Tokyo, Oct. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059286) titled 'Pharmacokinetics/pharmacodynamics/genome pharmacology study of the antibody-drug conjugate Sacituzumab Govitecan: multi-institutional prospective observational trial' on Oct. 4.
Study Type:
Observational
Primary Sponsor:
Institute - Keio University
Condition:
Condition - Triple Negative Breast Cancer (TNBC)
Classification by malignancy - Malignancy
Genomic information - YES
Objective:
Narrative objectives1 - To investigate whether there are differences in the incidence of adverse events and drug blood concentrations between patients with unresectable or recurrent triple-negative breast cancer who received Sacituzumab Govitecan therapy and those with UGT1A1 gene polymorphisms compared to those with wild-type genotypes.
Basic objectives2 - PK,PD
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Patients diagnosed with inoperable or recurrent TNBC.
2. Patients aged 18 years or older scheduled to undergo SG therapy.
3. Patients who have provided written informed consent.
Key exclusion criteria - 1. Patients who are pregnant or may be pregnant
2. Patients taking UGT1A1-inducing drugs (carbamazepine, phenytoin, rifampicin, phenobarbital)
3. Patients who have withdrawn their consent
4. Other cases deemed unsuitable by the physician
Target Size - 100
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 07 Month 23 Day
Date of IRB - 2025 Year 09 Month 29 Day
Anticipated trial start date - 2026 Year 01 Month 01 Day
Last follow-up date - 2027 Year 04 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067441
Disclaimer: Curated by HT Syndication.
