Effect of Aromatase Inhibitor Therapy on Blood Vessel Function in Postmenopausal Women With Breast Cancer
NCT ID: NCT00719966
Last Updated: 2024-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
109 participants
OBSERVATIONAL
2008-09-18
2020-01-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: This clinical trial is studying the effect of aromatase inhibitor therapy on blood vessel function in postmenopausal women with breast cancer.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Aromatase Inhibitor Clinical Trial
NCT00228956
A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer
NCT02246621
Chronic Impacts of Endocrine Therapy on Cardiovascular and Brain Health Outcomes in Breast Cancer
NCT06776458
Changes in Breast Density and Blood Hormone Levels in Postmenopausal Women Receiving Anastrozole or Exemestane for Breast Cancer
NCT00516698
Letrozole in Preventing Breast Cancer in Postmenopausal Women
NCT00090857
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1 (hormone receptor-positive)
Patients receive aromatase inhibition therapy for up to 6 months in the absence of unacceptable toxicity.
anastrozole
Patients receive aromatase inhibition therapy.
exemestane
Patients receive aromatase inhibition therapy.
letrozole
Patients receive aromatase inhibition therapy.
assessment of therapy complications
Endothelial function is measured
Group 2 (hormone receptor-negative)
Patients do not receive adjuvant treatment.
assessment of therapy complications
Endothelial function is measured
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
anastrozole
Patients receive aromatase inhibition therapy.
exemestane
Patients receive aromatase inhibition therapy.
letrozole
Patients receive aromatase inhibition therapy.
assessment of therapy complications
Endothelial function is measured
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
40 Years
80 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Mayo Clinic
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nicole P. Sandhu, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic
Rochester, Minnesota, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
06-004006
Identifier Type: OTHER
Identifier Source: secondary_id
MC0834
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.