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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014616
Receipt No. R000016969
Scientific Title 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.
Date of disclosure of the study information 2014/08/01
Last modified on 2019/01/08

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Basic information
Public title 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.
Acronym PhaseII study of peptide vaccines (KRM-19) for metastatic recurrent triple negative breast cancer
Scientific Title 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.
Scientific Title:Acronym PhaseII study of peptide vaccines (KRM-19) for metastatic recurrent triple negative breast cancer
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 A phase II study using 19 personalized peptide vaccines for metastatic recurrent breast cancer patients who had been resistant to standard treatment. The safety and tumor specific immune response will be investigated.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Safety
Key secondary outcomes Progression free survival time
Tumor specific immune response

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Vaccine
Interventions/Control_1 10/0
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key 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
Key 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.
Target sample size 10

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Toh Uhi
Organization Kurume University School
of Medicine
Division name Department of Surgery
Zip code
Address 67 Asahi-machi,Kurume city,Fukuoka
TEL 0942-35-3311
Email utoh@med.kurume-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Toh Uhi
Organization Kurume University School of Medicine
Division name Department of Surgery
Zip code
Address 67 Asahi-machi,Kurume city,Fukuoka
TEL 0942-35-3311
Homepage URL
Email utoh@med.kurume-u.ac.jp

Sponsor
Institute Kurume University School
of Medicine
Department of Surgery
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2014 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 06 Month 11 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 01 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 09 Month 01 Day
Date trial data considered complete
2018 Year 12 Month 01 Day
Date analysis concluded
2018 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 07 Month 23 Day
Last modified on
2019 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016969

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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