Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-29 @ 6:00 AM
Study NCT ID:
NCT00931450
Status:
UNKNOWN
Last Update Posted:
2013-08-12
First Post:
2009-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sunitinib Malate and Exemestane in Treating Postmenopausal Women With Breast Cancer
Sponsor:
Institut Català d'Oncologia
Organization:
Study Overview
Official Title:
Pilot / Phase II Randomised, Double Blind, Placebo Controlled Multicenter Study With Biomarker Evaluation of Neoadjuvant Exemestane in Combination With Sunitinib in Post-menopausal Women With Hormone- Sensitive, Her-2 Negative Primary Breast Cancer.
Status:
UNKNOWN
Status Verified Date:
2009-07
Last Known Status:
RECRUITING
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 malate and exemestane may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving sunitinib malate and exemestane before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of sunitinib malate to see how well it works when given together with exemestane in treating postmenopausal women with breast cancer.
PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of sunitinib malate to see how well it works when given together with exemestane in treating postmenopausal women with breast cancer.
Detailed Description:
OBJECTIVES:
Primary
* Determine the safe dose level of sunitinib malate that can be combined with exemestane (pilot phase I).
* Evaluate the clinical response of neoadjuvant therapy comprising exemestane and sunitinib malate in postmenopausal women with hormone receptor-positive and HER-2 negative primary breast cancer (phase II).
Secondary
* Evaluate the safety and feasibility of this regimen in these patients.
* Evaluate the percentage of patients undergoing breast-conserving surgery after completion of study therapy.
* Determine the safety profile of this regimen in these patients.
* Determine the rate of complete pathological response in the breast and axillary lymph nodes at the time of surgery.
* Determine the extent of treatment-related inhibition of phosphorylation of VEGFR-2, PDGF, and c-KIT receptor tyrosine kinases.
* Find a genetic profile, based on the analysis of CYP19A1 polymorphisms, able to predict response to exemestane in neoadjuvant setting.
* Conduct exploratory investigation of biomarkers expression before and during therapy in order to identify molecular characteristics of responding tumors.
OUTLINE: This is a multicenter, dose-escalation study of sunitinib malate followed by a phase II study.
* Phase I pilot: Patients receive oral sunitinib malate and oral exemestane once daily on days 1-28. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
* Phase II: Patients are randomized to 1 of 2 treatment groups:
* Group 1: Patients receive oral exemestane and oral placebo once daily on days 1-28. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
* Group 2: Patients receive oral exemestane once daily and oral sunitinib malate once daily on days 1-28. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
At 7-15 days after completion of study therapy, patients undergo definitive surgery.
Blood and tissue samples are collected at baseline and periodically during study to examine inhibition of phosphorylation of VEGFR-2, PDGF, and c-KIT receptor tyrosine kinases; CYP19A1 polymorphisms; and biomarkers analysis by cDNA microarrays, ELISA, and RT-PCR.
Primary
* Determine the safe dose level of sunitinib malate that can be combined with exemestane (pilot phase I).
* Evaluate the clinical response of neoadjuvant therapy comprising exemestane and sunitinib malate in postmenopausal women with hormone receptor-positive and HER-2 negative primary breast cancer (phase II).
Secondary
* Evaluate the safety and feasibility of this regimen in these patients.
* Evaluate the percentage of patients undergoing breast-conserving surgery after completion of study therapy.
* Determine the safety profile of this regimen in these patients.
* Determine the rate of complete pathological response in the breast and axillary lymph nodes at the time of surgery.
* Determine the extent of treatment-related inhibition of phosphorylation of VEGFR-2, PDGF, and c-KIT receptor tyrosine kinases.
* Find a genetic profile, based on the analysis of CYP19A1 polymorphisms, able to predict response to exemestane in neoadjuvant setting.
* Conduct exploratory investigation of biomarkers expression before and during therapy in order to identify molecular characteristics of responding tumors.
OUTLINE: This is a multicenter, dose-escalation study of sunitinib malate followed by a phase II study.
* Phase I pilot: Patients receive oral sunitinib malate and oral exemestane once daily on days 1-28. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
* Phase II: Patients are randomized to 1 of 2 treatment groups:
* Group 1: Patients receive oral exemestane and oral placebo once daily on days 1-28. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
* Group 2: Patients receive oral exemestane once daily and oral sunitinib malate once daily on days 1-28. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
At 7-15 days after completion of study therapy, patients undergo definitive surgery.
Blood and tissue samples are collected at baseline and periodically during study to examine inhibition of phosphorylation of VEGFR-2, PDGF, and c-KIT receptor tyrosine kinases; CYP19A1 polymorphisms; and biomarkers analysis by cDNA microarrays, ELISA, and RT-PCR.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: