Sunitinib in Treating Patients With Newly Diagnosed Stage II or Stage III Breast Cancer That Can Be Removed by Surgery
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.
Drug: sunitinib malate
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: pharmacological study
Procedure: needle biopsy
Procedure: neoadjuvant therapy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Feasibility Study of Pre-Operative Sunitinib (SU11248) With Multiple Pharmacodynamic Endpoints in Patients With T1c-T3 Operable Carcinoma of the Breast|
- Feasibility [ Designated as safety issue: No ]
- Nature, severity, and frequency of adverse events [ Designated as safety issue: Yes ]
- Activity (response rate) [ Designated as safety issue: No ]
- Markers of angiogenesis pre- and post-treatment [ Designated as safety issue: No ]
- Role of both host- and tumor-specific genes pertaining to response and toxicity [ Designated as safety issue: Yes ]
- Comparison of tumor vascular parameters pre- and post-treatment [ Designated as safety issue: No ]
- Comparison of cell death and tumor microcirculation pre- and post-treatment [ Designated as safety issue: No ]
- Comparison of tumor metabolic activity pre- and post-treatment [ Designated as safety issue: No ]
|Study Start Date:||March 2007|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
- Determine the feasibility of neoadjuvant sunitinib malate in patients with newly diagnosed, resectable stage II-IIIA breast cancer.
- Determine the nature, severity, and frequency of adverse events in patients treated with this drug.
- Determine the response rate in patients treated with this drug.
- Evaluate markers of angiogenesis (e.g., VEGF receptor, platelet-derived growth factor receptor, circulating plasma VEGF, sVEGFR-2, sVEGFR-3, sKIT, and tumor vascularity) both pre- and post-treatment.
- Examine the role of both host- and tumor-specific genes pertaining to response and toxicity.
- Compare tumor vascular parameters pre- and post-treatment using DCE-MRI.
- Compare cell death and tumor microcirculation pre- and post-treatment using contrast-enhanced spectroscopic and microbubble contrast-enhanced ultrasound.
- Compare tumor metabolic activity pre- and post-treatment using fludeoxyglucose F 18-PET.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00482755
|Canada, British Columbia|
|British Columbia Cancer Agency - Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Edmond Odette Cancer Centre at Sunnybrook|
|Toronto, Ontario, Canada, M4N 3M5|
|Study Chair:||Maureen E. Trudeau, BSc, MA, MD, FRCPC||Edmond Odette Cancer Centre at Sunnybrook|