Evaluation of the Association Between CYP2D6 Genetic Polymorphisms and the Treatment Effect of Tamoxifen

This study has been terminated.
(planned to design a prospective study)
Sponsor:
Information provided by:
National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT00532454
First received: September 19, 2007
Last updated: February 9, 2010
Last verified: September 2007
  Purpose

Primary objectives of this study is to evaluate the effects of CYP2D6 genotypes on time to progression after tamoxifen treatment in pre- or postmenopausal women with metastatic breast cancer. Furthermore, we will evaluate the effects of CYP2D6 genotypes on clinical benefit and response duration to tamoxifen administration in pre- or postmenopausal women with metastatic breast cancer and also evaluate the effects of CYP2D6 genotypes on the steady state plasma concentration of tamoxifen and its metabolites


Condition Intervention Phase
Breast Cancer
Metastatic Disease
Drug: Tamoxifen
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Study for the Evaluation of the Association Between CYP2D6 Genetic Polymorphisms and the Treatment Effect of Tamoxifen in Patients With Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • efficacy of tamoxifen [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: June 2006
Study Completion Date: December 2007
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
tamoxifen
observation for clinical efficacy on tamoxifen according to CYP2D6 genotype
Drug: Tamoxifen
tamoxifen 20mg, PO, QD until disease progression
Other Name: tamoxifen

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically diagnosed stage IV or recurrent breast cancer patients according to American Joint Committee on Cancer (AJCC)
  • Positive estrogen receptor or Positive progesterone receptor.
  • Females at least 18 years of age.
  • Prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease
  • Prior hormone therapy less than 2.
  • No history of Megace medication for recent 28 days
  • Performance status of 0, 1 and 2 on the ECOG criteria
  • Clinically measurable disease, defined as bidimensionally measurable lesions with clearly defined margins on x-ray, CT scan, MRI or physical examination. Lesions serving as measurable disease must be at east 1 cm by 1 cm, as defined by x-ray, CT scan, MRI, or physical examination
  • Bone only or pleural fluid only disease is included as long as evaluation for clinical benefit is possible
  • Estimated life expectancy of at least 12 weeks
  • Compliant patient who can be followed-up adequately.
  • Adequate hematologic (WBC count 3,000/mm3, platelet count 100,000/mm3), hepatic (bilirubin level 1.8 mg/dL, AST, ALT 1.5xULN, albumin 2.5 g/dL), and renal (creatinine concentration 1.5 mg/dL) function.
  • Informed consent from patient or patient's relative
  • Childbearing women should use non-hormonal contraceptive method

Exclusion Criteria:

  • Active or uncontrolled infection.
  • Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence).
  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: NCT00532454

Locations
Korea, Republic of
National Cancer Center
809 Madu1-dong, Ilsandong-gu, Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
National cancer center
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: Jungsil Ro, MD, PhD National Cancer Center, Korea
  More Information

No publications provided

Responsible Party: CENTER FOR BREAST CANCER, NATIONAL CANCER CENTER
ClinicalTrials.gov Identifier: NCT00532454     History of Changes
Other Study ID Numbers: NCCCTS-06-198
Study First Received: September 19, 2007
Last Updated: February 9, 2010
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Tamoxifen
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on October 01, 2014