UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037747 |
|---|---|
| Receipt number | R000043048 |
| Scientific Title | The Real-World Clinical Benefits of Following Therapy after Trastuzumab Emtansine (T-DM1) for HER2-positive Metastatic Breast Cancer: A Multicentral Cohort Study(WJOG12519B) |
| Date of disclosure of the study information | 2019/08/26 |
| Last modified on | 2021/02/18 13:11:16 |
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Basic information
Public title
The Real-World Clinical Benefits of Following Therapy after Trastuzumab Emtansine (T-DM1) for HER2-positive Metastatic Breast Cancer: A Multicentral Cohort Study(WJOG12519B)
Acronym
Therapy after Trastuzumab Emtansine (T-DM1) for HER2-positive metastatic breast cancer(WJOG12519B)
Scientific Title
The Real-World Clinical Benefits of Following Therapy after Trastuzumab Emtansine (T-DM1) for HER2-positive Metastatic Breast Cancer: A Multicentral Cohort Study(WJOG12519B)
Scientific Title:Acronym
Therapy after Trastuzumab Emtansine (T-DM1) for HER2-positive metastatic breast cancer(WJOG12519B)
Region
| Japan |
Condition
Condition
HER2-positive metastatic breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the types of treatment and efficacy of treatment after trastuzumab emtansine (T-DM1) in metastatic HER2-positive breast cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response rate of the next treatment after trastuzumab emtansine (T-DM1)
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. It has been diagnosed as HER2-positive breast cancer by the pathological diagnosis.
2. It has been diagnosed with metastatic breast cancer (Stage IV breast cancer or recurrent breast cancer).
3. Between January 1st, 2014 and December 31st, 2018, at least one line of following treatment has begun after the first trastuzumeb emtansine (T-DM1) treatment for Stage IV breast cancer or recurrent breast cancer.
Key exclusion criteria
1. The case where the following treatment after the first trastuzumeb emtansine (T-DM1) is registered in the clinical trial of derug development
2. Patients judged to be inappropriate as targets by the judgment of other doctors
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takamichi |
| Middle name | |
| Last name | Yokoe |
Organization
National Cancer Center Hospital East
Division name
Department of Breast Surgery
Zip code
277-8577
Address
ashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
tyokoe@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Nakamura |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
556-0016
Address
Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO COMPANY, LIMITED
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Hospital East
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
Tel
04-7133-1111
tyokoe@east.ncc.go.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | 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
| 2019 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To clarify the types of treatment and efficacy of treatment after trastuzumab emtansine (T-DM1) in metastatic HER2-positive breast cancer
Management information
Registered date
| 2019 | Year | 08 | Month | 20 | Day |
Last modified on
| 2021 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043048
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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