UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029590 |
|---|---|
| Receipt number | R000033806 |
| Scientific Title | An accompanying research for the Phase II study of nivolumab + bevacizumab + paclitaxel in patients with HER2-negative metastatic breast cancer:WJOG9917B(WJOG9917BTR) |
| Date of disclosure of the study information | 2017/10/17 |
| Last modified on | 2023/08/08 14:15:52 |
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Basic information
Public title
An accompanying research for the Phase II study of nivolumab + bevacizumab + paclitaxel in patients with HER2-negative metastatic breast cancer:WJOG9917B(WJOG9917BTR)
Acronym
Accompanying research for the Phase II breast cancer study WJOG9917B(WJOG9917BTR)
Scientific Title
An accompanying research for the Phase II study of nivolumab + bevacizumab + paclitaxel in patients with HER2-negative metastatic breast cancer:WJOG9917B(WJOG9917BTR)
Scientific Title:Acronym
Accompanying research for the Phase II breast cancer study WJOG9917B(WJOG9917BTR)
Region
| Japan |
Condition
Condition
HER2-negative metastatic breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to reveal the biomarker of nivolumab in combination with paclitaxel and bevacizumab for patients with HER2-negative metastatic breast cancer
Basic objectives2
Others
Basic objectives -Others
Accompanying research for the Phase II breast cancer study WJOG9917B(WJOG9917BTR)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Immune-related biomarker of nivolumab in combination with paclitaxel and bevacizumab
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patients who agreed to this study (WJOG9917BTR) among those who participated in WJOG9917B trial
Key exclusion criteria
None
Target sample size
51
Research contact person
Name of lead principal investigator
| 1st name | Yukinori |
| Middle name | |
| Last name | Ozaki |
Organization
The Cancer Institute Hospital Of JFCR
Division name
Beast Oncology Center
Zip code
135-8550
Address
3-8-31, Ariake, Koto, Tokyo 135-8550, Japan
TEL
03-3520-0111
yukinori.ozaki@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Nakamura |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
556-0016
Address
Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
Funding Source
Organization
ONO PHARMACEUTICAL CO., LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
None
Address
None
Tel
None
None
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
虎の門病院（東京都）
近畿大学医学部附属病院（大阪府）
兵庫県立がんセンター（兵庫県）
国立がん研究センター中央病院（東京都）
国立がん研究センター東病院（千葉県）
北海道がんセンター（北海道）
神戸大学医学部附属病院（兵庫県）
岐阜大学医学部附属病院（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | 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
Main results already published
Date of protocol fixation
| 2017 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
To analyze immune-related molecules using blood and tumor tissue samples
Management information
Registered date
| 2017 | Year | 10 | Month | 17 | Day |
Last modified on
| 2023 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033806
