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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2009 by Korea University Anam Hospital
Sponsor:
Collaborators:
National Cancer Center, Korea
Korean Breast Cancer Study Group
Information provided by:
Korea University Anam Hospital
ClinicalTrials.gov Identifier:
NCT00973037
First received: September 8, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

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 Intervention
Breast Neoplasms
Tamoxifen
Genotype
CYP2D6
Drug: Tamoxifen

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Korea University Anam Hospital:

Primary Outcome Measures:
  • Disease-free survival(DFS) [ Time Frame: 5years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum


Estimated Enrollment: 922
Study Start Date: March 2009
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
CYP2D6
CYP2D6 genotype
Drug: Tamoxifen
Tamoxifen 20mg qd

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00973037

Contacts
Contact: Eun Sook Lee, MD, PhD 82-2-920-6744 eslee@korea.ac.kr

Locations
Korea, Republic of
Korea University Anam Hopital Recruiting
Seoul, Korea, Republic of, 136-705
Contact: Eun Sook Lee, MD, PhD    82-2-920-6744    eslee@korea.ac.kr   
Principal Investigator: Eun Sook Lee, MD, PhD         
Sponsors and Collaborators
Korea University Anam Hospital
National Cancer Center, Korea
Korean Breast Cancer Study Group
Investigators
Principal Investigator: Eun Sook Lee, MD, PhD Korea University Anam Hospital
  More Information

No publications provided

Responsible Party: Eun Sook, Lee, Korea University Anam Hospital
ClinicalTrials.gov Identifier: NCT00973037     History of Changes
Other Study ID Numbers: AN09020
Study First Received: September 8, 2009
Last Updated: September 8, 2009
Health Authority: Republic of Korea: Institutional Review Board

Keywords provided by Korea University Anam Hospital:
Breast neoplasms
Tamoxifen
Genotype
CYP2D6

Additional relevant MeSH terms:
Neoplasms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Tamoxifen
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 16, 2014