Phase 3 Study Comparing ESG401 and Physicians Choice Chemotherapy for Adults with Advanced HRHER2- Breast Cancer After Chemotherapy Failure

What this Trial Is About

Researchers are evaluating the safety and effectiveness of ESG401 in patients with unresectable locally advanced or metastatic HRHER2- breast cancer who have previously undergone at least one line of systemic chemotherapy. This Phase 3 open-label, randomized, multicenter study compares ESG401 to treatments chosen by physicians to determine which approach may better manage this type of breast cancer. Participants will receive ESG401 as an intravenous infusion on days 1, 8, and 15 of each 28-day cycle. The comparison group will receive one of several chemotherapy options including eribulin, capecitabine, vinorelbine, or gemcitabine, given on schedules ranging from 21 to 28-day cycles. The study is designed to monitor and compare responses over time while patients undergo these treatments. During the study, participants will be closely monitored through various assessments including imaging scans to measure tumor progression, survival rates, response rates, and quality of life evaluations using the NCC-BC-A scale. Safety will be tracked by documenting any adverse events up to 30 days after the last dose. The main outcome measured is progression-free survival for up to 24 months, with additional follow-up to assess overall survival and other clinical responses. Participants organ and bone marrow functions will also be evaluated regularly to ensure safety throughout the study period.

A Phase III Study of ESG401 for Locally Advanced or Metastatic HR+/HER2- Breast Cancer