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

University of Pittsburgh

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01080170

PRO09060055

KL2RR024154-04 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: Female

Ages: 60 to 75 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

20 participants in 2 patient groups

Anastrazole

Description:

Newly diagnosed, non-metastatic, hormone-receptor positive breast cancer patients, who have undergone lumpectomy, have been advised to not require chemotherapy, but will need to undergo radiation therapy and will be initiating therapy with anastrazole.

Control group - 2

Description:

Healthy controls.