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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01080170

Acronym

Silhouette

Enrollment

Registered

2010-03-03

Start date

2010-03-31

Completion date

2013-06-30

Last updated

2016-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Aromatase Inhibitor, Anastrazole, Arimidex, Heart disease, Lipids, Body composition, Breast cancer.

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

60 Years to 75 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
Body Composition	12 months

Secondary

Measure	Time frame
Lipids	12 months

Countries

United States

Outcome results