Effect of Aromatase Inhibitor Therapy for Breast Cancer on Endothelial Function
Overview
- Phase
- Not Applicable
- Intervention
- letrozole
- Conditions
- Breast Cancer
- Sponsor
- Mayo Clinic
- Enrollment
- 109
- Locations
- 1
- Primary Endpoint
- Endothelial dysfunction as a result of aromatase inhibitor therapy
- Status
- Completed
- Last Updated
- 2 years ago
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.
Investigators
Eligibility Criteria
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
Group 1 (hormone receptor-positive)
Patients receive aromatase inhibition therapy for up to 6 months in the absence of unacceptable toxicity.
Intervention: anastrozole
Group 1 (hormone receptor-positive)
Patients receive aromatase inhibition therapy for up to 6 months in the absence of unacceptable toxicity.
Intervention: exemestane
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
Group 2 (hormone receptor-negative)
Patients do not receive adjuvant treatment.
Intervention: assessment of therapy complications
Outcomes
Primary Outcomes
Endothelial dysfunction as a result of aromatase inhibitor therapy