Clinical Trial

Efficacy and Safety of Pyrotinib Maleate Combined With ARX788 Neoadjuvant Treatment in Breast Cancer Patients

Recruiting Phase 2
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Summary
Next-generation Site-specific human epidermal growth factor receptor 2 (HER2)-targeting Antibody-drug Conjugate (ARX788) is an antibody-conjugated drug. Results from the phase I safety, tolerability and pharmacokinetic trial of ARX788 single drug in Chinese patients with advanced HER2 breast cancer indicated a good safety of the test drug, and responses to anti-tumor therapy were observed in the target dose group. Phase II clinical trial is being carried out gradually. This trial is designed to observe the effectiveness and safety of pyrotinib maleate combined with ARX788 neoadjuvant treatment in stage II-III HER2-positive breast cancer patients experiencing a poor efficacy of trastuzumab and pertuzumab.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2021-07-27; most recent amendment 2022-09-12.
Status change: Not Yet Recruiting → Recruiting 2022-07-30
Trial Details
NCT Number NCT04983121
Lead Sponsor Shengjing Hospital
Conditions Breast Neoplasms
Enrollment 30 participants
Start Date 2021-08-01
Primary Completion 2027-08-15 (estimated)
Study Completion 2027-08-15 (estimated)
Updated on ClinicalTrials.gov 2022-09-13