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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038065
Receipt No. R000043071
Scientific Title An observational study to evaluate the impact of the gene panel test FoundationOne 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 2021/07/15

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Basic information
Public title An observational study to evaluate the impact of the gene panel test FoundationOne CDx on treatment decision-making in metastatic and recurrent breast cancer throughout Japan as a whole.
Acronym JBCRG- C07 An observational study to evaluate the impact of the gene panel test on treatment decision-making in breast cancer throughout Japan as a whole. REIWA-Study
Scientific Title An observational study to evaluate the impact of the gene panel test FoundationOne CDx on treatment decision-making in metastatic and recurrent breast cancer throughout Japan as a whole.
Scientific Title:Acronym JBCRG- C07 An observational study to evaluate the impact of the gene panel test on treatment decision-making in breast cancer throughout Japan as a whole. 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 CDx 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, and also to evaluate the optimal timing when(after how many treatment lines) to receive F1CDx.
3.To evaluate the detection rate of actionable mutation by F1CDx.
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 are also applied to breast cancer patients
5.To evaluate the impact of drug resistant mutations detected by F1CDx 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 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 genome profiling results
The matched therapy is defined as the therapy determined by the expert panel according to the results of the F1CDx
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 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)
7.Percentage of treatment changes in relation to resistance information corresponding to genetic mutations after F1CDx
8.Reasons for decision-making of treatment options after F1CDx
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.)

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
Email 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/
Email office@jbcrg.jp

Sponsor
Institute Japan Breast Cancer Research Group
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
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
Email 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 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 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
2021 Year 07 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043071

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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