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:
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

March 2, 2010
November 15, 2012
March 2010
April 2013   (final data collection date for primary outcome measure)
Body Composition [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01080170 on ClinicalTrials.gov Archive Site
Lipids [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
The Effect of Aromatase Inhibitors on Cardiovascular Risk Factors in Women With Breast Cancer
Not Provided

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

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Breast Cancer
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
39
December 2014
April 2013   (final data collection date for primary outcome measure)

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)
Female
60 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01080170
PRO09060055, KL2RR024154-04
No
Van Londen, Gijsberta, University of Pittsburgh
University of Pittsburgh
National Center for Research Resources (NCRR)
Not Provided
University of Pittsburgh
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP