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

Effect of Aromatase Inhibitor Therapy for Breast Cancer on Endothelial Function

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: anastrozole; Drug: exemestane; Drug: letrozole; Procedure: assessment of therapy complications

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.

• Study Type: Observational
• Enrollment (Actual): 109

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with recently diagnosed breast cancer

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Endothelial dysfunction as a result of aromatase inhibitor therapy

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Nicole P. Sandhu, M.D., Ph.D., Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2008
• Primary Completion (Actual): June 13, 2013
• Study Completion (Actual): January 24, 2020

Study Registration Dates

• First Submitted: July 19, 2008
• First Submitted That Met QC Criteria: July 19, 2008
• First Posted (Estimated): July 22, 2008

Study Record Updates

• Last Update Posted (Estimated): January 1, 2024
• Last Update Submitted That Met QC Criteria: December 28, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: stage IV breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage II breast cancer; stage IIIC breast cancer; stage IA breast cancer; stage IB breast cancer; ductal breast carcinoma in situ
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Letrozole; Anastrozole; Exemestane
• Other Study ID Numbers: MC0834; 06-004006 (Other Identifier: Mayo Clinic IRB)