Primary Outcome Measures:
- Feasibility [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Nature, severity, and frequency of adverse events [ Designated as safety issue: Yes ]
- Activity (response rate) [ Designated as safety issue: No ]
- Markers of angiogenesis pre- and post-treatment [ Designated as safety issue: No ]
- Role
of both host- and tumor-specific genes pertaining to response and toxicity [ Designated as safety issue: Yes ]
- Comparison of tumor vascular parameters pre- and post-treatment [ Designated as safety issue: No ]
- Comparison of cell death and tumor microcirculation pre- and post-treatment [ Designated as safety issue: No ]
- Comparison of tumor metabolic activity pre- and post-treatment [ Designated as safety issue: No ]
OBJECTIVES:
Primary
- Determine the feasibility of neoadjuvant sunitinib malate in patients with newly diagnosed, resectable stage II-IIIA breast cancer.
Secondary
- Determine the nature, severity, and frequency of adverse events in patients treated with this drug.
- Determine the response rate in patients treated with this drug.
- Evaluate markers of angiogenesis (e.g., VEGF receptor, platelet-derived growth factor receptor, circulating plasma VEGF, sVEGFR-2, sVEGFR-3, sKIT, and tumor vascularity) both pre- and post-treatment.
- Examine the role of both host- and tumor-specific genes pertaining to response and toxicity.
- Compare tumor vascular parameters pre- and post-treatment using DCE-MRI.
- Compare cell death and tumor microcirculation pre- and post-treatment using contrast-enhanced spectroscopic and microbubble contrast-enhanced ultrasound.
- Compare tumor metabolic activity pre- and post-treatment using fludeoxyglucose F 18-PET.
OUTLINE: This is a multicenter study.
Patients receive oral sunitinib malate once daily for 14-21 days in the absence of disease progression or unacceptable toxicity.
Tissue samples are obtained by needle biopsy at baseline and once between days 14-21. Blood samples are collected at baseline, once between days 14-21, and at 4 weeks post-treatment for pharmacodynamic and other studies. Markers of angiogenesis (VEGF receptors, platelet-derived growth factor receptor, VEGF, sKIT, and tumor vascularity) are detected by immunohistochemistry. DCE-MRI and fludeoxyglucose F 18-PET are conducted for research studies at baseline and once between days 14-21.
After completion of study treatment, patients are followed at 4 weeks.