Optimal Application Timing of ADC Drugs for Advanced Breast Cancer
Summary
This study plans to initiate a prospective, randomized controlled trial to investigate the optimal timing of antibody drug conjugate (ADC) therapy in the management of advanced Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer. Primary Objective: To compare the difference in PFS2 (Time from randomization to disease progression after second therapy) between antibody-drug conjugate (ADC) followed by chemotherapy versus chemotherapy followed by ADC in the treatment of advanced HER2-negative breast cancer. Secondary Objectives: To compare overall survival (OS), adverse events, patient-reported outcomes, and cost-effectiveness between the two treatment sequences. Additionally, to identify potential biomarkers predictive of benefit from frontline ADC therapy.
Timeline
- Start
- 2025-07-01
- Primary completion
- 2026-06-30
- Completion
- 2026-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | — | — |
| Subject | Eribulin | Small molecule | — | — |
| Subject | Gemcitabine | Small molecule | — | — |
| Subject | Sacituzumab Govitecan | Monoclonal antibody | — | — |
| Subject | Trastuzumab deruxtecan | Monoclonal antibody | — | — |
| Subject | Vinorelbine | Small molecule | — | — |