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Dalpicilib-Enhanced vs. Standard Endocrine Therapy in ER+ HER2- Early Breast Cancer

StatusRecruiting
PhasePhase 3
Started2025-01-09
View on ClinicalTrials.gov ↗

Amendment history

2026-09-30
notable
Enrollment reopened
624 trials monitored
See 9 trials at risk
5,180 trials monitored
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This study aims to conduct a randomized controlled clinical trial to compare the efficacy and safety of dalpicilib combined with endocrine therapy versus standard endocrine therapy in ER-positive, HER2-negative, lymph node-negative patients with risk factors, in order to further optimize the regimen for adjuvant endocrine therapy in breast cancer.
Trial Details
NCT Number NCT06637150
Lead Sponsor Fudan University
Conditions Breast Cancer
Enrollment 1,388 participants
Start Date 2025-01-09
Primary Completion 2030-09-30 (estimated)
Study Completion 2030-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-29