Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06561555
PHASE2

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

Sponsor: Fudan University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2024-08-15

Completion Date

2027-08-15

Last Updated

2024-12-17

Healthy Volunteers

No

Interventions

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.

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China