Sunitinib in Treating Patients With Newly Diagnosed Stage II or Stage III Breast Cancer That Can Be Removed by Surgery
Tracking Information | |||||
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First Received Date ICMJE | June 4, 2007 | ||||
Last Updated Date | January 18, 2011 | ||||
Start Date ICMJE | March 2007 | ||||
Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Feasibility [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE |
Feasibility | ||||
Change History | Complete list of historical versions of study NCT00482755 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Sunitinib in Treating Patients With Newly Diagnosed Stage II or Stage III Breast Cancer That Can Be Removed by Surgery | ||||
Official Title ICMJE | A Feasibility Study of Pre-Operative Sunitinib (SU11248) With Multiple Pharmacodynamic Endpoints in Patients With T1c-T3 Operable Carcinoma of the Breast | ||||
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. 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. |
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Detailed Description | 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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Breast Cancer | ||||
Intervention ICMJE |
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Study Arm (s) | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 4 | ||||
Completion Date | January 2011 | ||||
Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Canada | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00482755 | ||||
Other Study ID Numbers ICMJE | MA29, CAN-NCIC-MA29, PFIZER-CAN-NCIC-MA29, CDR0000547161 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Ralph Meyer, M.D., NCIC Clinical Trials Group | ||||
Study Sponsor ICMJE | NCIC Clinical Trials Group | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | NCIC Clinical Trials Group | ||||
Verification Date | January 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |