JBCRG-C11(CREA)

JRCT ID: jRCT1031240010

Registered date:03/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: HER2-positive advanced or metastatic breast cancer
• Date of first enrollment: 03/04/2024
• Target sample size: 100
• Study type: Observational

Outcome(s)

• Primary Outcome: proportion of complete response: CR at 1-year: 1-year CR

Secondary Outcome

1.Duration of complete response (DoCR)
2.Progression-free survival (PFS)
3.Overall survival (OS)
4.Time to treatment failure (TTF)
5.Time to next treatment (TTNT)
6.TTF2
7.TTNT2
8.Adverse events
9.Biomarkers (presence/absence of ctDNA detection)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable

Include criteria

1.Patients who have diagnosed with HER2 positive inoperable or recurrent breast cancer
2.Patients who are at least 18 years of age at the time of obtaining consent
3.Patients who have been judged by their physicians to achieve complete response on imaging after receiving T-DXd
4.Patients who have given written consent to participate in this study

• Exclude criteria: Patients who are judged by investigators to be ineligible for this study

Related Information

• Primary Sponsor: Naito Yoichi
• Secondary Sponsor: Masuda Norikazu,DAIICHI SANKYO COMPANY, LIMITED