JBCRG-C11(CREA)

A multicenter prospective observational study in patients with HER2-positive advanced or metastatic breast cancer who achieved a Complete REsponse to trAstuzumab deruxtecan - A multicenter prospective observational study in patients with HER2-positive advanced or metastatic breast cancer who achieved a Complete REsponse to trAstuzumab deruxtecan (CREA)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1031240010

Enrollment

100

Registered

2024-04-03

Start date

2024-07-16

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

HER2-positive advanced or metastatic breast cancer HER2-positive advanced or metastatic breast cancer

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion 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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
proportion of complete response: CR at 1-year: 1-year CR	—

Secondary

Measure	Time frame
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)	—

Contacts

Public ContactYoichi Naito

National Cancer Center Hospital East

ynaito@east.ncc.go.jp+81-4-7133-1111

Outcome results