Double-blind, Randomized, Multicenter, Phase III Clinical Study to Compare the Efficacy and to Evaluate the Safety and Immunogenicity of Trastuzumab Biosimilar HLX02 and EU-sourced Herceptin in Previously Untreated HER2 Overexpressing Metastatic Breast Cancer
Latest Information Update: 03 May 2024
At a glance
- Drugs Trastuzumab (Primary) ; Docetaxel
- Indications Adenocarcinoma; Advanced breast cancer; HER2 positive breast cancer
- Focus Registrational; Therapeutic Use
- Sponsors Shanghai Henlius Biotech
- 29 Apr 2024 According to an Accord Biopharma media release, the U.S. Food and Drug Administration (FDA) has approved HERCESSI™ (trastuzumab-strf), a biosimilar to Herceptin (trastuzumab), to treat HER2-overexpressing breast and gastric or gastroesophageal junction adenocarcinomabased on this trial.
- 15 Feb 2023 According to a Shanghai Henlius Biotech media release, company announced, acceptance of Biologics License Application from US FDA for proposed biosimilar trastuzumab HLX02, based on clinical data of this trial.
- 01 Jun 2022 Status changed from active, no longer recruiting to completed.