UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041747 |
|---|---|
| Receipt number | 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 | 2023/02/22 16:31:31 |
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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 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
tshimoi@ncc.go.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Fukase |
Organization
Japan Breast Cancer Research Group (JBCRG)
Division name
Head office
Zip code
103-0016
Address
9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, Japan
TEL
03-6264-8873
Homepage URL
https://www.jbcrg.jp/
office@jbcrg.jp
Sponsor or person
Institute
Japan Breast Cancer Research Group (JBCRG)
Institute
Department
Personal name
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
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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 09 | Day |
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
| 2023 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047375
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
