UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038065 |
|---|---|
| Receipt number | R000043071 |
| Scientific Title | An observational study to evaluate the impact of the gene panel test FoundationOne CDx or FoundationOne Liquid CDx on treatment decision-making in metastatic and recurrent breast cancer throughout Japan as a whole. |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2023/03/27 15:27:44 |
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Basic information
Public title
An observational study to evaluate the impact of the gene panel test FoundationOne CDx or FoundationOne Liquid CDx on treatment decision-making in metastatic and recurrent breast cancer throughout Japan as a whole.
Acronym
JBCRG- C07 (REIWA-Study)
Scientific Title
An observational study to evaluate the impact of the gene panel test FoundationOne CDx or FoundationOne Liquid CDx on treatment decision-making in metastatic and recurrent breast cancer throughout Japan as a whole.
Scientific Title:Acronym
JBCRG-C07(REIWA Study)
Region
| Japan |
Condition
Condition
Patients with stage IV or recurrent breast cancer who have distant metastases at registration
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
1.To evaluate the access rate to matched therapies corresponding to gene mutations detected by FoundationOne (F1CDx) or FoundationOne Liquid CDx (F1LCDx) genome profiling which is covered by Japanese medical insurance.
2.To compare the Overall survival among those who received matched therapies and those who did not after performing F1CDx or F1LCDx, and also to evaluate the optimal timing when(after how many treatment lines) to receive F1CDx or F1LCDx.
3.To evaluate the detection rate of actionable mutation by F1CDx or F1LCDx.
4.To assess the improvement in drug accessibility to matched therapies if assuming an insurance system where all target treatments corresponding to actionable gene mutations detected by F1CDx or F1LCDx are also applied to breast cancer patients
5.To evaluate the impact of drug resistant mutations detected by F1CDx or F1LCDx on changing to other treatment options.
6.To identify the factors affecting the accessibility to matched therapy based on the comparison of access rate to matched therapies by areas (urban and rural) and type of healthcare facilities (genomic core hospitals, partner hospitals, etc.)
Basic objectives2
Others
Basic objectives -Others
To evaluate the accessibility to matched therapies that were recommended by FoundationOne CDx or FoundationOne Liquid CDx genome profiling results and the access rate to clinical trials.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate the accessibility to matched therapies and the access rate to clinical trials that were recommended by FoundationOne CDx or FoundationOne Liquid CDx genome profiling results
The matched therapy is defined as the therapy determined by the expert panel according to the results of the F1CDx or F1LCDx
Clinical trials include either single arm development studies or clinical trials
Key secondary outcomes
1.Overall survival: OS
2.The rate of performed matched targeted therapies corresponding to actionable gene mutations during the entire treatment period.
3.Detection rate of actionable gene mutation.
4.Proportion of drugs (including those used in other cancers) that can be used under the Japanese insurance system as matched therapies corresponding to actionable gene mutations.
5.Types of targeted therapies corresponding to actionable gene mutations (including investigational drugs not available in Japan. Also including HER2 status convert cases that were identified after F1CDx or F1LCDx and were recommended anti-HER2 targeted therapies)
6.Types of resistance information corresponding to gene mutations (including cases in which anti-HER2 treatment was not recommended, although it was evaluated as HER2 positive before F1CDx or F1LCDx)
7.Percentage of treatment changes in relation to resistance information corresponding to genetic mutations after F1CDx or F1LCDx
8.Reasons for decision-making of treatment options after F1CDx or F1LCDx
9.The rate of performed matched therapies by region (Hokkaido, Tohoku, Kanto, Chubu, Kinki, Chugoku, Shikoku, Kyushu Okinawa), facility size (number of beds), and type of facility (genomic core hospital, partner hospital, etc.)
10.The rate of performed matched therapies by region (Hokkaido, Tohoku, Kanto, Chubu, Kinki, Chugoku, Shikoku, Kyushu Okinawa), facility size (number of beds), and type of facility (genomic core hospital, partner hospital, etc.)
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
1.Patients with histologically confirmed breast cancer.
2.Patients with stage IV or recurrent breast cancer who have distant metastases at registration
3.Patients who received explanation of F1CDx and agreed to perform it first, and then agreed to participate in this observation study.
4.Patients with a prognosis of 3 months or more
Key exclusion criteria
Patients with active invasive double cancer within 5 years or patients with active invasive double cancer that currently needs treatment.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | 1)Hiroshi,2)Hiroko |
| Middle name | |
| Last name | 1)Tada,2)Masuda |
Organization
1)Tohoku University,2)Showa University
Division name
1)Breast and endocrine surgery,2)Breast Surgical oncology/Advanced Cancer Translational Research institution
Zip code
980-8574
Address
1-1 Seiryo-machi Aoba-ku Sendai Miyagi 980-8574
TEL
022-717-7214
hiroshi-tada@med.tohoku.ac.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
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of Showa University school of Medicine
Address
1-5-8 Hatanodai Shinagawa-ku Tokyo, 142-8666
Tel
03-3784-8129
m-rinri@ofc.showa-u.ac.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
東北大学病院（宮城県）、昭和大学病院（東京都）、愛知県がんセンター（愛知県）、国立がん研究センター東病院（東京都）、大阪医療センター（大阪府）、岡山大学病院（岡山県）、名古屋市立大学病院（愛知県）、がん研究会有明病院（東京都）、国立がん研究センター 東病院（東京都）、虎の門病院（東京都）、国立がん研究センター中央病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | 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
| 2019 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design:
We evaluate the patients with stage IV or recurrent breast cancer who have distant metastases at registration. We register the patients with each cohort by subtype ( Luminal/HER2/TNBC).
Patients data will be registered in EDC at the time of registration, after the F1CDx or F1LCDx result is returned, and at the end of the observation period. Total research period: 5 years
Registration period: 3 years
Observation period: 2 years
Observation items:
Basic information, Treatment regimens; presence / absence of matched therapy according to the results of the F1CDx or F1LCDx and expert panel. Description of the reason for treatment selection, All treatment regimens and periods during this observational study, Survival information, etc.
Management information
Registered date
| 2019 | Year | 09 | Month | 20 | Day |
Last modified on
| 2023 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043071
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| Registered date | File name |
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