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Clinical pharmacology study of anti-estrogen based on pharmacogenomics and pharmacokinetics for hormone-sensitive breast cancer patients (JBCRG-15)

Clinical pharmacology study of anti-estrogen based on pharmacogenomics and pharmacokinetics for hormone-sensitive breast cancer patients (JBCRG-15) - JBCRG-15 (PGx-PK based clinical pharmacology study of anti-estrogen)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002632
Enrollment
30
Registered
2009-11-01
Start date
2010-10-07
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Interventions

Toremifen 40mg PO Dose escaration to 120mg

Sponsors

JBCRG(Japan Breast Cancer Research Group)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Histologycally proven breast cancer On tamoxifen Reduced tamoxifen activity Able to take toremifen at least 3 months ECOG PS 0~2 20 to 70years old Adequite organ function Written IC obtained

Exclusion criteria

Exclusion criteria: History of thromboembolism Clinically significant myoma uteri Requiring CYP3A4 inhibitor Clinically significant co-morbidity Pregnant or its posibility

Design outcomes

Primary

MeasureTime frame
Change in toremifen metabolite concentration between 40mg and 120mg

Countries

Japan

Contacts

Public ContactHiroshi Ishiguro

Kyoto University Hospital Outpatient Oncology Unit

hishimd@kuhp.kyoto-u.ac.jp075-751-4771

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026