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

NCT01080170 | Completed

• 2 other identifiers: PRO09060055KL2RR024154-04
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

Aromatase Inhibitor; Anastrazole; Arimidex; Heart disease; Lipids; Body composition; Breast cancer.

Outcome Measures

Primary Outcomes (1)

• Body Composition

  12 months

Secondary Outcomes (1)

• Lipids

  12 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

University of Pittsburgh, Department of Medicine.

Pittsburgh, Pennsylvania, 15232, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Frozen serum samples. No further testing planned at the moment.

MeSH Terms

Conditions

Breast Neoplasms; Heart Diseases

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: March 2, 2010
• First Posted: March 3, 2010
• Study Start: March 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: May 13, 2016

Record last verified: 2016-05

Locations

US (1)