Tokyo, July 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062323) titled 'A Prospective Study of Early Intervention and Risk Factors for Hyperglycemic Adverse Events in Patients Receiving Capivasertib' on July 27.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Osaka Red Cross Hospital
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 malignancy - Malignancy
Genomic information - NO
Objective:
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
Intervention:
Interventions/Control_1 - Application of the Dexcom G7 sensor
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 Size - 20
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 03 Month 23 Day
Anticipated trial start date - 2026 Year 04 Month 01 Day
Last follow-up date - 2029 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069725
Disclaimer: Curated by HT Syndication.
