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

Breast Cancer Clinical Trial

— Silhouette  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01080170
• Other study ID #: PRO09060055
• Secondary ID: KL2RR024154-04
• Status: Completed
• Phase: N/A
• First received: March 2, 2010
• Last updated: May 11, 2016
• Start date: March 2010
• Est. completion date: June 2013

Study information

• Verified date: May 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 60 Years to 75 Years

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
United States	University of Pittsburgh, Department of Medicine.	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Composition		12 months	Yes
Secondary	Lipids		12 months	Yes