A Feasibility Study of Pre-Operative Sunitinib (SU11248) With Multiple Pharmacodynamic Endpoints in Patients With T1c-T3 Operable Carcinoma of the Breast
- Determine the feasibility of neoadjuvant sunitinib malate in patients with newly
diagnosed, resectable stage II-IIIA breast cancer.
- 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
- 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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maureen E. Trudeau, BSc, MA, MD, FRCPC
Edmond Odette Cancer Centre at Sunnybrook
Canada: Health Canada