NCT06561555

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mammary or Extramammary Paget's Disease

Interventions

Type	Name	Description
DRUG	RC48	RC48 at a dosage of 2mg/kg administered intravenously every 3 weeks (ivgtt q3w) is continued until disease progression, with the allowance for treatment discontinuation due to disease progression, death, intolerable toxicity, withdrawal of informed consent, initiation of new antineoplastic therapy, or other reasons specified in the protocol, with the earliest occurring event taking precedence. Alternatively, the study investigator may determine the need to discontinue treatment.

Timeline

• Start date: 2024-08-15
• Primary completion: 2025-08-15
• Completion: 2027-08-15
• First posted: 2024-08-20
• Last updated: 2024-12-17

Locations

1 site across 1 country: China