CYP2D6 Genotype on the Clinical Effect of Tamoxifen (ASTRRA-CYP2D6)

Impact of CYP2D6 Genotype on the Clinical Effects of Tamoxifen Using With Samples From Prospective Randomized Multicenter Study

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).

Study Overview

• Status: Unknown
• Conditions: Breast Neoplasms; Genotype; Tamoxifen; CYP2D6
• Intervention / Treatment: Drug: Tamoxifen

• Study Type: Observational
• Enrollment (Anticipated): 922

Contacts and Locations

• Study Contact: Name: Eun Sook Lee, MD, PhD; Phone Number: 82-2-920-6744; Email: eslee@korea.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 136-705
    • Recruiting
    • Korea University Anam Hopital
    • Contact: Eun Sook Lee, MD, PhD; Phone Number: 82-2-920-6744; Email: eslee@korea.ac.kr
    • Principal Investigator: Eun Sook Lee, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

young women(≤45 years) with hormone-sensitive breast cancer who remain in premenopause or regain menstruation after chemotherapy

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CYP2D6; CYP2D6 genotype	Drug: Tamoxifen; Tamoxifen 20mg qd

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Disease-free survival(DFS)	5years

Collaborators and Investigators

• Sponsor: Korea University Anam Hospital
• Collaborators: National Cancer Center, Korea; Korean Breast Cancer Study Group
• Investigators: Principal Investigator: Eun Sook Lee, MD, PhD, Korea University Anam Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Anticipated): April 1, 2016
• Study Completion (Anticipated): April 1, 2016

Study Registration Dates

• First Submitted: September 8, 2009
• First Submitted That Met QC Criteria: September 8, 2009
• First Posted (Estimate): September 9, 2009

Study Record Updates

• Last Update Posted (Estimate): September 9, 2009
• Last Update Submitted That Met QC Criteria: September 8, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Tamoxifen; Genotype; CYP2D6; Breast neoplasms
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Bone Density Conservation Agents; Estrogen Antagonists; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Tamoxifen
• Other Study ID Numbers: AN09020