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

September 8, 2009 updated by: Korea University Anam Hospital

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

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

922

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 136-705
        • Recruiting
        • Korea University Anam Hopital
        • Contact:
        • Principal Investigator:
          • Eun Sook Lee, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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)
Time Frame: 5years
5years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AN09020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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