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

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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)
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