A phase 3 trial testing ESG401 in HR-positive / HER2-negative breast cancer, now recruiting.
A Phase III Study of ESG401 for Locally Advanced or Metastatic HR+/HER2- Breast Cancer is a phase 3 interventional study registered as NCT06383767, led by Qilu Pharmaceutical, and recruiting on the registry. Official title: A Open-label, Randomised, Multicenter Phase III Study of ESG401 Versus Investigator's Choice Chemotherapy in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer Who Had Failed at Least One Line of Chemotherapy. Planned enrolment is 378 participants (estimated). The study started in 2024-07-11 and primary completion is expected in 2027-06-30. No results have been posted on ClinicalTrials.gov.