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

NCT00532454 | Terminated Phase 2

• 1 other identifier: NCCCTS-06-198
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Breast Cancer; Metastatic Disease

Outcome Measures

Primary Outcomes (1)

• efficacy of tamoxifen

  one year

Study Arms (1)

tamoxifen

OTHER

observation for clinical efficacy on tamoxifen according to CYP2D6 genotype

Drug: Tamoxifen

Interventions

Tamoxifen DRUG

tamoxifen 20mg, PO, QD until disease progression

tamoxifen

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (2)

National Cancer Center

809 Madu1-dong, Ilsandong-gu, Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

National cancer center

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Tamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Jungsil Ro, MD, PhD

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 19, 2007
• First Posted: September 20, 2007
• Study Start: June 1, 2006
• Primary Completion: June 1, 2006
• Study Completion: December 1, 2007
• Last Updated: February 10, 2010

Record last verified: 2007-09

Locations

KR (2)