The Effect of Aromatase Inhibitors on Cardiovascular Risk Factors in Women With Breast Cancer
Status: | Recruiting |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 11/11/2012 |
Start Date: | March 2010 |
Contact: | J van Londen, MD, MS |
Phone: | 412-692-2382 |
This study explores how aromatase inhibitor therapy affects risk factors for heart disease
in postmenopausal women with breast cancer.
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)
We found this trial at
1
site
Pittsburgh, Pennsylvania 15213
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