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

Effect of Aromatase Inhibitor Therapy for Breast Cancer on Endothelial Function

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00719966
Enrollment
109
Registered
2008-07-22
Start date
2008-09-18
Completion date
2020-01-24
Last updated
2024-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, ductal breast carcinoma in situ

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.

Interventions

DRUGanastrozole

Patients receive aromatase inhibition therapy.

DRUGexemestane

Patients receive aromatase inhibition therapy.

DRUGletrozole

Patients receive aromatase inhibition therapy.

PROCEDUREassessment of therapy complications

Endothelial function is measured

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Endothelial dysfunction as a result of aromatase inhibitor therapy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026