UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060135 |
|---|---|
| Receipt number | R000068721 |
| Scientific Title | A Prospective Study of Early Intervention Using Continuous Glucose Monitoring to Prevent Hyperglycemic Adverse Events in Patients Receiving Capivasertib |
| Date of disclosure of the study information | 2025/12/22 |
| Last modified on | 2025/12/19 15:26:24 |
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Basic information
Public title
Effect of early intervention using continuous glucose monitoring (CGM; FreeStyle Libre 2) for prevention of hyperglycemic adverse events in patients receiving capivasertib
Acronym
Prevention of capivasertib-associated hyperglycemia
Scientific Title
A Prospective Study of Early Intervention Using Continuous Glucose Monitoring to Prevent Hyperglycemic Adverse Events in Patients Receiving Capivasertib
Scientific Title:Acronym
Prevention of capivasertib-associated hyperglycemia
Region
| Japan |
Condition
Condition
Hormone receptor positive, HER2 negative unresectable or recurrent breast cancer with PIK3CA, AKT1, or PTEN gene mutations that has progressed after endocrine therapy
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to visualize the occurrence of capivasertib-associated hyperglycemia using continuous glucose monitoring (CGM) with the FreeStyle Libre 2 and to establish an early-intervention approach based on CGM data and/or outpatient laboratory findings to prevent severe hyperglycemia.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hyperglycemic events detected by FreeStyle Libre 2 data
Key secondary outcomes
Additional FreeStyle Libre 2 data, including mean sensor glucose, standard deviation, GMI, coefficient of variation, TIR, TBR (levels 1 and 2), TAR (levels 1 and 2), alert frequency, blood glucose levels, and HbA1c.
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 FreeStyle Libre 2 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
| 90 | years-old | > |
Gender
Female
Key inclusion criteria
Outpatients eligible for treatment with capivasertib
Patients who are able to provide written informed consent of their own will
Patients aged over 20 and less than 90 years at the time of consent
female
Key exclusion criteria
Patients deemed inappropriate for participation by the attending physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Michiaki |
| Middle name | |
| Last name | Fukui |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Endocrinology and Metabolism, Graduate School of Medical Science
Zip code
602-8566
Address
465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
TEL
075-251-5505
michiaki@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Hanako |
| Middle name | |
| Last name | Nakajima |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Endocrinology and Metabolism, Graduate School of Medical Science
Zip code
602-8566
Address
465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
TEL
075-251-5506
Homepage URL
tabahana@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Nakajima
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
Secretariat of the Review Committee, Kyoto Prefectural University of Medicine
Address
465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
Tel
075-251-5337
rinri@koto.kpu-m.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
京都府
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 22 | 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
| 2024 | Year | 12 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 22 | Day |
Last follow-up date
| 2030 | Year | 03 | 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
| 2025 | Year | 12 | Month | 19 | Day |
Last modified on
| 2025 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068721
