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

This study has been completed.
Sponsor:
Information provided by:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT00717015
First received: July 14, 2008
Last updated: April 2, 2012
Last verified: April 2012
History of Changes
  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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • To determine the steady state pharmacokinetics of tamoxifen and its metabolites [ Designated as safety issue: No ]
  • 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. [ Designated as safety issue: No ]

Study Start Date: November 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00717015     History of Changes
Other Study ID Numbers: BR02/06/06
Study First Received: July 14, 2008
Last Updated: April 2, 2012
Health Authority: Singapore: Domain Specific Review Boards

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
 Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Bone Density Conservation Agents
Estrogen Antagonists

ClinicalTrials.gov processed this record on May 21, 2013