UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041747
Receipt No. R000047375
Scientific Title Atezolizumab in patients with triple-negative breast cancer, multicenter observational study for treatment safety and efficacy (JBCRG-C08)
Date of disclosure of the study information 2020/10/01
Last modified on 2020/09/10

* 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 Atezolizumab in patients with triple-negative breast cancer, multicenter observational study for treatment safety and efficacy (JBCRG-C08)
Acronym JBCRG-C08 (ATTRIBUTE)
Scientific Title Atezolizumab in patients with triple-negative breast cancer, multicenter observational study for treatment safety and efficacy (JBCRG-C08)
Scientific Title:Acronym JBCRG-C08 (ATTRIBUTE)
Region
Japan

Condition
Condition Triple-negative Breast cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of treatment including atezolizumab in Japanese breast cancer patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary endpoint of this study is the incidence of adverse events as assessed by investigators.
In particular, immune-related adverse events in clinical practice are evaluated.
Key secondary outcomes 1) Overall Survival: OS
2) Overall Survival Rate (12,18,24 months)
3) Progression Free Survival: PFS
4) Progression Free Survival Rate (6,12,18,24 months)
5) Time to Treatment Failure: TTF
6) Treatment Success Rate (6,12,18,24 months)
7) Overall Response Rate: ORR
8) Duration of Response: DOR
9) Time to Response: TTR
10) Clinical Benefit Rate: CBR
11) Tumor Shrinkage Rate

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 1) >=20 years old
2) Inoperable or recurrent breast cancer with PD-L1-positive, hormone receptor-negative and HER2-negative
3)the patient who is planned to receive chemotherapy that includes atezolizumab as a clinical practice under national health insurance
4)Without history of hypersensitivity to the components of atezolizumab
5) Less than 2 regimens of systemic chemotherapy for inoperable or recurrent breast cancer
6) Written agreement to the enrollment for this study
Key exclusion criteria None
Target sample size 150

Research contact person
Name of lead principal investigator
1st name 1)Tatsunori 2)Naoki
Middle name
Last name 1)Shimoi 2)Niikura
Organization 1)National Cancer Center Hospital 2)Tokai University School of Medicine
Division name 1) Department of Breast and Medical Oncology 2)Department of Breast and Endocrine Surgery
Zip code 104-0045
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL 03-3542-2511
Email tshimoi@ncc.go.jp

Public contact
Name of contact person
1st name Katsumasa
Middle name
Last name Kuroi
Organization Japan Breast Cancer Research Group (JBCRG)
Division name administrative office
Zip code 103-0016
Address 9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, Japan
TEL 03-6264-8873
Homepage URL http://www.jbcrg.jp/
Email office@jbcrg.jp

Sponsor
Institute Japan Breast Cancer Research Group (JBCRG)
Institute
Department

Funding Source
Organization CHUGAI PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor CHUGAI PHARMACEUTICAL CO., LTD.
Name of secondary funder(s)

IRB Contact (For public release)
Organization Clinical Research Administration Office ,Tokai University Hospital.
Address 143 Shimokasuya, Isehara-shi, Kanagawa 259-1193 JAPAN
Tel 0463-93-1121
Email tokai-rinsho@ml.tokai-u.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 国立がん研究センター中央病院(東京都)、東海大学医学部(神奈川県)

Other administrative information
Date of disclosure of the study information
2020 Year 10 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 Preinitiation
Date of protocol fixation
2020 Year 09 Month 09 Day
Date of IRB
Anticipated trial start date
2020 Year 12 Month 01 Day
Last follow-up date
2025 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study
Trial period:
Enrollment period end date (Schedule): 3 years from the date of enrollment of the first study subjects or until the target number of cases is reached, whichever is earlier.
The end of the observation period: 4 years from the first enrolment date or up to 2 years from the last enrolment date, whichever is earlier.
Total study period: The period from the date of JBCRG council's approval to the date of approval of the trial summary report.
Atezolizumab has been used in the treatment of limited number of breast cancer patients in Japan. Large-scale data on safety and efficacy, predictive markers for efficacy, predictive markers for irAE, and management methods for safe use of atezolizumab in Japanese clinical practice have not been established.
Since this study is an observational study in clinical practice, the confirmatory results cannot be avairable. However, as an exploratory alnaysis, it is expected that some key data will lead to solutions to these issues.

Management information
Registered date
2020 Year 09 Month 10 Day
Last modified on
2020 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047375

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.