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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034475
Receipt No. R000010528
Scientific Title Assessment of safety on trastuzumab with varied dilution solution volume in HER2 positive breast cancer
Date of disclosure of the study information 2018/10/12
Last modified on 2018/10/12

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Basic information
Public title Assessment of safety on trastuzumab with varied dilution solution volume in HER2 positive breast cancer
Acronym Assessment of safety on trastuzumab with varied dilution solution volume in HER2 positive breast cancer
Scientific Title Assessment of safety on trastuzumab with varied dilution solution volume in HER2 positive breast cancer
Scientific Title:Acronym 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
1st name
Middle name
Last name Masahiko Watanabe
Organization Kitasato University School of Medicine
Division name Department of Surgery
Zip code
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
1st name
Middle name
Last name Norihiko Sengoku
Organization Kitasato University School of Medicine
Division name Department of Surgery
Zip code
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)

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 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

Related information
URL releasing protocol
Publication of results Published

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
2012 Year 06 Month 15 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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