UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063177 |
|---|---|
| Receipt number | R000071616 |
| Scientific Title | A multicenter retrospective observational study to investigate the real-world practices of Ki67 assessment and characteristics of patients with hormone receptor-positive, HER2 negative early breast cancer |
| Date of disclosure of the study information | 2026/10/05 |
| Last modified on | 2026/10/05 08:52:11 |
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Basic information
Public title
Study of Ki67 assessment practices and patient characteristics in hormone receptor-positive, HER2-negative early breast cancer
Acronym
Ki-REAL
Scientific Title
A multicenter retrospective observational study to investigate the real-world practices of Ki67 assessment and characteristics of patients with hormone receptor-positive, HER2 negative early breast cancer
Scientific Title:Acronym
Ki-REAL
Region
| Japan |
Condition
Condition
Hormone receptor-positive, HER2-negative early breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To describe real-world Ki67 assessment practices for HR-positive, HER2-negative early breast cancer in Japan and retrospectively characterize patient factors associated with recurrence risk using medical records.
Basic objectives2
Others
Basic objectives -Others
Descriptive epidemiologic assessment of Ki67 testing practices and patient characteristics
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Part A: Numbers and proportions of participating institutions by Ki67 testing site, assessed area, primary antibody, reporting format, and related practices.
2) Part B: Summary statistics and proportions describing recurrence-risk-related characteristics of patients with HR-positive, HER2-negative early breast cancer.
Key secondary outcomes
To evaluate distributions of high-risk factors, proportions of Ki67 specimen types, and concordance of Ki67 results between specimens in groups stratified by testing method and result.
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
Female
Key inclusion criteria
1. Female and aged 18 years or older at breast cancer diagnosis.
2. Histologically confirmed invasive breast cancer.
3. ER-positive or PgR-positive (at least 1% IHC-positive cells or Allred score at least 3).
4. HER2-negative (IHC 0/1+ or FISH/DISH negative).
5. Surgery as initial treatment for stage II-III HR-positive, HER2-negative breast cancer.
6. Standard adjuvant endocrine therapy started between 1 January 2017 and 31 December 2022.
7. Ki67 measured before adjuvant endocrine therapy, with a result available.
Key exclusion criteria
1. Missing medical-record data prevents collection of key study variables.
2. Treatment differs from standard care due to participation in a clinical trial during the target period, except for the monarchE trial.
3. Otherwise considered unsuitable by the physician.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Kojima |
Organization
Showa Medical University
Division name
Institute of Clinical Genomics
Zip code
142-8555
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555, Japan
TEL
03-3784-8261
yasucozy_8@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Hitomi |
| Middle name | |
| Last name | Sakai |
Organization
Showa Medical University
Division name
Institute for Advanced Cancer Treatment
Zip code
142-8555
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555, Japan
TEL
03-3784-8145
Homepage URL
sakai-h@med.showa-u.ac.jp
Sponsor or person
Institute
Showa Medical University
Institute
Department
Personal name
Funding Source
Organization
Eli Lilly Japan K.K.
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
Showa Medical University Ethics Committee for Research Involving Human Subjects
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555, Japan
Tel
03-3784-8129
m-rinri@ofc.showa-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
昭和医科大学病院（東京都）、東京医科大学病院（東京都）、国立病院機構東京医療センター（東京都）、京都大学医学部附属病院（京都府）、名古屋大学医学部附属病院（愛知県）、北海道大学病院（北海道）、福島県立医科大学附属病院（福島県）、筑波大学附属病院（茨城県）、岡山大学病院（岡山県）、国立病院機構四国がんセンター（愛媛県）、聖路加国際病院（東京都）、八尾市立病院（大阪府）、慶應義塾大学病院（東京都）、三重大学医学部附属病院（三重県）、浜松医科大学医学部附属病院（静岡県）、富山大学附属病院（富山県）、がん研究会有明病院（東京都）、国立病院機構大阪医療センター（大阪府）、相良病院（鹿児島県）、横浜市立大学附属病院（神奈川県）、静岡県立総合病院（静岡県）、横浜市立大学附属市民総合医療センター（神奈川県）、神奈川県立がんセンター（神奈川県）、昭和医科大学横浜市北部病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This multicenter observational study comprises an institutional survey (Part A) and a retrospective medical-record review of patient characteristics (Part B). Individual consent will not be obtained; study information will be disclosed and an opt-out opportunity provided.
Management information
Registered date
| 2026 | Year | 10 | Month | 05 | Day |
Last modified on
| 2026 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071616
