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A randomized, open-label, controlled, multicenter phase III clinical trial of A166 for injection versus trastuzumab emtansine for injection (T-DM1) in patients with HER2-positive unresectable or metastatic breast cancer who had previously received trastuzumab and taxane treatment

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A randomized, open-label, controlled, multicenter phase III clinical trial of A166 for injection versus trastuzumab emtansine for injection (T-DM1) in patients with HER2-positive unresectable or metastatic breast cancer who had previously received trastuzumab and taxane treatment

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 09 Apr 2025

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At a glance

  • Drugs Trastuzumab botidotin (Primary) ; Trastuzumab emtansine
  • Indications Advanced breast cancer; HER2 positive breast cancer; Male breast cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Sichuan Kelun Botai Biological Medicine

    • Most Recent Events

    • 09 Apr 2025 New trial record
    • 07 Apr 2025 Primary endpoint has been met. (PFS (progression-free survival) assessed by BICR using RECIST 1.1), according to a Sichuan Kelun-Biotech Biopharmaceutical media release.
    • 07 Apr 2025 According to a Sichuan Kelun-Biotech Biopharmaceutical media release, at a pre-specified interim analysis, trastuzumab botidotin monotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) as assessed by the blinded independent central review (BICR) compared with T-DM.

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