JBCRG-C07 (REIWA Study)｜Clinical Trials｜Japan Breast Cancer Research Group

JBCRG-C07 (REIWA Study): 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.

Objectives: (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. )

Subjects: Patients with stage IV or recurrent breast cancer who have distant metastases at registration

Endpoints: 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

Trial Period: Total research period: 5 years
Registration period: 3 years
Observation period: 2 years

Lead Principal Investigator: 1) Tohoku University Hospital 　Hiroshi Tada
2) Showa University Hospital 　Hiroko Masuda

Regimen: 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.

Clinical Trials