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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
  Purpose

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


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

Drug Information available for: Anastrozole
U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Body Composition [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Lipids [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 39
Study Start Date: March 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   60 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01080170

Locations
United States, Pennsylvania
University of Pittsburgh, Department of Medicine.
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
University of Pittsburgh
National Center for Research Resources (NCRR)
  More Information

No publications provided

Responsible Party: Van Londen, Gijsberta, PI, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01080170     History of Changes
Other Study ID Numbers: PRO09060055, KL2RR024154-04
Study First Received: March 2, 2010
Last Updated: November 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Aromatase Inhibitor
Anastrazole
Arimidex
Heart disease
 Lipids
Body composition
Breast cancer.

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anastrozole
Aromatase Inhibitors
 Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013