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

Sponsor

Mayo Clinic (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00719966

Collaborator

National Cancer Institute (NCI) (NIH)

109

Enrollment

Location

172

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: anastrozole Drug: exemestane Drug: letrozole Procedure: assessment of therapy complications

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

Anticipated Enrollment :

109 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Effect of Aromatase Inhibitor Therapy for Breast Cancer on Endothelial Function

Actual Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Jun 13, 2013

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Group 1 (hormone receptor-positive) Patients receive aromatase inhibition therapy for up to 6 months in the absence of unacceptable toxicity.	Drug: anastrozole Patients receive aromatase inhibition therapy. Drug: exemestane Patients receive aromatase inhibition therapy. Drug: letrozole Patients receive aromatase inhibition therapy. Procedure: assessment of therapy complications Endothelial function is measured
Group 2 (hormone receptor-negative) Patients do not receive adjuvant treatment.	Procedure: assessment of therapy complications Endothelial function is measured

Arm

Intervention/Treatment

Group 1 (hormone receptor-positive)

Patients receive aromatase inhibition therapy for up to 6 months in the absence of unacceptable toxicity.

Drug: anastrozole

Patients receive aromatase inhibition therapy.

Drug: exemestane

Patients receive aromatase inhibition therapy.

Drug: letrozole

Patients receive aromatase inhibition therapy.

Procedure: assessment of therapy complications

Endothelial function is measured

Group 2 (hormone receptor-negative)

Patients do not receive adjuvant treatment.

Procedure: assessment of therapy complications

Endothelial function is measured

Outcome Measures

Primary Outcome Measures

Endothelial dysfunction as a result of aromatase inhibitor therapy []

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Diagnosis of breast cancer
Ductal carcinoma in situ (DCIS) allowed provided the patient will not receive tamoxifen as part of treatment for their cancer
May not have had a prior mastectomy with requirement for mastectomy of the contralateral breast
No requirement for axillary lymph node dissection with a history of contralateral mastectomy and/or contralateral axillary lymph node dissection
Hormone receptor status meeting 1 of the following criteria:
Hormone receptor negative and not eligible for aromatase inhibitor therapy (AI)
Hormone receptor positive and are not receiving an AI

PATIENT CHARACTERISTICS:

Postmenopausal
No known or symptomatic coronary artery disease
No significant co-morbidities, including any of the following conditions:
Active renal or hepatic disease
Known uncontrolled and/or untreated peripheral arterial disease
Uncontrolled and/or untreated hypertension
Uncontrolled and/or untreated diabetes
Uncontrolled and/or untreated hyperlipidemia

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
More than 7 days since prior hormone replacement therapy or hormone-based contraception
More than 12 months since prior and no concurrent tamoxifen or aromatase inhibitor therapy for this disease
More than 12 months since prior and no concurrent chemotherapy for this disease
No prior bilateral mastectomy