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

Breast Cancer Clinical Trial

Official title:

Effect of Aromatase Inhibitor Therapy for Breast Cancer on Endothelial Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00719966
• Other study ID #: MC0834
• Secondary ID: 06-004006
• Status: Completed
• Start date: September 18, 2008
• Est. completion date: January 24, 2020

Study information

• Verified date: December 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: January 24, 2020
• Est. primary completion date: June 13, 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• anastrozole
Patients receive aromatase inhibition therapy.
• exemestane
Patients receive aromatase inhibition therapy.
• letrozole
Patients receive aromatase inhibition therapy.

Procedure:
• assessment of therapy complications
Endothelial function is measured

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial dysfunction as a result of aromatase inhibitor therapy