Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00482755
Status:
COMPLETED
Last Update Posted:
2024-02-12
First Post:
2007-06-04
Brief Title:
Sunitinib in Treating Patients With Newly Diagnosed Stage II or Stage III Breast Cancer That Can Be Removed by Surgery
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Feasibility Study of Pre-Operative Sunitinib SU11248 With Multiple Pharmacodynamic Endpoints in Patients With T1c-T3 Operable Carcinoma of the Breast
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
OBJECTIVES
Primary
Determine the feasibility of neoadjuvant sunitinib malate in patients with newly diagnosed resectable stage II-IIIA breast cancer
Secondary
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 eg 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
Primary
Determine the feasibility of neoadjuvant sunitinib malate in patients with newly diagnosed resectable stage II-IIIA breast cancer
Secondary
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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000547161 | OTHER | PDQ | None |
| CAN-NCIC-MA29 | OTHER | None | None |
| PFIZER-CAN-NCIC-MA29 | OTHER | None | None |