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

Completed

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

Recruitment & Eligibility

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)

Primary Outcome Measures

Name	Time	Method
Body Composition	12 months

Secondary Outcome Measures

Name	Time	Method
Lipids	12 months

Locations (1): University of Pittsburgh, Department of Medicine.
🇺🇸
Pittsburgh, Pennsylvania, United States

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