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

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. Identifier: NCT00131612
Recruitment Status : Terminated (did not apply for ethics renewal)
First Posted : August 19, 2005
Last Update Posted : February 26, 2016
Information provided by (Responsible Party):
AHS Cancer Control Alberta

Brief Summary:
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 or disease Intervention/treatment
Breast Cancer Drug: FEC 100

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 120 participants
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
Study Start Date : January 2002
Actual Primary Completion Date : December 2005
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: FEC 100
    5-fluoruracil, epirubicin and cyclophosphamide every three weeks for six treatments

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Receiving adjuvant or neoadjuvant FEC100

Exclusion Criteria:

  • Elevated bilirubin
  • Abnormal liver or kidney function

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 identifier (NCT number): NCT00131612

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

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

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

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