UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021514 |
|---|---|
| Receipt number | R000024808 |
| Scientific Title | PRECIOUS trial |
| Date of disclosure of the study information | 2016/03/17 |
| Last modified on | 2016/03/17 14:22:34 |
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Basic information
Public title
PRECIOUS trial
Acronym
PRECIOUS trial
Scientific Title
PRECIOUS trial
Scientific Title:Acronym
PRECIOUS trial
Region
| Japan |
Condition
Condition
advanced and recurrent breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the effecacy and safety of pertubumab for the pateints with breast cancer who has been treasted with pertuzumab before.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression-free survival
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
pertuzumab 420mg/kg iv every 3 week
trasuzumab 6mg/kg iv every 3 week
other chemotherapy(docetaxel, paclitaxel,nab-packitaxel,vinorerbin)
Interventions/Control_2
trasuzumab 6mg/kg iv every 3 week
other chemotherapy(docetaxel, paclitaxel,nab-packitaxel,vinorerbin)
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
Key exclusion criteria
2
Target sample size
370
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | ken-ichi Ito |
Organization
Shinshu unniversity, department of meddicine
Division name
Surgery(2)
Zip code
Address
matumoto city,adahi 3-1-1
TEL
0263-37-2657
kenito@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | ken-ichi Ito |
Organization
Shinshu unniversity, department of medicine
Division name
Surgery(2)
Zip code
Address
matumoto city,adahi 3-1-1
TEL
0263-37-2657
Homepage URL
kenito@shinshu-u.ac.jp
Sponsor or person
Institute
Aichi cancer center hospital
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co
Organization
Division
Category of Funding Organization
Profit organization
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
| 2016 | Year | 03 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 03 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 17 | Day |
Last modified on
| 2016 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024808
