Conditions: Breast Cancer
Keywords: stage IA breast cancer stage IB breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 13
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Study to evaluate the effect of sunitinib (37.5 mg/day orally for 6 months) on occult tumor cells in the bone marrow of patients with high risk early stage breast cancer

Interventions: intervention 1: sunitinib malate intervention 2: flow cytometry intervention 3: immunohistochemistry staining method intervention 4: laboratory biomarker analysis
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol document: