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Sponsors and Collaborators: |
UCSF Helen Diller Family Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00824538 |
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.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: sunitinib malate Other: flow cytometry Other: immunohistochemistry staining method Other: laboratory biomarker analysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
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 |
Estimated Enrollment: | 45 |
Study Start Date: | February 2009 |
Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed high-risk breast cancer
Has undergone definitive surgery with or without radiotherapy
Bone marrow aspirate positive for occult tumor cells, defined as ≥ 10 occult tumor cells/mL by IHC and flow cytometry
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Responsible Party: | UCSF Helen Diller Family Comprehensive Cancer Center ( Hope S. Rugo ) |
Study ID Numbers: | CDR0000632345, UCSF-077539 |
Study First Received: | January 15, 2009 |
Last Updated: | February 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00824538 History of Changes |
Health Authority: | Unspecified |
stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
Skin Diseases Sunitinib Breast Neoplasms Angiogenesis Inhibitors Breast Diseases |
Skin Diseases Antineoplastic Agents Growth Substances Physiological Effects of Drugs Breast Neoplasms Angiogenesis Inhibitors Pharmacologic Actions |
Neoplasms Neoplasms by Site Sunitinib Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Breast Diseases |