UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053351 |
|---|---|
| Receipt number | R000060396 |
| Scientific Title | EC and Pembrolizumb combination therapy with Pegfilgrastim as primary prevention |
| Date of disclosure of the study information | 2024/01/16 |
| Last modified on | 2024/01/15 11:45:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
EC and Pembrolizumb combination therapy with Pegfilgrastim as primary prevention
Acronym
EC and Pembrolizumb combination therapy with Pegfilgrastim as primary prevention
Scientific Title
EC and Pembrolizumb combination therapy with Pegfilgrastim as primary prevention
Scientific Title:Acronym
ECOLOGY
Region
| Japan |
Condition
Condition
triple negative breast cancer being treated by preoperative chemotherapy
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify safety and efficacy of peg-filgrastim as a primary prevention against FN with EC plus plus pembrolizumab therapy for patients with triple negative breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
prevalence of fevrile events, FN (true-FN, surrogate-FN), antibiotics usage, number of unplanned visits, irAE (including ILD), arthralgia, usage of pain medication, PPI usage, all adverse events Grade 2-4 (CTCAE ver.5), RDI, pCR, and laboratory data
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All the patients those who receive KN522 regimen for the treatment of stage II - III TNBC
Key exclusion criteria
Those who not gave written informed consent
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Mitsunori |
| Middle name | |
| Last name | Morita |
Organization
Hyogo Cancer Center
Division name
Division of Medical Oncology
Zip code
673-8558
Address
13-70,Kitaoji-cho, Akashi, Hyogo, Japan
TEL
+81-78-929-1151
m-morita@hyogo-cc.jp
Public contact
Name of contact person
| 1st name | Mitsunori |
| Middle name | |
| Last name | Morita |
Organization
Hyogo Cancer Center
Division name
Division of Medical Oncology
Zip code
673-8558
Address
13-70, Kitaoji-cho, Akashi, Hyogo, Japan
TEL
+81-78-929-1151
Homepage URL
m-morita@hyogo-cc.jp
Sponsor or person
Institute
Hyogo Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Hyogo Cancer Center
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo Cancer Center
Address
13-70, Kitaoji-cho, Akashi, Hyogo, Japan
Tel
+81-78-929-1151
hcc-irb@hyogo-cc.jp
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
| 2024 | Year | 01 | Month | 16 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 29 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
to observe prevalence of febrile events, FN (true-FN, surrogate-FN), antibiotics usage, number of unplanned visits, irAE (including ILD), arthralgia, usage of pain medication, PPI usage, all adverse events Grade 2-4 (CTCAE ver.5), RDI, pCR, and laboratory data
Management information
Registered date
| 2024 | Year | 01 | Month | 15 | Day |
Last modified on
| 2024 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060396
