臨床研究等提出・公開システム

Date of registration	April. 03, 2024
Last modified on	Oct. 31, 2025
Trial ID	jRCT1031240010

Scientific Title	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))
Public Title	JBCRG-C11(CREA)

Contact for Scientific Queries	Name	Naito Yoichi
	Affiliation	National Cancer Center Hospital East
	Address	6-5-1 Kashiwanoha, Kashiwa-shi, Chiba
	Telephone	+81-4-7133-1111
	E-mail	ynaito@east.ncc.go.jp
Contact for Public Queries	Name	Naito Yoichi
	Affiliation	National Cancer Center Hospital East
	Address	6-5-1 Kashiwanoha, Kashiwa-shi, Chiba
	Telephone	+81-4-7133-1111
	E-mail	ynaito@east.ncc.go.jp

Recruitment status	Recruiting


Anticipated date of first enrollment		April. 03, 2024
Actual date of first enrollment		July. 16, 2024
Target sample size		100
Study Type		Observational
Key inclusion & exclusion 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	Patients who are judged by investigators to be ineligible for this study
	Age Minimum	18age old over
	Age Maximum	No limit
Health Condition(s) or Problem(s) Studied		HER2-positive advanced or metastatic breast cancer
Health Condition(s) Keyword		HER2-positive advanced or metastatic breast cancer
Primary Outcome(s)		proportion of complete response: CR at 1-year: 1-year CR
Secondary Outcome(s)		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)

Primary Sponsor	DAIICHI SANKYO COMPANY, LIMITED

Source of Monetary Support / Secondary Sponsor	DAIICHI SANKYO COMPANY, LIMITED
Secondary Sponsor	Not applicable

Name of Certified Review Board	National Cancer Center Institutional Review Board
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo, Tokyo
Telephone	+81-3-3542-2511
E-Mail	NCC_IRBoffice@ml.res.ncc.go.jp
Approval Status	Approval
Date of approval	Feb. 15, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
12	Oct. 31, 2025	(this page)	Changes
11	May. 27, 2025	Detail	Changes
10	May. 20, 2025	Detail	Changes
9	Oct. 21, 2024	Detail	Changes
8	Oct. 10, 2024	Detail	Changes
7	Sept. 30, 2024	Detail	Changes
6	Sept. 25, 2024	Detail	Changes
5	Aug. 20, 2024	Detail	Changes
4	June. 28, 2024	Detail	Changes
3	June. 03, 2024	Detail	Changes
2	April. 19, 2024	Detail	Changes
1	April. 03, 2024	Detail

List of change history