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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

National Center for Research Resources (NCRR)

Information provided by (Responsible Party):

Van Londen, Gijsberta, University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT01080170

First received: March 2, 2010

Last updated: November 15, 2012

Last verified: November 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 2, 2010
Last Updated Date	November 15, 2012
Start Date ^ICMJE	March 2010
Estimated Primary Completion Date	April 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 2, 2010)	Body Composition [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01080170 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 2, 2010)	Lipids [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Effect of Aromatase Inhibitors on Cardiovascular Risk Factors in Women With Breast Cancer
Official Title ^ICMJE	Not Provided
Brief Summary	This study explores how aromatase inhibitor therapy affects risk factors for heart disease in postmenopausal women with breast cancer.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
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.
Condition ^ICMJE	Breast Cancer
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	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 - 1 Newly diagnosed, non-metastatic, hormone-receptor negative breast cancer patients who have undergone lumpectomy, have been advised to not require chemotherapy, but will need to undergo radiation therapy. Control group - 2 Healthy controls.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	39
Estimated Completion Date	December 2014
Estimated Primary Completion Date	April 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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)
Gender	Female
Ages	60 Years to 75 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01080170
Other Study ID Numbers ^ICMJE	PRO09060055, KL2RR024154-04
Has Data Monitoring Committee	No
Responsible Party	Van Londen, Gijsberta, University of Pittsburgh
Study Sponsor ^ICMJE	University of Pittsburgh
Collaborators ^ICMJE	National Center for Research Resources (NCRR)
Investigators ^ICMJE	Not Provided
Information Provided By	University of Pittsburgh
Verification Date	November 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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