UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014616 |
|---|---|
| Receipt number | 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 18:33:05 |
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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
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
utoh@med.kurume-u.ac.jp
Public contact
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
utoh@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University School
of Medicine
Department of Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016969
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
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