Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-29 @ 9:41 PM
Study NCT ID:
NCT00719966
Status:
COMPLETED
Last Update Posted:
2024-01-02
First Post:
2008-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Aromatase Inhibitor Therapy on Blood Vessel Function in Postmenopausal Women With Breast Cancer
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Effect of Aromatase Inhibitor Therapy for Breast Cancer on Endothelial Function
Status:
COMPLETED
Status Verified Date:
2023-12
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: Aromatase inhibitor therapy is used in treating postmenopausal women who have hormone-dependent breast cancer. It is not yet known what effect aromatase inhibitor therapy has on blood vessel function.
PURPOSE: This clinical trial is studying the effect of aromatase inhibitor therapy on blood vessel function in postmenopausal women with breast cancer.
PURPOSE: This clinical trial is studying the effect of aromatase inhibitor therapy on blood vessel function in postmenopausal women with breast cancer.
Detailed Description:
OBJECTIVES:
* Determine the effect of adjuvant aromatase inhibitor therapy on endothelial function in postmenopausal women with breast cancer.
OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 treatment groups according to breast cancer hormone-receptor status (positive vs negative).
* Group 1 (hormone receptor-positive): Patients receive aromatase inhibition therapy for up to 6 months in the absence of unacceptable toxicity.
* Group 2 (hormone receptor-negative): Patients do not receive adjuvant treatment.
Endothelial function is measured in both groups at baseline and at follow up by the room temperature peripheral arterial tonometry (RT-PAT) index using the EndoPAT method.
* Determine the effect of adjuvant aromatase inhibitor therapy on endothelial function in postmenopausal women with breast cancer.
OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 treatment groups according to breast cancer hormone-receptor status (positive vs negative).
* Group 1 (hormone receptor-positive): Patients receive aromatase inhibition therapy for up to 6 months in the absence of unacceptable toxicity.
* Group 2 (hormone receptor-negative): Patients do not receive adjuvant treatment.
Endothelial function is measured in both groups at baseline and at follow up by the room temperature peripheral arterial tonometry (RT-PAT) index using the EndoPAT method.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 06-004006 | OTHER | Mayo Clinic IRB | View |