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60 Years
75 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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

- 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)

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Body Composition

Outcome Time Frame:

12 months

Safety Issue:



United States: Institutional Review Board

Study ID:




Start Date:

March 2010

Completion Date:

December 2014

Related Keywords:

  • Breast Cancer
  • Aromatase Inhibitor
  • Anastrazole
  • Arimidex
  • Heart disease
  • Lipids
  • Body composition
  • Breast cancer.
  • Breast Neoplasms



University of Pittsburgh, Department of Medicine. Pittsburgh, Pennsylvania  15232