UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060989 |
|---|---|
| Receipt number | R000069791 |
| Scientific Title | Descriptive study on perioperative treatment in patients with HER2-positive breast cancer |
| Date of disclosure of the study information | 2026/03/24 |
| Last modified on | 2026/03/19 13:07:49 |
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Basic information
Public title
Study of real-world treatment before and after surgery for people with HER2-positive breast cancer
Acronym
HER2-positive breast cancer treatment pattern study
Scientific Title
Descriptive study on perioperative treatment in patients with HER2-positive breast cancer
Scientific Title:Acronym
HER2-positive breast cancer treatment pattern study
Region
| Japan |
Condition
Condition
HER2-positive breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To describe perioperative treatment patterns and treatment outcomes in HER2-positive breast cancer patients stratified by stage using J-CONNECT registry data.
Basic objectives2
Others
Basic objectives -Others
Descriptive evaluation of patient background, perioperative treatment patterns, pathological complete response, postoperative systemic therapy, and radiotherapy.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Number of patients receiving neoadjuvant systemic therapy between breast cancer diagnosis and 7 days before breast surgery, and patient background according to receipt of neoadjuvant systemic therapy.
Key secondary outcomes
Interval from diagnosis to neoadjuvant therapy, duration of neoadjuvant therapy, pathological complete response, interval from surgery to postoperative systemic therapy, use and duration of postoperative systemic therapy and radiotherapy, combinations of preoperative and postoperative treatments, and temporal changes in these patterns.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Newly diagnosed with breast cancer between 2018-10-01 and 2024-09-30; 2. Age 18 years or older at diagnosis; 3. Clinical stage I-IIIc at diagnosis; 4. HER2 positivity confirmed at any time during treatment; 5. Breast malignant tumor surgery performed by 2024-09-30.
Key exclusion criteria
Record of diagnosis of a non-breast cancer before the diagnosis of breast cancer.
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Okada |
Organization
Prime Research Institute for Medical RWD, Inc.
Division name
Data Science Office
Zip code
606-8501
Address
Room 205, Kyoto University International Science Innovation Building, 36-1 Yoshida-Honmachi, Sakyo-ku, Kyoto 606-8501, Japan
TEL
075-752-0330
masafumi.okada@ntt.com
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Okada |
Organization
Prime Research Institute for Medical RWD, Inc.
Division name
Data Science Office
Zip code
606-8501
Address
36-1 Yoshida-Honmachi, Sakyo-ku, Kyoto 606-8501, Japan
TEL
075-752-0330
Homepage URL
masafumi.okada@ntt.com
Sponsor or person
Institute
Prime Research Institute for Medical RWD, Inc.
Institute
Department
Personal name
Funding Source
Organization
Prime Research Institute for Medical RWD, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kyoto University
Name of secondary funder(s)
Daiichi Sankyo Co., Ltd.
IRB Contact (For public release)
Organization
MINS Institutional Review Board
Address
5-20-9-401 Mita, Minato-ku, Tokyo, Japan
Tel
03-6416-1868
npo-mins@j-irb.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
京都大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 24 | 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
No plan to share IPD
IPD sharing Plan description
There is no plan to share anonymized individual participant data. Only aggregate results that do not permit identification of individuals will be disclosed.
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective cohort study using registry data. The study uses the CONNECT2 / J-CONNECT registry involving 16 institutions led by Kyoto University Hospital. Eligible patients are those newly diagnosed with breast cancer between 2018-10-01 and 2024-09-30, aged 18 years or older at diagnosis, clinical stage I-IIIc, HER2-positive at any time during treatment, and who underwent breast malignant tumor surgery by 2024-09-30. Patients with a record of non-breast cancer diagnosed before breast cancer are excluded. Variables include neoadjuvant therapy, patient background, pathological complete response, postoperative systemic therapy, radiotherapy, and treatment patterns. The observation period is from 2018-01-01 to 2025-09-30.
Management information
Registered date
| 2026 | Year | 03 | Month | 19 | Day |
Last modified on
| 2026 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069791
