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

• ClinicalTrials.gov Identifier: NCT00719966
• Recruitment Status: Active, not recruiting
• First Posted: July 22, 2008
• Last Update Posted: October 5, 2018
• Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Mayo Clinic

Study Description

Brief Summary:

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 or disease	Intervention/treatment
Breast Cancer	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 Design

• Study Type: Observational
• Estimated Enrollment: 109 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Effect of Aromatase Inhibitor Therapy for Breast Cancer on Endothelial Function
• Actual Study Start Date: June 2008
• Actual Primary Completion Date: June 13, 2013
• Estimated Study Completion Date: September 2020

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. Endothelial dysfunction as a result of aromatase inhibitor therapy

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 80 Years (Adult, Older Adult)
• Sexes 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

Locations

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Nicole P. Sandhu, M.D., Ph.D.; Mayo Clinic

More Information

• Responsible Party: Mayo Clinic
• ClinicalTrials.gov Identifier: NCT00719966 History of Changes
• Other Study ID Numbers: MC0834; P30CA015083 ( U.S. NIH Grant/Contract ); MC0834 ( Other Identifier: Mayo Clinic Cancer Center ); 06-004006 ( Other Identifier: Mayo Clinic IRB )
• First Posted: July 22, 2008
• Last Update Posted: October 5, 2018
• Last Verified: October 2018

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:

Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Letrozole; Anastrozole; Exemestane; Aromatase Inhibitors; Physiological Effects of Drugs; Antineoplastic Agents; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Estrogen Antagonists; Antineoplastic Agents, Hormonal