Tokyo, Oct. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063303) titled 'Prospective observational study of eye problems associated with Datopotamab deruxtecan treatment (WJOG21625B)' on Oct. 16.
Study Type:
Observational
Primary Sponsor:
Institute - West Japan Oncology Group
Condition:
Condition - Breast Cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the incidence and severity of Datopotamab deruxtecan related ocular adverse events
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
=18 years at the time of informed consent.
4) No prior treatment with Dato-DXd.
5) Planned initiation of Dato-DXd treatment within 28 days after enrollment.
6) Able to complete electronic patient-reported outcome (ePRO) assessments.
7) Provided written informed consent prior to study enrollment after receiving a full explanation of the study.
Key exclusion criteria - 1) History of hypersensitivity to any component of Dato-DXd.
2) Clinically significant corneal disease.
3) Any condition that, in the investigator's judgment, makes the patient unsuitable for study participation.
Target Size - 150
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 04 Month 28 Day
Date of IRB - 2026 Year 09 Month 01 Day
Anticipated trial start date - 2026 Year 11 Month 09 Day
Last follow-up date - 2028 Year 05 Month 09 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070703
Disclaimer: Curated by HT Syndication.
