RecruitingPhase 2NCT06561555

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.

Sponsor

Fudan University

Enrollment

36 participants

Start Date

Aug 15, 2024

Study Type

INTERVENTIONAL

Conditions

Mammary or Extramammary Paget's Disease

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called disitamab vedotin in patients with advanced HER2-positive Paget's disease — a rare skin cancer affecting the breast or other areas — to see how well it works and how safe it is. **You may be eligible if...** - You are 18 or older with confirmed Paget's disease that tests positive for HER2 - Your cancer is advanced and has at least one measurable lesion on imaging - Your organ function (blood counts, liver, kidneys) is within acceptable ranges - Your expected survival is at least 3 months **You may NOT be eligible if...** - You have a history of immune deficiency, HIV, or organ transplant - You have had an active autoimmune disease in the past 2 years - You have active tuberculosis or serious uncontrolled infections - You have significant bleeding problems or are on blood-thinning therapy - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRC48

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

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NCT06561555