Overview

Cohort Study on Sequential ADC Therapy in HR-positive/HER2-negative Advanced Breast Cancer

Status:
NOT_YET_RECRUITING
Trial end date:
2027-12-31
Target enrollment:
Participant gender:
Summary
The combination of cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) and endocrine therapy is the standard first-line treatment for advanced HR+ (hormone receptor-positive)/HER2- (human epidermal growth factor receptor 2-negative) breast cancer. However, the optimal treatment strategy after CDK4/6i progression remains unclear. In recent years, antibody-drug conjugates (ADCs) such as sacituzumab govitecan (SG) and trastuzumab deruxtecan (T-DXd) have demonstrated significant activity in HR+/HER2- breast cancer, providing new options post-CDK4/6i progression. Yet, the optimal sequencing of different ADCs (e.g., SG followed by T-DXd vs. T-DXd followed by SG) after CDK4/6i failure remains uncertain. Determining how to further optimize treatment selection to prolong survival and improve quality of life has become a key research focus in clinical practice. This study aims to explore the efficacy, safety, and potential resistance mechanisms of biomarker-guided sequential ADC therapy (e.g., SGT-DXd vs. T-DXdSG) following CDK4/6i progression. The findings may guide clinical decision-making and provide evidence for precision medicine.
Phase:
PHASE4
Details
Lead Sponsor:
Yan Xue