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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date changed from estimate of Jul 31, 2022 to Aug 1, 2021v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Aug 10, 2021 to Jul 31, 2022
    • Site details revised
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04983121
Lead Sponsor Shengjing Hospital
Conditions
(from sponsor)		 Breast Neoplasms
Related terms Breast Neoplasms
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov