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An Investigation of the Effect of the Promoter Polymorphism in the Glucuronosyltransferase 2B7 in Patients on Breast Cancer Treatment

This study has been terminated.
(did not apply for ethics renewal)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00131612
First Posted: August 19, 2005
Last Update Posted: February 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AHS Cancer Control Alberta
  Purpose
For many years scientists and cancer researchers have been trying to find out why some people benefit more from anti-cancer medications than other people who receive the same amount and same kind of medications. Current studies suggest that inherited characteristics might explain these differences. Height and eye color are examples of characteristics that have been inherited from parents. Studies suggest that people might also inherit genetic differences in how their bodies break down medications. When a person receives an anti-cancer medication, it is broken down by the liver into smaller parts or by-products. To try to understand more about how people's bodies break down anti-cancer medications, the researchers are studying the by-products (called metabolites) of epirubicin in the blood of people who are taking this medication as part of their breast cancer treatment.

Condition Intervention
Breast Cancer Drug: FEC 100

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An Investigation of the Effect of the Promoter Polymorphism in the Glucuronosyltransferase 2B7 Using Epirubicin Clearance and the Ratios of Epirubicin and Epirubicinol Glucuronide to Epirubicin

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

Enrollment: 120
Study Start Date: January 2002
Study Completion Date: January 2013
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: FEC 100
    5-fluoruracil, epirubicin and cyclophosphamide every three weeks for six treatments
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cross Cancer Clinic patients
Criteria

Inclusion Criteria:

  • Receiving adjuvant or neoadjuvant FEC100

Exclusion Criteria:

  • Elevated bilirubin
  • Abnormal liver or kidney function
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00131612


Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
Principal Investigator: Michael Sawyer, MD AHS Cancer Control Alberta
  More Information

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00131612     History of Changes
Other Study ID Numbers: BR-01-0031 / 17027
First Submitted: August 17, 2005
First Posted: August 19, 2005
Last Update Posted: February 26, 2016
Last Verified: June 2012

Keywords provided by AHS Cancer Control Alberta:
adjuvant therapy
epirubicin
uridine glucuronosyl/transferase 2B7
pharmacogenetics

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Epirubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action