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

May 11, 2016 updated by: Van Londen, Gijsberta, University of Pittsburgh
This study explores how aromatase inhibitor therapy affects risk factors for heart disease in postmenopausal women with breast cancer.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh, Department of Medicine.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Breast cancer patients will be recruited via the Magee Breast Cancer Program of the Cancer Center at the University of Pittsburgh Medical Center. Healthy controls will be recruited via registries.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Anastrazole
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
Healthy controls.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body Composition
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Lipids
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

National Center for Research Resources (NCRR)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

March 2, 2010

First Submitted That Met QC Criteria

March 2, 2010

First Posted (Estimate)

March 3, 2010

Study Record Updates

Last Update Posted (Estimate)

May 13, 2016

Last Update Submitted That Met QC Criteria

May 11, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO09060055
  • KL2RR024154-04 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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