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Evaluation of the Association Between CYP2D6 Genetic Polymorphisms and the Treatment Effect of Tamoxifen
This study is currently recruiting participants.
Verified by National Cancer Center, Korea, September 2007
Sponsored by: National Cancer Center, Korea
Information provided by: National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT00532454
  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
Drug: Tamoxifen
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Tamoxifen Tamoxifen citrate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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

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

Estimated Enrollment: 32
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00532454

Contacts
Contact: Jungsil Ro, MD, PhD 82-31-920-1610 jungsro@ncc.re.kr

Locations
Korea, Republic of, Gyeonggi-do
National Cancer Center Recruiting
809 Madu1-dong, Ilsandong-gu, 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

Study ID Numbers: NCCCTS-06-198
Study First Received: September 19, 2007
Last Updated: September 19, 2007
ClinicalTrials.gov Identifier: NCT00532454  
Health Authority: Republic of Korea: Institutional Review Board

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms
Tamoxifen
Breast Diseases

Additional relevant MeSH terms:
Estrogen Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents
Selective Estrogen Receptor Modulators
Pharmacologic Actions
Estrogen Receptor Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009