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Phase I/II Study of Multiple-Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*2402 in Treating Patients With Refractory Breast Cancer

Phase 1/Phase 2
20 Years
85 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Phase I/II Study of Multiple-Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*2402 in Treating Patients With Refractory Breast Cancer

TTK has been identified as cancer specific molecules especially in breast cancer using
genome-wide expression profile analysis by cDNA microarray technique. We have determined the
HLA-A*2402 restricted epitope peptide derived from this molecule and identified that this
peptide significantly induces the effective tumor specific CTL response in vitro and vivo.
According to these findings, in this trial, we evaluate the safety, immunological and
clinical response of that peptide. Patients will be vaccinated twice a week for 8 weeks. On
each vaccination day, TTK-A24-567 peptide (1mg) mixed with Montanide ISA 51 will be
administered by subcutaneous injection. Repeated cycles of vaccine will be administered
until patients develop progressive disease or unacceptable toxicity, whichever occurs first.
In the phase I study, we evaluate the safety and tolerability of this peptide vaccine. In
the following phase II study, we evaluate the immunological and clinical response of this
vaccine therapy.

Inclusion Criteria:

- Advanced or recurrent breast cancer

- Resistant against anthracycline-based and taxane-based chemotherapy or difficult to
continue the chemotherapy due to intolerable side effect(s)

- Resistant against trastuzumab or difficult to continue it due to intolerable side
effect(s) when her-2 is positive

- ECOG performance status 0-2

- Life expectancy > 3 months

- HLA-A*2402

- Laboratory values as follows

- 2000/mm3
- Platelet count>100000/mm3

- Bilirubin < 3.0mg/dl

- Asparate transaminase < 150IU/L

- Alanine transaminase < 150IU/L

- Creatinine < 3.0mg/dl

- Able and willing to give valid written informed consent

Exclusion Criteria:

- Pregnancy(woman of childbearing potential:Refusal or inability to use effective means
of contraception)

- Breastfeeding

- Active or uncontrolled infection

- Concurrent treatment with steroids or immunosuppressing agent

- Prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks

- Uncontrolled brain and/or intraspinal

- Decision of unsuitableness by principal investigator or physician-in-charge

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

safety (Phase I: toxicities as assessed by NCI CTCAE version3) and efficacy (Phase II: feasibility as evaluated by RECIST)

Outcome Time Frame:

2 months

Safety Issue:


Principal Investigator

Masaru Shinozaki, MD/PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Head, Department of Surgery


Japan: Institutional Review Board

Study ID:

Breast-A24-I, II



Start Date:

May 2008

Completion Date:

March 2009

Related Keywords:

  • Breast Cancer
  • HLA-A*2402
  • Peptide Vaccine
  • TTK
  • Breast Neoplasms