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OpenTrials
Completed

NCT Number: NCT01080170

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

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

Completed

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Key information

Age range

60 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Pittsburgh, Department of Medicine.

Pittsburgh, Pennsylvania, 15232, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Body Composition

    Time frame: 12 months

Secondary outcomes

  1. Lipids

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Center for Research Resources (NCRR)

Registry information

Acronym: Silhouette

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Mar 3, 2010
Registry last updated
May 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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