Pilot Study to Evaluate the Effect of Sunitinib on Occult Tumor Cells in the Bone Marrow of Patients With High Risk Early Stage Breast Cancer
- To determine the effect of sunitinib malate on occult tumor cells (OTC) in the bone
marrow of patients with high-risk stage I-III breast cancer.
- To evaluate the number of patients who are able to tolerate this drug for 6 months and
complete the study.
- To evaluate the toxicities of this drug in these patients.
- To evaluate the effects of this drug on OTC in peripheral blood.
- To evaluate correlative markers, including endothelial cells, soluble cKIT, and VEGF.
- To evaluate relapse-free and overall survival of patients treated with this drug.
OUTLINE: Patients receive oral sunitinib malate once daily for 6 months in the absence of
disease progression or unacceptable toxicity.
Patients undergo bone marrow aspiration and peripheral blood sample collection at baseline
and at 6 and 12 months. Bone marrow aspirate samples are analyzed by IHC and flow cytometry.
Peripheral blood samples are analyzed for circulating tumor cells.
After completion of study treatment, patients are followed at 1 and 6 months.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Effect of sunitinib malate on occult tumor cells (OTC) in bone marrow
Hope S. Rugo, MD
University of California, San Francisco
United States: Food and Drug Administration