臨床研究等提出・公開システム

Date of registration	Jan. 29, 2019
Last modified on	July. 21, 2022
Trial ID	jRCT2080224535

Scientific Title
Public Title

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number	-
	E-mail Address	JPCT@msd.com

Contact for Public Queries	Name
	Contact Name for Public Queries
	Address
	Phone Number	-
	E-mail Address	JPCT@msd.com

Recruitment Status	completed

Date of First Enrolment		Feb. 15, 2019
Target Sample Size		1140
Study Type		Interventional
Study Design	Study Design
Study Design	Objective	treatment purpose
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria
	Exclusion Criteria
	Minimum Age	18age old over
	Maximum Age	No limit
	Gender	Female
Health Condition or Problem Studied
Intervention(s)		investigational material(s) Generic name etc : INN of investigational material : pembrolizumab, paclitaxel, doxorubicin hydrochloride, epirubicin, cyclophosphamide Therapeutic category code : 42- Antineoplastic agents Dosage and Administration for Investigational material : control material(s) Generic name etc : INN of investigational material : paclitaxel, doxorubicin hydrochloride, epirubicin, cyclophosphamide Therapeutic category code : 42- Antineoplastic agents Dosage and Administration for Investigational material :
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy
Secondary Outcome		safety efficacy

Primary Sponsor
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB	-
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	Aug. 22, 2018

Secondary ID No.	NCT03725059
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-194604
Name of Other Registries

Countries / Regions of Recruitment	Japan/Asia except Japan/North America/Europe

History of Changes

No	Publication date
3	July. 21, 2022	(this page)	Changes
2	June. 02, 2022	Detail	Changes
1	Feb. 06, 2019	Detail

List of change history