UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061042 |
|---|---|
| Receipt number | R000069708 |
| Scientific Title | Ultra-Hypofractionated Sequential Boost Following Ultra-Hypofractionated Whole-Breast Irradiation After Breast-Conserving Surgery: A Phase II Safety Study |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/24 19:01:22 |
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Basic information
Public title
Ultra-Hypofractionated Sequential Boost Following Ultra-Hypofractionated Whole-Breast Irradiation After Breast-Conserving Surgery: A Phase II Safety Study (UPBEAT-Boost Trial)
Acronym
UPBEAT-Boost Trial: Safety Study of Ultra-Hypofractionated Sequential Boost After Whole-Breast Irradiation
Scientific Title
Ultra-Hypofractionated Sequential Boost Following Ultra-Hypofractionated Whole-Breast Irradiation After Breast-Conserving Surgery: A Phase II Safety Study
Scientific Title:Acronym
UPBEAT-Boost Trial
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of a radiation regimen consisting of ultra-hypofractionated whole-breast irradiation (26 Gy in 5 fractions over 5 days) followed by a sequential boost irradiation (5.2 Gy in 1 fraction over 1 day) in patients requiring boost irradiation after breast-conserving surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence of acute adverse events (Grade >=2) within 3 months after the start of radiotherapy
Key secondary outcomes
Key secondary outcomes include overall survival, disease-free survival, ipsilateral breast tumor recurrence (IBTR)-free survival, ipsilateral breast tumor recurrence rate, and the incidence of late adverse events (Grade >=2).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Ultra-hypofractionated whole-breast irradiation (26 Gy in 5 fractions over 5 days) followed by sequential boost irradiation (5.2 Gy in 1 fraction over 1 day) after breast-conserving surgery.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) No distant metastasis is detected in all preoperative examinations.
2) Patients who have undergone breast-conserving surgery.
3) Postoperative pathological findings meet the following criteria
1. Histological type is invasive carcinoma or ductal carcinoma in situ.
2. Pathological stage corresponds to pT0-3 pN0-1.
The following cases are also eligible.
- pNX cases with cTisN0 in whom sentinel lymph node biopsy is judged unnecessary.
- Cases in which neoadjuvant systemic therapy was performed and the final pathology is ypT0.
* Cases with pT0 without neoadjuvant systemic therapy are not eligible.
4) Patients who meet either of the following conditions and are indicated for boost irradiation
1. Positive or close surgical margin in the pathological diagnosis.
2. Age <=50 years.
5) The interval between surgery and the start of radiotherapy is <=140 days (20 weeks). If re-excision is performed, the date of re-excision is regarded as the date of surgery. If adjuvant chemotherapy is administered, chemotherapy must be completed before the start of radiotherapy.
6) Female patients aged >=20 years.
7) Performance status (ECOG) of 0 or 1.
8) No prior history of radiotherapy to the chest. However, prior irradiation to the contralateral breast is permitted.
9) Written informed consent for participation in the study is obtained from the patient.
Key exclusion criteria
1) Presence of active multiple primary cancers (synchronous cancers or metachronous cancers with a disease-free interval of <=5 years). However, lesions considered cured by local treatment with a prognosis comparable to carcinoma in situ and an extremely low risk of cancer-related death, as well as lesions equivalent to intramucosal carcinoma, are not regarded as active multiple primary cancers.
2) Presence of infection requiring systemic treatment.
3) Fever >=38 C.
4) Pregnant women, women who may be pregnant, or women who are breastfeeding.
5) Presence of psychiatric disease or psychiatric symptoms judged to make participation in the study difficult.
6) Diabetes mellitus requiring continuous insulin treatment or poorly controlled diabetes mellitus (HbA1c >=7.0% as a guideline).
7) Presence of interstitial pneumonia, pulmonary fibrosis, or severe emphysema.
8) Continuous systemic steroid therapy (oral or intravenous).
9) Receiving immunosuppressive therapy due to active collagen disease.
10) History of any of the following: severe heart disease, heart failure, myocardial infarction within 6 months, or angina attack within 6 months.
11) Cases judged by the principal investigator or sub-investigator to be unsuitable for participation in this study.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Itaru |
| Middle name | |
| Last name | Ikeda |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Radiation Oncology,
Zip code
650-0047
Address
2-1-1 Minatojima Minamimachi, Chuo-ku, Kobe
TEL
078-302-4321
itaru@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Takamasa |
| Middle name | |
| Last name | Mitsuyoshi |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Radiation Oncology
Zip code
650-0047
Address
2-1-1 Minatojima Minamimachi, Chuo-ku, Kobe
TEL
078-302-4321
Homepage URL
mitsu.t@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kobe City Hospital Organization, Kobe City Medical Center General Hospital (Clinical Departments I, II, and III)
Institute
Department
Personal name
Funding Source
Organization
Kobe City Hospital Organization, Kobe City Medical Center General Hospital (Clinical Departments I, II, and III)
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
Clinical Research Office, Kobe City Medical Center General Hospital
Address
2-1-1 Minatojima Minamimachi, Chuo-ku, Kobe
Tel
078-302-4499
rinken@kcho.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
神戸市立医療センター中央市民病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2033 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2033 | Year | 05 | Month | 30 | Day |
Date trial data considered complete
| 2033 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2034 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 24 | Day |
Last modified on
| 2026 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069708
