Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00073073
Status:
COMPLETED
Last Update Posted:
2016-05-17
First Post:
2003-11-14
Brief Title:
Exemestane and Celecoxib in Postmenopausal Women at High Risk for Breast Cancer
Sponsor:
Georgetown University
Organization:
Georgetown University
Study Overview
Official Title:
A Trial of Exemestane in Postmenopausal Women With DCIS or at High Risk for Invasive Breast Cancer
Status:
COMPLETED
Status Verified Date:
2015-10
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:
The primary goal of this 5-year study is to determine whether exemestane alone or in combination with celecoxib decreases breast tissue density in healthy postmenopausal women at high risk for breast cancer Dense breast tissue seen on mammography has been linked to an increased risk of breast cancer The study will also examine the effects of exemestane and celecoxib on bone density blood hormone levels and quality of life Exemestane approved by the Food and Drug Administration for treating postmenopausal women with breast cancer lowers the amount of estrogen in the body Celecoxib approved for treating arthritis pain and for reducing the number or colon polyps in an inherited syndrome is an anti-inflammatory drug Half of the women in the study will receive exemestane alone and half will receive exemestane and celecoxib together
In December 2004 the arm using exemestane and celecoxib was closed to accrual
Postmenopausal women who are at increased risk for developing invasive breast cancer may be eligible to participate Candidates are screened with breast cancer risk assessment medical history and physical examination blood tests review of medical records if needed breast biopsy and dual energy x-ray absorptiometry DEXA scan to assess bone density For the DEXA scan the subject lies still on a table for about 30 minutes while the spine and hip are scanned using a small amount of radiation
Participants take exemestane in pill form once a day for 2 years They also take calcium and vitamin D pills daily to help protect bone health They are followed in the clinic during the course of the study to determine the amount of drug taken and any side effects and for the following tests and procedures
Medical evaluation and blood tests at after 1 and 3 months on study drugs
Medical evaluation at 6 months
Breast biopsy at screening and then at 12 months
dual-emission x-ray absorptiometry DEXA scan of the spine mammogram and routine blood tests before starting study drugs and then yearly for 5 years
In December 2004 the arm using exemestane and celecoxib was closed to accrual
Postmenopausal women who are at increased risk for developing invasive breast cancer may be eligible to participate Candidates are screened with breast cancer risk assessment medical history and physical examination blood tests review of medical records if needed breast biopsy and dual energy x-ray absorptiometry DEXA scan to assess bone density For the DEXA scan the subject lies still on a table for about 30 minutes while the spine and hip are scanned using a small amount of radiation
Participants take exemestane in pill form once a day for 2 years They also take calcium and vitamin D pills daily to help protect bone health They are followed in the clinic during the course of the study to determine the amount of drug taken and any side effects and for the following tests and procedures
Medical evaluation and blood tests at after 1 and 3 months on study drugs
Medical evaluation at 6 months
Breast biopsy at screening and then at 12 months
dual-emission x-ray absorptiometry DEXA scan of the spine mammogram and routine blood tests before starting study drugs and then yearly for 5 years
Detailed Description:
Background
Evidence from adjuvant treatment trials of invasive breast cancer with aromatase inhibitors suggests that these agents are superior to tamoxifen in preventing contralateral breast cancer and are well tolerated These agents are promising breast cancer chemopreventive agents Data on safety and effect on surrogate biomarkers in a healthy at risk population is lacking
Objectives
Primary
-The primary objective is to evaluate the study drug effects on mammographic density after one year on treatment
Secondary
-Secondary objectives include assessing the effect of the intervention on bone mineral density serum hormones and lipids and breast tissue biomarkers
Eligibility
Eligible patients are postmenopausal women who meet one of the following criteria
History of stage I or II breast cancer 2 years out from definitive therapy
Gail model 5 year risk greater than or equal to 17
History of treated ductal carcinoma in-situ DCIS
History of high risk lesion on breast biopsy atypical ductal hyperplasia ADH atypical lobular hyperplasia ALH lobular carcinoma in-situ LCIS
Known or suspected breast cancer 1 early onset BRCA1 or breasts cancer 2 early onset BRCA2 mutation
Subjects must have adequate bone mineral density by dual-emission x-ray absorptiometry DEXA scan in order to enroll
Design
This is an open label study of exemestane in postmenopausal women with an elevated risk of developing invasive breast cancer Forty five subjects will be enrolled and receive standard dose exemestane 25 mg each day QD calcium and vitamin D
Each subject will continue treatment for a total of two years
Changes in mammographic breast density and bone mineral density will be evaluated annually which will provide long term biomarker and safety information about prevention therapy with exemestane
Evidence from adjuvant treatment trials of invasive breast cancer with aromatase inhibitors suggests that these agents are superior to tamoxifen in preventing contralateral breast cancer and are well tolerated These agents are promising breast cancer chemopreventive agents Data on safety and effect on surrogate biomarkers in a healthy at risk population is lacking
Objectives
Primary
-The primary objective is to evaluate the study drug effects on mammographic density after one year on treatment
Secondary
-Secondary objectives include assessing the effect of the intervention on bone mineral density serum hormones and lipids and breast tissue biomarkers
Eligibility
Eligible patients are postmenopausal women who meet one of the following criteria
History of stage I or II breast cancer 2 years out from definitive therapy
Gail model 5 year risk greater than or equal to 17
History of treated ductal carcinoma in-situ DCIS
History of high risk lesion on breast biopsy atypical ductal hyperplasia ADH atypical lobular hyperplasia ALH lobular carcinoma in-situ LCIS
Known or suspected breast cancer 1 early onset BRCA1 or breasts cancer 2 early onset BRCA2 mutation
Subjects must have adequate bone mineral density by dual-emission x-ray absorptiometry DEXA scan in order to enroll
Design
This is an open label study of exemestane in postmenopausal women with an elevated risk of developing invasive breast cancer Forty five subjects will be enrolled and receive standard dose exemestane 25 mg each day QD calcium and vitamin D
Each subject will continue treatment for a total of two years
Changes in mammographic breast density and bone mineral density will be evaluated annually which will provide long term biomarker and safety information about prevention therapy with exemestane
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-C-0044 | OTHER | NCI | None |