Phase 2 JSKN003 Versus Trastuzumab for HER2+ Recurrent/Metastatic Breast Cancer

NIH registered a new Phase 2 randomized controlled trial on ClinicalTrials.gov (NCT07545044), filed April 22, 2026, evaluating JSKN003 as a first-line treatment for HER2-positive recurrent or metastatic breast cancer. The open-label multicenter superiority trial compares JSKN003 head-to-head against trastuzumab in combination with pertuzumab and docetaxel, with approximately 400 participants targeted for enrollment. Eligibility includes patients with no prior systemic therapy for advanced disease, though one prior endocrine treatment regimen is permitted.

For pharmaceutical sponsors, clinical investigators, and CROs, this trial registration signals an active Phase 2 development program for a HER2-targeting agent in a competitive breast cancer indication. Sites with oncology trial infrastructure should monitor recruitment status and protocol requirements for potential participation. The trial's randomized controlled design and superiority endpoint framework are standard for confirmatory Phase 2 oncology studies.