UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062323 |
|---|---|
| Receipt number | R000069725 |
| Scientific Title | A Prospective Study of Early Intervention and Risk Factors for Hyperglycemic Adverse Events in Patients Receiving Capivasertib. |
| Date of disclosure of the study information | 2026/07/27 |
| Last modified on | 2026/07/23 20:20:14 |
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Basic information
Public title
A Prospective Study of Early Intervention and Risk Factors for Hyperglycemic Adverse Events in Patients Receiving Capivasertib.
Acronym
A Prospective Study of Early Intervention and Risk Factors for Hyperglycemic Adverse Events in Patients Receiving Capivasertib.
Scientific Title
A Prospective Study of Early Intervention and Risk Factors for Hyperglycemic Adverse Events in Patients Receiving Capivasertib.
Scientific Title:Acronym
A Prospective Study of Early Intervention and Risk Factors for Hyperglycemic Adverse Events in Patients Receiving Capivasertib.
Region
| Japan |
Condition
Condition
Unresectable or recurrent hormone receptor-positive, HER2-negative breast cancer with PIK3CA/AKT1/PTEN gene mutations that progressed after endocrine therapy
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
PIK3CA/AKT1/PTEN constitute one of the key pathways in insulin receptor signaling. In fact, hyperglycemic adverse events have been reported after the use of capivasertib even in patients without diabetes. In this study, to evaluate the risk and frequency of hyperglycemia, glycemic fluctuations associated with capivasertib administration will be assessed using continuous glucose monitoring (CGM). The timing of hyperglycemia onset will be investigated, and appropriate management strategies for hyperglycemia will be explored.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence of hyperglycemia based on CGM data
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Application of the Dexcom G7 sensor
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
Male and Female
Key inclusion criteria
Patients aged 20 years or older who will receive capivasertib and are able to provide written informed consent for participation in this study
Key exclusion criteria
Patients who are deemed inappropriate for study participation by the principal investigator or sub-investigators
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Seiji |
| Middle name | |
| Last name | Muro |
Organization
Osaka Red Cross Hospital
Division name
Department of Diabetes and Endocrinology
Zip code
5438555
Address
5-30, Fudegasakicho, Tennouji-ku, Osaka-shi
TEL
0667745111
muro@osaka-med.jrc.or.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Fushimi |
Organization
Osaka Red Cross Hospital
Division name
Department of Diabetes and Endocrinology
Zip code
5438555
Address
5-30, Fudegasakicho, Tennouji-ku, Osaka-shi
TEL
0667745111
Homepage URL
t-fushimi.bp@osaka-med.jrc.or.jp
Sponsor or person
Institute
Osaka Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Red Cross Hospital Medical Ethics Committee
Address
5-30, Fudegasakicho, Tennouji-ku, Osaka-shi
Tel
0667745111
soumudaiichi@osaka-med.jrc.or.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
| 2026 | Year | 07 | Month | 27 | 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 | 03 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 23 | Day |
Last modified on
| 2026 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069725
