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

Sponsor:	Mayo Clinic
Collaborator:	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: assessment of therapy complications

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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Exemestane Letrozole Anastrozole

U.S. FDA Resources

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. Procedure: assessment of therapy complications Endothelial function is measured
Group 2 (hormone receptor-negative): No Intervention Patients do not receive adjuvant treatment.	Procedure: assessment of therapy complications Endothelial function is measured

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.

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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

Locations

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

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000595404, MAYO-MC0834
Study First Received:	July 19, 2008
Last Updated:	December 24, 2009
ClinicalTrials.gov Identifier:	NCT00719966 History of Changes
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
ductal breast carcinoma in situ

Additional relevant MeSH terms:

Anastrozole
Antineoplastic Agents, Hormonal
Skin Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Breast Neoplasms
Letrozole
Enzyme Inhibitors

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Exemestane
Aromatase Inhibitors
Breast Diseases

ClinicalTrials.gov processed this record on February 08, 2010