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

Completed

Conditions studied: Breast Cancer

In brief

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

Key facts

Study ID

NCT01080170

Run by

University of Pittsburgh

People needed

20

Starts

2010-03-01

Expected to finish

2013-06-01

Last updated by the study team

2016-05-13

Who can join

Age: 60 and older, up to 75. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• University of Pittsburgh, Department of Medicine. — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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