Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00201773
Status:
COMPLETED
Last Update Posted:
2015-06-30
First Post:
2005-09-12
Brief Title:
Exemestane With Celecoxib as Neoadjuvant Treatment in Postmenopausal Women With Stage II III and IV Breast Cancer
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
A Phase II Trial of Exemestane Aromasin in Combination With Celecoxib Celebrex as Neoadjuvant Treatment in Postmenopausal Women With Stage II III and IV Breast Cancer
Status:
COMPLETED
Status Verified Date:
2015-06
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:
To test whether the addition of the COX-2 inhibitor celecoxib will decrease the gene expression of CYP19 in breast cancers collected from postmenopausal women that receive neoadjuvant exemestane
Detailed Description:
Rationale In postmenopausal women the main source of estrogen is through the conversion of androgens or sex hormones produced by the adrenal glands An enzyme called aromatase carries out this process Exemestane an aromatase inhibitor blocks production of estrogens Research indicates that the gene responsible for aromatase activity is CYPO19 Therefore exemestane helps to inhibit aromatase activity through CYP019 Along with CYP019 another gene associated with breast cancer is an overexpression of COX-2 enzymes Research suggests that COX-2 overexpression can cause cancer cell division increased blood flow to tumors and metastases Celecoxib blocks COX-2 activity and produces fewer side effects compared with other non-steroidal inflammatory drugs NSAIDs This study builds on previous research to test the combination of exemestane and celecoxib for breast cancer
Purpose This study is evaluating the safety and efficacy of exemestane and celecoxib before surgery for stage II III and IV breast cancer in postmenopausal women Tests will analyze the CYP019 gene after these treatments
Treatment Patients in this study will receive exemestane and celecoxib Both drugs will be given to patients as oral pills Exemestane will be taken daily for sixteen weeks Starting in week 9 celecoxib will be taken twice daily for eight weeks Therefore during weeks 9-16 patients will be taking both exemestane and celecoxib Several tests and exams will be given throughout the study to closely monitor patients including a biopsy performed after the first 8 weeks on exemestane After sixteen weeks on exemestane and celecoxib patients will have breast surgery
Purpose This study is evaluating the safety and efficacy of exemestane and celecoxib before surgery for stage II III and IV breast cancer in postmenopausal women Tests will analyze the CYP019 gene after these treatments
Treatment Patients in this study will receive exemestane and celecoxib Both drugs will be given to patients as oral pills Exemestane will be taken daily for sixteen weeks Starting in week 9 celecoxib will be taken twice daily for eight weeks Therefore during weeks 9-16 patients will be taking both exemestane and celecoxib Several tests and exams will be given throughout the study to closely monitor patients including a biopsy performed after the first 8 weeks on exemestane After sixteen weeks on exemestane and celecoxib patients will have breast surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None