臨床研究等提出・公開システム

Date of registration	Mar. 02, 2012
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221730

Scientific Title	Phase 1b study of U3-1287 in combination with trastuzumab plus paclitaxel in patients with HER2-positive metastatic breast cancer (MBC)
Public Title	Phase 1b study of U3-1287 in combination with trastuzumab plus paclitaxel in patients with HER2-positive metastatic breast cancer (MBC)

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	DAIICHI SANKYO Co.,Ltd
	Address	dsclinicaltrial@daiichisankyo.co.jp
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		36
Study Type		Interventional
Study Design	Study Design	Open-label, Phase 1b Study
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	- Histologically or cytologically confirmed invasive carcinoma of the breast with metastatic disease - Documented HER2-positive disease - ECOG performance status: 0 or 1
	Exclusion Criteria	- Has history of anti-HER3 therapy - Total dose of anthracyclines >= 360mg/m2 in prior treatment - Patients with active other malignancies - Has history or complication of interstitial lung disease by radiographic examination - Left ventricular ejection fraction(LVEF) < 55% at enrollment or history of LVEF decline >= 10% from base line on prior trastuzumab therapy and the decline to <55% - Has brain metastasis with clinical symptoms or requiring treatment - Has history of serious drug hypersensitivity reaction such as anaphylaxis
	Minimum Age	20age old over
	Maximum Age	75age old under
	Gender	Female
Health Condition or Problem Studied		HER2-positive MBC
Intervention(s)		investigational material(s) Generic name etc : U3-1287 INN of investigational material : Patritumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : U3-1287
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Safety and pharmacokinetics NCI-CTC ver. 4.03
Secondary Outcome		- Incidence of anti-U3-1287 antibody - Preliminary assessment of anti-tumor activity of U3-1287 - Exploratory study on U3-1287-related biomarker RECIST ver. 1.1

Primary Sponsor	DAIICHISANKYO Co.,Ltd.
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
Date of Approval by IRB

Secondary ID No.	JapicCTI-121772
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
13	Dec. 17, 2018	(this page)	Changes
12	June. 12, 2018	Detail	Changes
11	June. 12, 2018	Detail	Changes
10	July. 19, 2017	Detail	Changes
9	July. 19, 2017	Detail	Changes
8	June. 13, 2016	Detail	Changes
7	June. 13, 2016	Detail	Changes
6	April. 17, 2014	Detail	Changes
5	April. 17, 2014	Detail	Changes
4	Mar. 13, 2013	Detail	Changes
3	Mar. 13, 2013	Detail	Changes
2	Mar. 02, 2012	Detail	Changes
1	Mar. 02, 2012	Detail

List of change history