CompletedPhase 1

Safety Study of Multiple-Vaccine to Treat Metastatic Breast Cancer

Japan10 participantsStarted 2009-12

Plain-language summary

The purpose of this study is to evaluate the safety of HLA-A\*2402 restricted epitope peptides CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1 emulsified with Montanide ISA 51.

Who can participate

Age range

20 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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\<WBC\<15000/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 * Decision of unsuitableness by principal investigator or physician-in-charge

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

safety (Phase I: toxicities as assessed by NCI CTCAE version3)

Timeframe: 1 month

Trial details

NCT IDNCT01259505

SponsorTokyo Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-06

View on ClinicalTrials.gov More Metastatic Breast Cancer trials

Who can participate

Age range

20 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.