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Phase I study of Multiple-Vaccine Therapy in Patient with Refractory Breast Cancer to Chemotherapy.

Phase I study of Multiple-Vaccine Therapy in Patient with Refractory Breast Cancer to Chemotherapy. - Phase I study of Multiple-Vaccine Therapy in Patient with Refractory Breast Cancer to Chemotherapy.

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002408
Enrollment
6
Registered
2009-09-01
Start date
2009-09-01
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

Three peputides restricted to HLA-A*2402(1.0mg for each)are administered 12 times once a week.

Sponsors

Department of Breast and Endocrine Surgery, Juntendo University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Advanced breast cancer which is refractory to any chemotherapy. 2.Age between 20 to 85 3.ECOG performance status 0-2 4.WBC > 3000/mm3 Platelet > 75000/mm3 Hemoglobon > 9.0g/dL Serum creatinine <2.0mg/dL Asparate transaminase > 120 IU/L Alanine transaminase > 120 IU/L Total bilirubin < 2.5mg/dL 5.More than 4 weeks later after treatment(chemotherapy/radiotherapy etc) 6.Life expectancy > 3 manths 7.HLA-A*2402 8.Have a lesion which can be measured by CT/MRI 9.Able and willing to give valid written informed cansent

Exclusion criteria

Exclusion criteria: 1.No uncontrollable infections 2.No curative traumatic wound 3.No uncontrollable ulcera 4.No abnormal coagulation 5.Concurrent treatment with acetylsalicylic acid and/or NSAIDs 6.No thrombosis 7.No severe complications (heart failure etc) 8.No other malignancy requiring treatment 9.Concurrent treatment with steroids or immunosuppressing agent 10.No Psychosis 11.Pregnancy/Breast feeding 12.Decision of unsuitableness by principal investigator or physician in change

Design outcomes

Primary

MeasureTime frame
Evaluation of safety and adverse effect of vaccination therapy

Countries

Japan

Outcome results

None listed

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