drugset / Trial / NCT06561555

A Study on the Efficacy of Disitamab Vedotin in Advanced HER2-positive Paget's Disease.

NCT06561555

Phase 2 Recruiting 36 enrolled Fudan University
NaSingle-groupOpen-labelTreatment

Summary

This study is a single-center, phase II clinical trial. Patients with HER2-positive advanced breast and extramammary Paget's disease who met the eligibility criteria were enrolled after signing an informed consent form. All patients received treatment with 2mg/kg of trastuzumab deruxtecan intravenous infusion every 3 weeks until disease progression. Follow-up was conducted until disease progression, withdrawal of informed consent by the subject, loss to follow-up, or death. Clinical tumor imaging assessments were performed using RECIST during the treatment process.

Timeline

Start
2024-08-15
Primary completion
2025-08-15
Completion
2027-08-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Disitamab Vedotin Monoclonal antibody 2 mg/kg Intravenous

Indications