UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014750 |
|---|---|
| Receipt number | R000017148 |
| Scientific Title | The effect of trastuzumab emtansine (T-DM1) to the platelets for HER2-positive advanced breast cancer patients |
| Date of disclosure of the study information | 2014/08/07 |
| Last modified on | 2020/02/07 09:11:59 |
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Basic information
Public title
The effect of trastuzumab emtansine (T-DM1) to the platelets for HER2-positive advanced breast cancer patients
Acronym
The effect of trastuzumab emtansine (T-DM1) to the platelets for HER2-positive advanced breast cancer patients
Scientific Title
The effect of trastuzumab emtansine (T-DM1) to the platelets for HER2-positive advanced breast cancer patients
Scientific Title:Acronym
The effect of trastuzumab emtansine (T-DM1) to the platelets for HER2-positive advanced breast cancer patients
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the influence of T-DM1 on platelet
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The influence of T-DM1 on platelets
Key secondary outcomes
platelet production
platelet function
bone marrow involvement of breast cancer
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Male and Female
Key inclusion criteria
1. metastatic or advanced HER2 positive breast cancer
2. scheduled treatment with T-DM1
3. age >20 years
4. written informed consent
Key exclusion criteria
1. drug allergy to T-DM1 or trastuzumab
2. uncontrollable infection and diabetes mellitus
3. bleeding tendency
4. not suitable for participation with any other reasons
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Tamaru |
Organization
Mie University Hospital
Division name
Clinical Research Support Center
Zip code
514-8607
Address
2-174 Edobashi, Tsu city, Mie 514-8507, Japan
TEL
+81-59-231-5246
tamaru3@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Tamaru |
Organization
Mie University Hospital
Division name
Clinical Research Support Center
Zip code
514-8607
Address
2-174 Edobashi, Tsu city, Mie 514-8507, Japan
TEL
+81-59-231-5246
Homepage URL
tamaru3@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Hematology and Oncology, Mie University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Mie University Hospital Ethical Board
Address
2-174 Edobashi, Tsu city, Mie 514-8507, Japan
Tel
+81-59-231-5045
rinri-iin@doc.medic.mie-u.ac.jp
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
三重大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 07 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2014 | Year | 08 | Month | 03 | Day |
Last modified on
| 2020 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017148
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
