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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00719966
First received: July 19, 2008
Last updated: March 24, 2014
Last verified: March 2014
  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: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Aromatase Inhibitor Therapy for Breast Cancer on Endothelial Function

Resource links provided by NLM:


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: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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
Sampling Method:   Non-Probability Sample
Study Population

Patients with recently diagnosed breast cancer

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Nicole P. Sandhu, M.D., Ph.D. Mayo Clinic
  More Information

Additional Information:
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: MC0834, P30CA015083, MC0834, 06-004006
Study First Received: July 19, 2008
Last Updated: March 24, 2014
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 August 01, 2014