The Effect of Aromatase Inhibitors on Cardiovascular Risk Factors in Women With Breast Cancer

NCT ID: NCT01080170

Last Updated: 2016-05-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2013-06-30

Brief Summary

This study explores how aromatase inhibitor therapy affects risk factors for heart disease in postmenopausal women with breast cancer.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Anastrazole

Newly diagnosed, non-metastatic, hormone-receptor positive breast cancer patients, who have undergone lumpectomy, have been advised to not require chemotherapy, but will need to undergo radiation therapy and will be initiating therapy with anastrazole.

No interventions assigned to this group

Control group - 2

Healthy controls.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Ambulatory women (aged 60-75), with a new diagnosis of nonmetastatic, hormone-receptor positive breast cancer, having undergone lumpectomy. They will not need chemotherapy and will have been prescribed but not yet started anastrazole. All will need a course of radiation therapy as part of usual care. Participants are instructed not to change their physical activity or eating habits over the period of the study.

Comparisons are:

• Identical to the cases except they are hormone-receptor negative and don't need hormonal therapy.
• Healthy controls.

Exclusion Criteria

• Nicotine usage
• Metastatic breast cancer
• Need for chemotherapy
• AI other than anastrazole
• Usage of steroids (equivalent of equal then or more than 7.5 mg prednisone x 3 months)
• Clinically significant abnormality of thyroid function
• Treatment with gonadal hormone replacement therapy within last 3 years
• Status post unilateral/bilateral surgical oophorectomy
• Having experienced a medical event, which may confound study outcomes [e.g. heart attack, stroke, cancer (metastatic or newly diagnosed within last 5 years, except for non-melanoma skin cancer and breast), lupus, rheumatoid arthritis, chronic inflammatory disease]
• Medication-dependent diabetes mellitus or hypercholesterolemia.
• Gastric surgery
• Weight loss medication (prescription or over the counter)

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Research Resources (NCRR)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Van Londen, Gijsberta

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Pittsburgh, Department of Medicine.

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

KL2RR024154-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRO09060055

Identifier Type: -

Identifier Source: org_study_id