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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Percent Change From Baseline in Disseminated Tumor Cells (DTC) in Bone Marrow
DTCs were detected by immunomagnetic enrichment and flow cytometry (IE/FC) and measured in cells/mL
Time frame: Baseline, 6 months after start of treatment
Number of Patients Who Are Able to Tolerate Sunitinib Malate for 6 Months and Complete the Study
Time frame: after 6 months from start of treatment
Participants Affected by Toxicities as Assessed by NCI CTCAE v3.0
Time frame: up to 7 months after start of treatment
Relapse-free and Overall Survival
Data was not collected due to emerging data on toxicity and competing trials.
Time frame: up to 3 years from beginning of treatment
Effect of Sunitinib Malate on OTC in Peripheral Blood
Data was not collected due to emerging data on toxicity and competing trials.
Time frame: After one year of treatment
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