We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tamoxifen Pharmacokinetics and CYP2D6 Polymorphisms in Asian Women With Hormone Receptor Positive Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00717015
First Posted: July 16, 2008
Last Update Posted: April 3, 2012
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:
National University Hospital, Singapore
  Purpose

We hypothesized that subjects with CYP2D6*10 alleles may have a lower steady state levels of endoxifen due to reduced conversion of tamoxifen to endoxifen.

Primary objectives:

  • To determine the steady state pharmacokinetics of tamoxifen and its metabolites
  • To test the effects of genetic polymorphisms of CYP2D6 on plasma concentration of tamoxifen and its metabolites in hormone receptor positive women who are taking tamoxifen as adjuvant treatment for breast cancer.

Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Tamoxifen Pharmacokinetics and CYP2D6 Polymorphisms in Asian Women With Hormone Receptor Positive Breast Cancer

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • To determine the steady state pharmacokinetics of tamoxifen and its metabolites
  • To test the effects of genetic polymorphisms of CYP2D6 on plasma concentration of tamoxifen and its metabolites in hormone receptor positive women who are taking tamoxifen as adjuvant treatment for breast cancer.

Study Start Date: November 2005
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
We aim to enroll 200 patients onto our study over a period of 2 years. Patients will be recruited from the oncology outpatient clinic in National University Hospital. Participation in the study will be strictly voluntary and written informed consent will be obtained from all subjects according to institutional and governmental guidelines. Consent will be obtained by attending doctors or co-investigators of the study prior to blood sampling.
Criteria

Inclusion Criteria:

  • Signed informed consent.
  • At least 18 years of age.
  • On tamoxifen for at least 3 months for adjuvant therapy.
  • On a stable diet for past 1 week before blood sampling.
  • Compliant with tamoxifen medication.
  • Completed adjuvant chemotherapy and/or adjuvant radiation therapy.

Exclusion Criteria:

• Patients should not be on the list of medications for the last 1 week before accrual to the study

  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): NCT00717015


Locations
Singapore
National University Hospital
Singapore, Singapore
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Principal Investigator: Chiung Ing Wong, MRCP, MB ChB National University Hospital, Singapore
  More Information

ClinicalTrials.gov Identifier: NCT00717015     History of Changes
Other Study ID Numbers: BR02/06/06
First Submitted: July 14, 2008
First Posted: July 16, 2008
Last Update Posted: April 3, 2012
Last Verified: April 2012

Keywords provided by National University Hospital, Singapore:
Hormone Receptor Positive Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Tamoxifen
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogen Antagonists
Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents