UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of safety on trastuzumab with varied dilution solution volume in HER2 positive breast cancer
Title of the study (Brief title)	Assessment of safety on trastuzumab with varied dilution solution volume in HER2 positive breast cancer
Region	Japan

Condition
Condition	Breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the safety on intravenously administered trastuzumab with vaired dilution solution volume and to determine the optimal concentration level
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	To evaluate MTD and RD
Key secondary outcomes	serious incidence of infusion reaction after the first treatment with trastuzumab

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	level 1 After the first trastuzumab treatment: 2mg/kg of trastuzumab with 100 ml saline solution administered intravenously over 30 minutes level 2 After the first trastuzumab treatment: 6mg/kg of trastuzumab with 100 ml saline solution administered intravenously over 30 minutes level 3 After the first trastuzumab treatment: 8mg/kg of trastuzumab with 100 ml saline solution administered intravenously over 30 minutes
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1) 20 years of age or more 2) HER2 overexpression confirmed by IHC or FISH 3) recieving neo-adjuvant or adjuvant therapy with trastuzumab 4) recieving mono trastuzumab treatment 5) Baseline left ventricular ejection fraction; above 50% based on echocardiography or MUGA scan in last 3months 6)Signed informed consent
Key exclusion criteria	1) with severe allergy to trastuzumab 2) Judjed ineligible based on physicians' decision
Target sample size	9

Research contact person
Name of lead principal investigator	Masahiko Watanabe
Organization	Kitasato University School of Medicine
Division name	Department of Surgery
Address	1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0375.
TEL	0427788111
Email	y-kosaka@med.kitasato-u.ac.jp

Public contact
Name of contact person	Norihiko Sengoku
Organization	Kitasato University School of Medicine
Division name	Department of Surgery
Address	1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0375.
TEL	0427788111
Homepage URL
Email	y-kosaka@med.kitasato-u.ac.jp

Sponsor
Institute	Kitasato University School of Medicine
Institute
Department

Funding Source
Organization	Kitasato University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	北里大学医学部（神奈川県）

Other administrative information
Date of disclosure of the study information	2018 Year 10 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 06 Month 15 Day
Anticipated trial start date	2012 Year 09 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 10 Month 12 Day
Last modified on	2018 Year 10 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010528