UMIN-CTR Clinical Trial

Basic information
Public title	Feasibility study of a short Trastuzumab infusion in patients with breast cancer.
Acronym	Feasibility study of a short Trastuzumab infusion in patients with breast cancer.
Scientific Title	Feasibility study of a short Trastuzumab infusion in patients with breast cancer.
Scientific Title:Acronym	Feasibility study of a short Trastuzumab infusion in patients with breast cancer.
Region	Japan

Condition
Condition	breast cancer
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety profile of a short infusion of Trastuzumab in Japanese breast cancer patients.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Having onset of hypersensitivity reaction or not
Key secondary outcomes	grade of infusion related reaction(CTCAE v.4.0),feasibility,causality of between hypersensitivity and BMI and stage

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 Maneuver
Interventions/Control_1	Trastuzumab is administered in 0.2mg/kg/min.
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)HER2 positive(either 3+ overexpression by IHC or positive by FISH) breast cancer of stage 1-3 2)outpatients 3)Age 20 years and above 4)ECOG PS 0-3 5)No prior therapy of trastuzumab 6)Written informed consent
Key exclusion criteria	1)Systemic administration of corticosteroids 2)At the same time, used other molecular target drugs 3)Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Target sample size	20

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Akiko Konomatsu
Organization	NIPPON MEDICAL SCHOOL MUSASHI KOSUGI HOSPITAL
Division name	Pharmacy
Zip code
Address	1-396,KOSUGI-CHO NAKAHARAKU,KAWASAKI KANAGAWA
TEL	044-733-5181
Email	akk-koo@nms.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Akiko Konomatsu
Organization	NIPPON MEDICAL SCHOOL MUSASHI KOSUGI HOSPITAL
Division name	Pharmacy
Zip code
Address	1-396,KOSUGI-CHO NAKAHARAKU,KAWASAKI KANAGAWA
TEL	044-733-5181
Homepage URL
Email	akk-koo@nms.ac.jp

Sponsor
Institute	NIPPON MEDICAL SCHOOL MUSASHI KOSUGI HOSPITAL
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	日本医科大学武蔵杉病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 21 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 07 Day
Date of IRB	2015 Year 05 Month 07 Day
Anticipated trial start date	2015 Year 06 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 07 Month 13 Day
Last modified on	2019 Year 04 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020788