Status: Closed
Activation Date: 2007MAR12
Closing Date: 2010MAR15
Phase: II
Description: A Feasibility Study of Pre-Operative Sunitinib (SU11248) With Multiple Pharmacodynamic Endpoints in Patients with T1c-T3 Operable Carcinoma of the Breast.
Eligibility: Women with newly diagnosed, histopathologically confirmed, T1c, T2 or T3 unifocal, operable, carcinoma of the breast (prior to surgery).
Objective: PRIMARY: To assess the feasibility of administering oral sunitinib pre-operatively, to patients with newly diagnosed, histopathologically confirmed T1c, T2 or T3 unifocal, operable carcinoma of the breast. SECONDARY: - toxicity - tumour response (RECIST) - pharmacodynamic endpoints [treatment-induced changes (1) in the levels of tumour and plasma-soluble markers of angiogenesis, (2) in the protein/RNA levels of host and tumour-specific genes involved in response and toxicity to sunitinib, (3) on vascular parameters (DCE-MRI), (4) on cell death and tumour microcirculation (spectroscopic and microbubble contrast-enhanced ultrasound) and (5) on tumour metabolic activity (18-FDG-PET)] - tumour banking (optional)
Participation: Limited to invited centres
Lay Description: The purpose of this study is to investigate the effects of sunitinib when given to women with locally-advanced, operable breast cancer, prior to surgery. This study is being done because researchers are trying to get a better understanding of exactly how sunitinib works and how it affects the formation of blood vessels on breast tumours.
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Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| BREAST | MA29 | 4 | 4 | 0 | 4 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| BREAST | MA29 | 4 | 0 | 0 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| BREAST | MA29 | 4 | 4 | 0 | 0 | 0 | 4 | 4 | 0 | 0 |