24 Months of Exemestane or Letrozole to Treat Breast Cancer - Full Text View

Sponsors and Collaborators:	University of Michigan Cancer Center Pfizer Novartis
Information provided by:	University of Michigan Cancer Center
ClinicalTrials.gov Identifier:	NCT00263913

Purpose

This research study is looking at certain medications used to treat breast cancer called aromatase inhibitors.

This study is being done because it has been determined that an aromatase inhibitor is the best way to treat certain types of breast cancer. The effects of exemestane and letrozole, both are aromatase inhibitors with very different chemical compounds, will be studied to try to identify which women are more likely to have certain benefits or side effects from one or the other of these two medications. The researchers will be looking at the women's genes and at the medication's effects on their body.

Condition	Intervention
Breast Cancer	Drug: Exemestane and letrozole Drug: Letrozole

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Letrozole Exemestane

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment
Official Title:	A Multi-Center Randomized Clinical Trial Correlating the Effects of 24 Months of Exemestane or Letrozole on Surrogate Markers of Response With Aromatase Polymorphism

Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:

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. [ Time Frame: refer to protocol ] [ Designated as safety issue: No ]

Estimated Enrollment:	160
Study Start Date:	November 2005
Estimated Study Completion Date:	November 2015
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Intervention Details:

The drug you will take will be exemestane 25 mg by mouth daily or letrozole 2.5 mg by mouth daily.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00263913

Contacts

Contact: Cancer Answer Line

800-865-1125

Locations

United States, Michigan
University of Michigan	Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Cancer Answer Line 800-865-1125
Contact: Jill Hayden, R.N. 734 936 8349 jhayden@umich.edu
Principal Investigator: Daniel Hayes, M.D.

Sponsors and Collaborators

University of Michigan Cancer Center

Pfizer

Novartis

Investigators

Principal Investigator:

Daniel Hayes, M.D.

University of Michigan

More Information

Responsible Party:	U of M ( Cancer Answer Line )
Study ID Numbers:	UMCC 2005.074
Study First Received:	December 7, 2005
Last Updated:	July 25, 2008
ClinicalTrials.gov Identifier:	NCT00263913
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Michigan Cancer Center:

breast cancer best treated with aromatase inhibitors.

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Letrozole
Exemestane
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Aromatase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009