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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00973037
Recruitment Status : Unknown
Verified September 2009 by Korea University Anam Hospital.
Recruitment status was:  Recruiting
First Posted : September 9, 2009
Last Update Posted : September 9, 2009
National Cancer Center, Korea
Korean Breast Cancer Study Group
Information provided by:
Korea University Anam Hospital

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).

Condition or disease Intervention/treatment
Breast Neoplasms Tamoxifen Genotype CYP2D6 Drug: Tamoxifen

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Study Type : Observational
Estimated Enrollment : 922 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Impact of CYP2D6 Genotype on the Clinical Effects of Tamoxifen Using With Samples From Prospective Randomized Multicenter Study
Study Start Date : March 2009
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Disease-free survival(DFS) [ Time Frame: 5years ]

Biospecimen Retention:   Samples With DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
young women(≤45 years) with hormone-sensitive breast cancer who remain in premenopause or regain menstruation after chemotherapy

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00973037

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Contact: Eun Sook Lee, MD, PhD 82-2-920-6744

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Korea, Republic of
Korea University Anam Hopital Recruiting
Seoul, Korea, Republic of, 136-705
Contact: Eun Sook Lee, MD, PhD    82-2-920-6744   
Principal Investigator: Eun Sook Lee, MD, PhD         
Sponsors and Collaborators
Korea University Anam Hospital
National Cancer Center, Korea
Korean Breast Cancer Study Group
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Principal Investigator: Eun Sook Lee, MD, PhD Korea University Anam Hospital
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Responsible Party: Eun Sook, Lee, Korea University Anam Hospital Identifier: NCT00973037    
Other Study ID Numbers: AN09020
First Posted: September 9, 2009    Key Record Dates
Last Update Posted: September 9, 2009
Last Verified: September 2009
Keywords provided by Korea University Anam Hospital:
Breast neoplasms
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents