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.

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. - JBCRG-C07(REIWA Study)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000038065

Enrollment

600

Registered

2019-10-01

Start date

2019-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Patients with active invasive double cancer within 5 years or patients with active invasive double cancer that currently needs treatment.

Design outcomes

Primary

Measure	Time frame
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	—

Secondary

Measure	Time frame
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.)	—

Measure

Time frame

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.)

—

Countries

Japan

Contacts

Public ContactJun Fukase

Japan Breast Cancer Research Group (JBCRG) Head office

JBCRG-QAG@jbcrg.jp03-6264-8873

Outcome results