Tokyo, Feb. 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060694) titled 'Prospective evaluation of a biomarker for abemaciclib-induced hepatotoxicity (confirmatory study)' on Feb. 17.
Study Type:
Observational
Primary Sponsor:
Institute - Saitama Cancer Center
Condition:
Condition - Breast Cancer
Classification by malignancy - Malignancy
Genomic information - YES
Objective:
Narrative objectives1 - To evaluate an identified HLA allele as a biomarker for abemaciclib-induced hepatotoxicity.
Basic objectives2 - Pharmacodynamics
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Female
Key inclusion criteria - Breast cancer patients starting to treat with abemaciclib at 300 mg/day within two weeks.
Key exclusion criteria - None
Target Size - 150
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2026 Year 01 Month 15 Day
Date of IRB - 2026 Year 01 Month 20 Day
Anticipated trial start date - 2026 Year 02 Month 12 Day
Last follow-up date - 2029 Year 02 Month 11 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069366
Disclaimer: Curated by HT Syndication.
