Breast Cancer Clinical Trial
Official title:
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
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.
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
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