UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008983 |
|---|---|
| Receipt number | R000010534 |
| Scientific Title | Assessment of safety on trastuzumab with varied dilution solution volume in HER2 positive breast cancer |
| Date of disclosure of the study information | 2012/09/26 |
| Last modified on | 2013/06/29 22:01:27 |
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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(KBCSG03)
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(KBCSG03)
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
expanded access
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
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
Interventions/Control_2
level 2
After the first trastuzumab treatment: 6mg/kg of trastuzumab with 100 ml saline solution administered intravenously over 30 minutes
Interventions/Control_3
level 3
After the first trastuzumab treatment: 8mg/kg of trastuzumab with 100 ml saline solution administered intravenously over 30 minutes
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
6)Signed informed consent
Key exclusion criteria
1) with severe allergy to trastuzumab
2) Judjed ineligible based on physicians' decision
Target sample size
18
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
042-778-8111
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
042-778-8111
Homepage URL
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
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
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
| 2012 | Year | 09 | Month | 26 | 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
| 2012 | Year | 09 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
| 2013 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 26 | Day |
Last modified on
| 2013 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010534
