Effect of Aromatase Inhibitor Therapy on Blood Vessel Function in Postmenopausal Women With Breast Cancer

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: assessment of therapy complications; Drug: anastrozole; Drug: exemestane; Drug: letrozole

• Registration Number: NCT00719966
• Lead Sponsor: Mayo Clinic

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.

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.

Study Timeline

• Study First Submitted: 2008-07-19
• Study First Submitted QC: 2008-07-19
• Study First Posted: 2008-07-22
• Study Start: 2008-09-18
• Primary Completion: 2013-06-13
• Study Completion: 2020-01-24
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-28
• Last Update Posted: 2024-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 109

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2 (hormone receptor-negative)	assessment of therapy complications	Patients do not receive adjuvant treatment.
Group 1 (hormone receptor-positive)	assessment of therapy complications	Patients receive aromatase inhibition therapy for up to 6 months in the absence of unacceptable toxicity.
Group 1 (hormone receptor-positive)	anastrozole	Patients receive aromatase inhibition therapy for up to 6 months in the absence of unacceptable toxicity.
Group 1 (hormone receptor-positive)	letrozole	Patients receive aromatase inhibition therapy for up to 6 months in the absence of unacceptable toxicity.
Group 1 (hormone receptor-positive)	exemestane	Patients receive aromatase inhibition therapy for up to 6 months in the absence of unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Endothelial dysfunction as a result of aromatase inhibitor therapy

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States