Clinical Trials

JBCRG-12

Effect of the genetic polymorphism of drug-metabolizing enzymes on blood concentrations of the drug in endocrine therapy for breast cancer

Status
Study Closed

Objectives
To identify CYP2D6 genetic polymorphism as a potential predictive factor in patients with hormone receptive positive breast cancer, for whom endocrine therapy with tamoxifen or toremifene was indicated, in order to determine blood concentrations of active metabolites. Relationships with adverse events and clinical effects were also examined.

Subjects

Endpoints
Primary Endpoint: Relationship between CYP2D6 genetic polymorphism and blood concentrations of anti-estrogen active metabolites, Secondary endpoints : Relationship between adverse events (hot flush) and blood concentrations of anti-estrogen active metabolites

Trial Period
2 years entry, follow up (up to the end of last drug concentration blood collection case)

Lead Principal Investigator
Hiroshi Ishiguro(Outpatient Oncology Unit, Kyoto University Hospital)

Target Sample Size
tamoxifen(100) and toremifen(100)

Regimen
tamoxifen or toremifen

Source of Funding
JBCRG

Conference Presentation
Pharmacogenomics-pharmacokinetics study of selective estrogen-receptor modulators with intra-patient dose-escalation for Japanese breast cancer patients (JBCRG-12,15)

Articles and Publications
Pharmacogenomic-pharmacokinetic study of selective estrogen-receptor modulators with intra-patient dose escalation in breast cancer (JBCRG-12/15)

UMIN-ID
UMIN000001665

jRCT

Memo

COI Disclosure

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