CYP2D6 Genotype on the Clinical Effect of Tamoxifen

NCT ID: NCT00973037

Last Updated: 2009-09-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 922 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2016-04-30

Brief Summary

The purpose of this study is to investigate the impact of CYP2D6 Genotype on the clinical effects of tamoxifen using with samples from prospective randomized multicenter study(ASTRRA).

Conditions

Breast Neoplasms; Tamoxifen; Genotype; CYP2D6

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

CYP2D6

CYP2D6 genotype

Tamoxifen

Intervention Type: DRUG

Tamoxifen 20mg qd

Interventions

Tamoxifen

Tamoxifen 20mg qd

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• The patient must sign the informed consent form.
• The patient must sign the informed consent of genotype screening test.
• The patient must be between 18 years old and 45 years old who can make a decision independently.
• Patients must have undergone excision of the primary breast mass, proven histologically to be invasive breast adenocarcinoma.(The type of mastectomy performed, number of axillary nodes removed, number of axillary nodes found positive, and tumor size must be included on the CRFs. For patients who have more than one discrete tumor masses should be measured and reported on the CRFs.)
• Patients must be within 3 months after the last cycle of chemotherapy.
• Patients must have the history of normal menstruation prior to the start of chemotherapy.
• Stage I, II or III
• Woman, less than or equal to 45 years of age
• The test result of the estrogen receptor is positive.
• WHO performance status 0, 1 or 2.
• Patients who were treated with cytotoxic chemotherapy in pre or post surgery. Permissible prior chemotherapy; currently locally available and approved standard chemotherapy in the adjuvant or neoadjuvant setting: e.g., AC(Doxorubicin/cyclophosphamide) followed by taxane, AC(Doxorubicin/cyclophosphamide), TA(Docetaxel/ Doxorubicin), FAC(5-fluorouracil/ doxorubicin / cyclophosphamide) or others.
• Adequate hematological function defined by hemoglobin 10g/dl, neutrophil count 1.5 X 10 9/L and platelets 100 X 10 9/L.
• Adequate hepatic function defined by AST and ALT 2.5 X upper limit of normal. Alkaline phosphatase 5 X upper limit of normal, unless bone metastases in the absence of liver disease. Renal function adequate defined by creatinine < 175 mmol/L.

Exclusion Criteria

• The test result of the estrogen receptor is negative or unknown.
• Patients with the history of hysterectomy or oophorectomy.
• Sarcomas or squamous cell carcinomas of the breast are not eligible.
• Patients with malignancies(other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell/squamous cell carcinoma of the skin.
• Investigational drugs given within the previous 4 weeks.
• Patients with thrombocytopenia (platelets < 100 X 10 9/L or on anti-coagulant therapy(contra-indicated due to risk of bleeding with i.m. injection of Zoladex).
• Patients treated with CMF(cyclophosphamide/methotrexate/5-fluorouracil) as prior chemotherapy.
• Patients who are pregnant or lactating are ineligible.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Center, Korea

OTHER_GOV

Sponsor Role: collaborator

Korean Breast Cancer Study Group

OTHER

Sponsor Role: collaborator

Korea University Anam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Korea University Anam Hospital

Principal Investigators

Eun Sook Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Korea University Anam Hospital

Locations

Korea University Anam Hopital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Eun Sook Lee, MD, PhD

Role: CONTACT

eslee@korea.ac.kr

82-2-920-6744

Facility Contacts

Eun Sook Lee, MD, PhD

Role: primary

eslee@korea.ac.kr

82-2-920-6744

Other Identifiers

AN09020

Identifier Type: -

Identifier Source: org_study_id