臨床研究等提出・公開システム

Date of registration	May. 16, 2019
Last modified on	Mar. 30, 2023
Trial ID	jRCT1080224684

Scientific Title	TR study of "A basket trial of DS-8201a, a novel HER2-targeted antibody-drug conjugate, for HER2 amplified solid tumors identified by ctDNA analysis"
Public Title	HERALD TR study

Contact for Scientific Queries	Name	Nakamura Yoshiaki
	Contact Name for Scientific Queries	National Cancer Center Hospital East
	Address	6-5-1, Kashiwanoha, Kashiwa-shi, Chiba, 277-8577, Japan
	Phone Number	+81-4-7133-1111
	E-mail Address	HERALD_core@east.ncc.go.jp

Contact for Public Queries	Name	clinical trial coordinating committee
	Contact Name for Public Queries	National Cancer Center Hospital East
	Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
	Phone Number	+81-4-7133-1111
	E-mail Address	HERALD_core@east.ncc.go.jp

Recruitment Status	completed

Date of First Enrolment		Dec. 05, 2019
Target Sample Size		65
Study Type		Interventional
Study Design	Study Design	exploratory research
Study Design	Objective	other
Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	1.Enrolled in HERALD trial. 2.Informed consent for participation in the HERALD TR study is obtained at the discretion of the patient.
	Exclusion Criteria	-
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		solid malignancies
Intervention(s)		investigational material(s) Generic name etc : DS-8201a INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : DS-8201a (5.4mg/kg) is administrated i.v. on day1, repeated every 21 days. control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		exploratory Analysis of cancer-related genetic abnormalities Analysis of Protein expression Analysis of mRNA and cfRNA expression Analysis of circulating tumor cells
Secondary Outcome		other -

Primary Sponsor	National Cancer Center Hospital East
Secondary Sponsor	DAIICHI SANKYO Co., Ltd

Name of Funding Organization	DAIICHI SANKYO Co., Ltd
Name of Research Funding	-

Name	National Cancer Center Institutional Review Board
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
Phone Number	+81-3-3542-2511
E-mail Address	NCC_IRBoffice@ml.res.ncc.go.jp
Status of Review	Approval
Date of Approval	Aug. 06, 2019

Secondary ID No.	JapicCTI-194758
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
6	Mar. 30, 2023	(this page)	Changes
5	Nov. 10, 2022	Detail	Changes
4	Nov. 22, 2021	Detail	Changes
3	Mar. 27, 2020	Detail	Changes
2	Dec. 09, 2019	Detail	Changes
1	May. 17, 2019	Detail

List of change history