UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059883 |
|---|---|
| Receipt number | R000068487 |
| Scientific Title | Observational Study on the Efficacy and Safety of Accelerated Partial Breast Irradiation after Breast-Conserving Surgery |
| Date of disclosure of the study information | 2025/11/26 |
| Last modified on | 2025/11/26 12:18:23 |
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Basic information
Public title
Observational Study on the Efficacy and Safety of Accelerated Partial Breast Irradiation after Breast-Conserving Surgery
Acronym
Observational Study of Accelerated Partial Breast Irradiation
Scientific Title
Observational Study on the Efficacy and Safety of Accelerated Partial Breast Irradiation after Breast-Conserving Surgery
Scientific Title:Acronym
Observational Study of Accelerated Partial Breast Irradiation
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prospectively investigate the implementation status and outcomes of accelerated partial breast irradiation in patients after breast-conserving surgery, and to clarify its efficacy and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of adverse events occurrence
Key secondary outcomes
Local recurrence-free survival
Overall survival
Cosmetic 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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
Invasive breast cancer:
Tumor size 3cm or less
No lymphnode metastasis
No lymphovascular invasion
Negative surgical margins
Ductal carcinoma in situ:
Tumor size 3cm or less
Negative surgical margins
Key exclusion criteria
Invasive lobular carcinoma
Known pathogenic variants in breast cancer susceptibility genes (BRCA) 1/2
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Ishikura |
Organization
St. Luke's International University, St. Luke's International Hospital
Division name
Department of Radiation Oncology
Zip code
104-8560
Address
9-1 Akashi-cho, Chuo-ku, Tokyo, Japan
TEL
03-5550-7006
sishikur-ncche@umin.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Ishikura |
Organization
St. Luke's International University, St. Luke's International Hospital
Division name
Department of Radiation Oncology
Zip code
104-8560
Address
9-1 Akashi-cho, Chuo-ku, Tokyo, Japan
TEL
03-5550-7006
Homepage URL
sishikur-ncche@umin.ac.jp
Sponsor or person
Institute
St. Luke's International University
Institute
Department
Personal name
Satoshi Ishikura
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
Institutional Review Board of St. Luke's International University
Address
10-1 Akashi-cho, Chuo-ku, Tokyo, Japan
Tel
03-5550-2423
kenkyukikaku@luke.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 16 | Day |
Last follow-up date
| 2032 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After breast-conserving surgery for breast cancer, radiotherapy is widely performed to prevent local recurrence, with whole-breast irradiation having traditionally been the standard approach. However, for low-risk cases that meet certain criteria, partial breast irradiation targeting the tumor bed has become feasible, with reports of reduced adverse effects. Among these, accelerated partial breast irradiation (APBI), which shortens the treatment period, has attracted attention as an option that can reduce the burden on patients.
According to the 2025 edition of the NCCN Guidelines, APBI is accepted as an alternative to whole-breast irradiation for early-stage breast cancer with T1-2, N0, and clear surgical margins, and it has already been established as one of the standard treatments in Western countries. In contrast, its adoption in Japan remains limited, and further accumulation of evidence regarding its efficacy and safety in clinical practice is required.
This study aims to prospectively observe patients receiving radiotherapy after breast-conserving surgery at our institution and to evaluate the efficacy and safety of APBI.
It should be noted that the 2022 edition of the Japanese Breast Cancer Clinical Practice Guidelines states that APBI is conditionally recommended, restricted to low-risk cases in non-young patients, and should be performed only in facilities with established quality assurance systems.
Management information
Registered date
| 2025 | Year | 11 | Month | 26 | Day |
Last modified on
| 2025 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068487
