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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)
Information provided by:
National Cancer Center, Korea Identifier:
First received: September 19, 2007
Last updated: February 9, 2010
Last verified: September 2007
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
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 ]

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
observation for clinical efficacy on tamoxifen according to CYP2D6 genotype
Drug: Tamoxifen
tamoxifen 20mg, PO, QD until disease progression


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00532454

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
Principal Investigator: Jungsil Ro, MD, PhD National Cancer Center, Korea
  More Information

Responsible Party: CENTER FOR BREAST CANCER, NATIONAL CANCER CENTER Identifier: NCT00532454     History of Changes
Other Study ID Numbers: NCCCTS-06-198
Study First Received: September 19, 2007
Last Updated: February 9, 2010

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents processed this record on June 22, 2017