Effect of Aromatase Inhibitor Therapy on Blood Vessel Function in Postmenopausal Women With Breast Cancer - Full Text View

Sponsors and Collaborators:	Mayo Clinic National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00719966

Purpose

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	Intervention
Breast Cancer	Drug: anastrozole Drug: exemestane Drug: letrozole Procedure: observation

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Anastrozole Letrozole Exemestane

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Effect of Aromatase Inhibitor Therapy for Breast Cancer on Endothelial Function

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Endothelial dysfunction as a result of aromatase inhibitor therapy [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	June 2008
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1 (hormone receptor-positive): Experimental 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.
Group 2 (hormone receptor-negative): No Intervention Patients do not receive adjuvant treatment.	Procedure: observation Patients undergo observation.

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 6 months after completion of study therapy by the room temperature peripheral arterial tonometry (RT-PAT) index using the EndoPAT method.

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of breast cancer
May not have had a prior mastectomy with requirement for mastectomy of the contralateral breast
Hormone receptor status known

PATIENT CHARACTERISTICS:

Postmenopausal
No known or symptomatic coronary artery disease
No significant co-morbidities, including any of the following conditions:
- Renal or hepatic disease
- Known 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 3 months since prior hormone replacement therapy or hormone-based contraception
No prior tamoxifen or aromatase inhibitor therapy
No prior bilateral mastectomy
No prior or concurrent chemotherapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719966

Locations

United States, Arizona
Mayo Clinic Scottsdale	Recruiting
Scottsdale, Arizona, United States, 85259-5499
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
United States, Florida
Mayo Clinic - Jacksonville	Recruiting
Jacksonville, Florida, United States, 32224
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
United States, Minnesota
Mayo Clinic Cancer Center	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623

Sponsors and Collaborators

Mayo Clinic

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Nicole P. Sandhu, MD, PhD

Mayo Clinic

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000595404, MAYO-MC0834
Study First Received:	July 19, 2008
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00719966
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer

Study placed in the following topic categories:

Anastrozole
Skin Diseases
Breast Neoplasms

Letrozole
Exemestane
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents, Hormonal
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Aromatase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009