuvant chemotherapy, the aspiration must have been
                  performed ≥ 3 weeks after completion of chemotherapy

          -  Hormone receptor status not specified

        PATIENT CHARACTERISTICS:

          -  Menopausal status not specified

          -  ECOG performance status 0-1

          -  WBC count normal (3.4-10 x 10^9/L)

          -  Hemoglobin > 9.0 g/dL

          -  Platelet count normal (140-450 x 10^9/L)

          -  ANC normal (1.8-6.8 x 10^9/L)

          -  Serum creatinine ≤ 1.5 times upper limit of normal (ULN)

          -  Total bilirubin ≤ 1.5 times ULN

          -  Alkaline phosphatase ≤ 1.5 times ULN

          -  AST and ALT ≤ 2.5 times ULN

          -  TSH and T4 levels normal

          -  LVEF > 50%

          -  Systolic BP < 140 mm Hg and diastolic BP < 90 mm Hg

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No history of HIV infection

          -  No concurrent severe illness that would likely preclude study compliance

          -  No other malignancy within the past 5 years except basal cell carcinoma of the skin

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No prior sunitinib malate

          -  Prior adjuvant chemotherapy, including trastuzumab (Herceptin®), allowed provided it
             was completed within the past 6 months

          -  Prior surgery following neoadjuvant chemotherapy or hormonal therapy allowed

          -  No concurrent potent CYP3A4 inducers

          -  No concurrent trastuzumab

          -  Concurrent hormonal therapy or radiotherapy allowed