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A early phase II study using 19 personalized peptide vaccines (KRM-19) for metastatic recurrent triple negative breast cancer patients who had been resistant to standard treatment.

A early phase II study using 19 personalized peptide vaccines (KRM-19) for metastatic recurrent triple negative breast cancer patients who had been resistant to standard treatment. - PhaseII study of peptide vaccines (KRM-19) for metastatic recurrent triple negative breast cancer

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000014616
Enrollment
10
Registered
2014-08-01
Start date
2014-08-01
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

Breast cancer

Interventions

10/0

Sponsors

Kurume University School of Medicine Department of Surgery
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1)Patients who have been diagnosed as standard treatment-resistant breast cancer with or without an evaluation lesion. 2)Performance Status: 0-1 (ECOG) 3)The expected survival time longer than 3 months from the entry. 4)Sufficient function of important organs prior to entry: WBC >= 2,500/mm3 lymphocytes>= 1,000/mm3 Hb >= 8.0 g/dL Plt. >= 80,000/mm3 Serum creatinine: <=2 times of the upper limit within normal range in each institute Total bilirubin <=2 times of the upper limit within normal range in each institute 5)Age >= 20 6)Written informed consent to participate

Exclusion criteria

Exclusion criteria: 1)Serious complication including active severe infection, circulatory failure, respiratory failure, renal failure, immunodeficiency, blood coagulation disorder etc. 2)Patients with active double cancer. 3)Patients who had a history of serious allergic disease. 4)(Female) pregnant women, lactating women and patients who want to become pregnant. Male breast cancer patients. 5)Other patients who are identified inappropriate patients for this study by the physicians in charge.

Design outcomes

Primary

MeasureTime frame
Safety

Secondary

MeasureTime frame
Progression free survival time Tumor specific immune response

Countries

Japan

Contacts

Public ContactToh Uhi

Kurume University School of Medicine Department of Surgery

utoh@med.kurume-u.ac.jp0942-35-3311

Outcome results

None listed

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