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A Multi-Center Randomized Clinical Trial Correlating the Effects of 24 Months of Exemestane or Letrozole on Surrogate Markers of Response With Aromatase Polymorphism


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

A Multi-Center Randomized Clinical Trial Correlating the Effects of 24 Months of Exemestane or Letrozole on Surrogate Markers of Response With Aromatase Polymorphism


Inclusion Criteria:



- Females with at least Stage I-III breast cancer that has not metastasized and it has
been determined it can best be treated with an aromatase inhibitor

- 18 years of age or older

- Post-menopausal

Exclusion Criteria:

- Both breasts have been surgically removed

- Have previously had radiation therapy to the unaffected breast

- Have previously taken an aromatase inhibitor

- Have a history of cancer of ovarian, endometrial, fallopian tube, and primary
peritoneal carcinomatosis

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Identify which women are more likely to have certain benefits or side effects from one or the other of exemestane and letrozole. The researchers will be looking at their genes and at the medication's effects on their body.

Outcome Time Frame:

refer to protocol

Safety Issue:

No

Principal Investigator

Daniel Hayes, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan

Authority:

United States: Institutional Review Board

Study ID:

UMCC 2005.074

NCT ID:

NCT00263913

Start Date:

November 2005

Completion Date:

November 2015

Related Keywords:

  • Breast Cancer
  • breast cancer best treated with aromatase inhibitors.
  • Breast Neoplasms

Name

Location

University of MichiganAnn Arbor, Michigan  48109-0624