24 Months of Exemestane or Letrozole to Treat Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Pfizer
Novartis
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00263913
First received: December 7, 2005
Last updated: December 9, 2013
Last verified: December 2013
  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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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:
    Drug: Exemestane and letrozole
    The drug you will take will be exemestane 25 mg by mouth daily or letrozole 2.5 mg by mouth daily.
    Drug: Letrozole
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan Cancer Center
Pfizer
Novartis
Investigators
Principal Investigator: Daniel Hayes, M.D. University of Michigan
  More Information

No publications provided

Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00263913     History of Changes
Other Study ID Numbers: UMCC 2005.074, HUM 379
Study First Received: December 7, 2005
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan Cancer Center:
breast cancer best treated with aromatase inhibitors.

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Exemestane
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014