Clinical Trial

Optimal Application Timing of ADC Drugs for Advanced Breast Cancer

Recruiting Phase 2
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Record status
This record was last updated June 18, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT07657130
Lead Sponsor Liaoning Cancer Hospital & Institute
Collaborators: National Cancer Center, China
Conditions Breast Cancer Females
Enrollment 120 participants
Start Date 2025-07-01
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-18