Effect of Aromatase Inhibitor Therapy for Breast Cancer on Endothelial Function
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 109
- Locations
- 1
- Primary Endpoint
- Endothelial dysfunction as a result of aromatase inhibitor therapy
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Group 1 (hormone receptor-positive)
Patients receive aromatase inhibition therapy for up to 6 months in the absence of unacceptable toxicity.
Intervention: letrozole (Drug)
Group 1 (hormone receptor-positive)
Patients receive aromatase inhibition therapy for up to 6 months in the absence of unacceptable toxicity.
Intervention: anastrozole (Drug)
Group 1 (hormone receptor-positive)
Patients receive aromatase inhibition therapy for up to 6 months in the absence of unacceptable toxicity.
Intervention: exemestane (Drug)
Group 1 (hormone receptor-positive)
Patients receive aromatase inhibition therapy for up to 6 months in the absence of unacceptable toxicity.
Intervention: assessment of therapy complications (Procedure)
Group 2 (hormone receptor-negative)
Patients do not receive adjuvant treatment.
Intervention: assessment of therapy complications (Procedure)
Outcomes
Primary Outcomes
Endothelial dysfunction as a result of aromatase inhibitor therapy
Secondary Outcomes
No secondary outcomes reported