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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029590
Receipt No. 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 2019/01/29

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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
Middle name
Last name Yukinori Ozaki
Organization Toranomon Hospital
Division name Department of Medical Oncology
Zip code
Address 2-2-2 Toranomon Minato-ku,Tokyo
TEL 03-3588-1111
Email 1755ozaki@toranomon.gr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichiro Nakamura
Organization West Japan Oncology Group
Division name WJOG datacenter
Zip code
Address Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN
TEL 06-6633-7400
Homepage URL
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
Institute
Department

Funding Source
Organization ONO PHARMACEUTICAL CO., LTD
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
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 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 No longer recruiting
Date of protocol fixation
2017 Year 10 Month 06 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2019 Year 01 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033806

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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