Actively Recruiting
A Study on the Efficacy of Disitamab Vedotin in Advanced HER2-positive Paget's Disease.
Led by Fudan University · Updated on 2024-12-17
36
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study on the Efficacy of Disitamab Vedotin in Advanced HER2-positive Paget's Disease.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the informed consent form and comply with the study requirements.
- Age 18 years or older.
- Confirmed diagnosis of mammary or extramammary Paget's disease with HER2 positivity by pathological testing.
- ECOG performance status score of 0 to 1.
- At least one measurable lesion by RECIST criteria or evaluable skin lesions by WHO criteria.
- Adequate blood, liver, renal, and coagulation function as specified.
- Estimated life expectancy of at least 3 months.
You will not qualify if you...
- History of immunodeficiency including HIV or organ transplantation.
- Active autoimmune diseases within 2 years requiring systemic treatment, or current high-dose immunosuppressive therapy.
- History of active tuberculosis.
- Uncontrolled recurrent ascites, pericardial effusion, or pleural effusion.
- Major organ transplantation.
- Major surgery, biopsy, or significant injury within 28 days before treatment start.
- Chronic non-healing wounds or fractures.
- Live attenuated vaccine administration within 14 days prior or planned during study.
- Severe hypersensitivity to monoclonal antibodies or study drug components.
- Participation in other clinical trials within 4 weeks before study start.
- History of severe allergies.
- Risk of bleeding, coagulation disorders, or current thrombolytic therapy.
- Substance abuse or mental disorders affecting study compliance.
- Any other conditions judged by the investigator to endanger safety or study completion.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
W
wang hongxia, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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