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A prospective study on prediction of sensitivity to trastuzumab using gene expression of peripheral blood mononuclear cells

A prospective study on prediction of sensitivity to trastuzumab using gene expression of peripheral blood mononuclear cells - A prospective study on prediction of sensitivity to trastuzumab using gene expression of peripheral blood mononuclear cells

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002660
Enrollment
60
Registered
2009-10-22
Start date
2009-04-01
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

bresat cancer

Interventions

single-agent trastuzumab

Sponsors

Chikako Shimizu, Kenji Tamura
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. histologically confirmed HER2-positive breast cancer patients 2. Stage IV or recurrent breast cancer 3. hormone-receptor negative or hormone-refractory 4. non life-threatning disease 5. at least one measurable lesion 6. ejection fraction no less than 55% 7. written consent by the patient

Exclusion criteria

Exclusion criteria: 1. uncontrolled CNS metastasis 2. co-existence of heart failure or past history of decline in cardiac function during trastuzumab treatment 3. pregnant women

Design outcomes

Primary

MeasureTime frame
response rate after enrichment by gene signature

Countries

Japan

Outcome results

None listed

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