Sunitinib in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer Who Have Tumor Cells in the Bone Marrow

Phase 2

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: sunitinib malate; Other: flow cytometry; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis

• Registration Number: NCT00824538
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study First Submitted: 2009-01-15
• Study First Submitted QC: 2009-01-15
• Study First Posted: 2009-01-16
• Study Start: 2009-02
• Primary Completion: 2010-11-10
• Results First Submitted: 2013-03-01
• Study Completion: 2013-12
• Results First Submitted QC: 2014-04-10
• Results First Posted: 2014-05-08
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-09
• Last Update Posted: 2018-04-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sunitinib	flow cytometry	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
sunitinib	laboratory biomarker analysis	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
sunitinib	immunohistochemistry staining method	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
sunitinib	sunitinib malate	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

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Disseminated Tumor Cells (DTC) in Bone Marrow	Baseline, 6 months after start of treatment	DTCs were detected by immunomagnetic enrichment and flow cytometry (IE/FC) and measured in cells/mL

Secondary Outcome Measures

Name	Time	Method
Number of Patients Who Are Able to Tolerate Sunitinib Malate for 6 Months and Complete the Study	after 6 months from start of treatment
Participants Affected by Toxicities as Assessed by NCI CTCAE v3.0	up to 7 months after start of treatment
Relapse-free and Overall Survival	up to 3 years from beginning of treatment	Data was not collected due to emerging data on toxicity and competing trials.
Effect of Sunitinib Malate on OTC in Peripheral Blood	After one year of treatment	Data was not collected due to emerging data on toxicity and competing trials.