The Effect of Aromatase Inhibitors on Cardiovascular Risk Factors in Women With Breast Cancer | NCT01080170 | Trialant
CompletedObservationalUpdated May 13, 2016
The Effect of Aromatase Inhibitors on Cardiovascular Risk Factors in Women With Breast Cancer
ClinicalTrials.gov ID
NCT01080170
Lead Sponsor
University of PittsburghOTHER
Overall Status
Completed
Study Type
Observational
Enrollment
20Actual
Last Update Posted
May 13, 2016Estimated
Start Date
Mar 2010
Primary Completion Date
Jun 2013Actual
Completion Date
Jun 2013Actual
Brief Summary
This study explores how aromatase inhibitor therapy affects risk factors for heart disease in postmenopausal women with breast cancer.
Breast Cancer
No interventions
There are no interventions for this study.
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
Female
Accepts Healthy Volunteers
Yes
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)