Tokyo, Dec. 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060135) titled 'Effect of early intervention using continuous glucose monitoring (CGM; FreeStyle Libre 2) for prevention of hyperglycemic adverse events in patients receiving capivasertib' on Dec. 22.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Kyoto Prefectural University of Medicine
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 malignancy - Malignancy
Genomic information - NO
Objective:
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
Intervention:
Interventions/Control_1 - Application of the FreeStyle Libre 2 sensor
Eligibility:
Age-lower limit - 20
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 Size - 20
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2024 Year 12 Month 22 Day
Anticipated trial start date - 2025 Year 12 Month 22 Day
Last follow-up date - 2030 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068721
Disclaimer: Curated by HT Syndication.
