HR Positive, HER2 Negative Advanced Breast Cancer With Progression After Endocrine Therapy
Status:
Not yet recruiting
Trial end date:
2025-05-01
Target enrollment:
Participant gender:
Summary
Primary objective:
To evaluate the progression-free survival (PFS) for EOC202 combined with albumin-bound
paclitaxel versus albumin-bound paclitaxel alone in treatment of the patients with HR
positive, HER2 negative advanced breast cancer (response evaluation criteria in solid tumors,
RECIST 1.1);
Secondary objectives:
1. To evaluate other efficacy variables, such as objective response rate (ORR), disease
control rate (DCR), clinical benefit rate (CBR) and overall survival (OS), for EOC202
combined with albumin-bound paclitaxel versus albumin-bound paclitaxel alone in
treatment of HR positive, HER2 negative advanced breast cancer;
2. To evaluate the safety of EOC202 combined with albumin-bound paclitaxel;
3. To evaluate the immunogenicity of EOC202 combined with albumin-bound paclitaxel;
4. To evaluate the change level of pharmacodynamic (PD) markers (Interferon-γ, CXCL-10).
Exploratory objectives:
To explore the correlation of baseline soluble MHC-II ligands in blood (lymphocyte activation
gene-3 (Lag-3) and fibrin related antigen (FGL-1)) with safety, efficacy, PD and anti-drug
antibody (ADA) in subjects in EOC202 combined with albumin-bound paclitaxel group.