UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061730 |
|---|---|
| Receipt number | R000070651 |
| Scientific Title | Perioperative treatment patterns and outcomes by risk of recurrence for patients with HER2-positive early breast cancer; A retrospective database study in Japan |
| Date of disclosure of the study information | 2026/05/30 |
| Last modified on | 2026/05/29 12:43:53 |
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Basic information
Public title
Perioperative treatment patterns and outcomes by risk of recurrence for patients with HER2-positive early breast cancer; A retrospective database study in Japan
Acronym
HER2 eBC DB Study
Scientific Title
Perioperative treatment patterns and outcomes by risk of recurrence for patients with HER2-positive early breast cancer; A retrospective database study in Japan
Scientific Title:Acronym
HER2 eBC DB Study
Region
| Japan |
Condition
Condition
HER2 positive breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To use a database to assess the implementation and efficacy of perioperative treatment for HER2-positive breast cancer patients stratified by disease stage
Basic objectives2
Others
Basic objectives -Others
Database study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To use a database to assess the implementation and efficacy of perioperative treatment for HER2-positive breast cancer patients stratified by disease stage
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients newly diagnosed with breast cancer between 1 October 2018 and 30 September 2024
2.Aged 18 years or older at the date of breast cancer diagnosis
3.Patients with breast cancer in clinical stage I to III
4.Patients with HER2-positive breast cancer
5. Underwent curative surgery for breast cancer during the period from the date of breast cancer diagnosis until 30 September 2024
Key exclusion criteria
1.Has a history of diagnosis of cancer other than breast cancer prior to the diagnosis of breast cancer
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Kimihiko |
| Middle name | |
| Last name | Tanizawa |
Organization
Daiichi Sankyo Co., Ltd.
Division name
Medical Evidence Department
Zip code
103-8426
Address
3-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan
TEL
03-6225-1111
contact_for_DSMA_JP@daiichisankyo.com
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Ezumi |
Organization
Daiichi Sankyo Co., Ltd.
Division name
Medical Evidence Department
Zip code
103-8426
Address
3-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan
TEL
03-6225-1111
Homepage URL
contact_for_DSMA_JP@daiichisankyo.com
Sponsor or person
Institute
Daiichi Sankyo Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Daiichi Sankyo Co., Ltd.
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
Daiichi Sankyo Co., Ltd.
Address
3-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan
Tel
03-6225-1111
contact_for_DSMA_JP@daiichisankyo.com
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
| 2026 | Year | 05 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 05 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cohort study using the database
Management information
Registered date
| 2026 | Year | 05 | Month | 29 | Day |
Last modified on
| 2026 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070651
