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

This study is currently recruiting participants.
Verified April 2012 by Mayo Clinic
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00719966
First received: July 19, 2008
Last updated: April 20, 2012
Last verified: April 2012
History of Changes
  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: Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Aromatase Inhibitor Therapy for Breast Cancer on Endothelial Function

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

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 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 (hormone receptor-positive)
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
No Intervention: Group 2 (hormone receptor-negative)
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 Recruiting
Rochester, Minnesota, United States, 55905
Contact: Mayo Clinic Clinical Trials Office     507-538-7623        
Principal Investigator: Nicole P. Sandhu, M.D.            
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Principal Investigator: Nicole P. Sandhu, M.D., Ph.D. 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

Responsible Party: Nicole P. Sandhu, M.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00719966     History of Changes
Other Study ID Numbers: CDR0000595404, P30CA015083, MC0834, 06-004006
Study First Received: July 19, 2008
Last Updated: April 20, 2012
Health Authority: United States: Federal Government

Keywords provided by Mayo Clinic:
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Exemestane
Letrozole
Anastrozole
 Aromatase Inhibitors
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on June 17, 2013