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Sponsored by: |
National Cancer Institute of Canada |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00482755 |
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. Giving sunitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with newly diagnosed stage II or stage IIIA breast cancer that can be removed by surgery.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: sunitinib malate Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: needle biopsy Procedure: neoadjuvant therapy Procedure: pharmacological study |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Feasibility Study of Pre-Operative Sunitinib (SU11248) With Multiple Pharmacodynamic Endpoints in Patients With T1c-T3 Operable Carcinoma of the Breast |
Estimated Enrollment: | 48 |
Study Start Date: | March 2007 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral sunitinib malate once daily for 14-21 days in the absence of disease progression or unacceptable toxicity.
Tissue samples are obtained by needle biopsy at baseline and once between days 14-21. Blood samples are collected at baseline, once between days 14-21, and at 4 weeks post-treatment for pharmacodynamic and other studies. Markers of angiogenesis (VEGF receptors, platelet-derived growth factor receptor, VEGF, sKIT, and tumor vascularity) are detected by immunohistochemistry. DCE-MRI and fludeoxyglucose F 18-PET are conducted for research studies at baseline and once between days 14-21.
After completion of study treatment, patients are followed at 4 weeks.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer
PATIENT CHARACTERISTICS:
No serious illness or medical condition that would preclude study compliance including, but not limited to, the following:
PRIOR CONCURRENT THERAPY:
At least 7 days since prior and no concurrent CYP3A4 inhibitors, including the following:
At least 12 days since prior and no concurrent CYP3A4 inducers, including the following:
No concurrent coumadin-derivative anticoagulants (e.g., warfarin)
Canada, British Columbia | |
British Columbia Cancer Agency - Vancouver Cancer Centre | Recruiting |
Vancouver, British Columbia, Canada, V5Z 4E6 | |
Contact: Stephen Chia 604-877-6000 | |
Canada, Ontario | |
Edmond Odette Cancer Centre at Sunnybrook | Recruiting |
Toronto, Ontario, Canada, M4N 3M5 | |
Contact: Maureen E. Trudeau 416-480-5145 |
Study Chair: | Maureen E. Trudeau, BSc, MA, MD, FRCPC | Edmond Odette Cancer Centre at Sunnybrook |
Study ID Numbers: | CDR0000547161, CAN-NCIC-MA29, PFIZER-CAN-NCIC-MA29 |
Study First Received: | June 4, 2007 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00482755 |
Health Authority: | Unspecified |
male breast cancer stage II breast cancer stage IIIA breast cancer |
Skin Diseases Breast Neoplasms, Male Sunitinib |
Breast Neoplasms Breast Diseases Carcinoma |
Neoplasms Neoplasms by Site Antineoplastic Agents Growth Substances Therapeutic Uses |
Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |