Clinical Trial

Dalpiciclib Combined With Endocrine Therapy and Metronomic Capecitabine vs Dalpiciclib Combined With Endocrine Therapy for First-line Treatment

Recruiting Phase 3
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Summary
This study is an open-label, multicenter, randomized controlled study. It is planned to include 258 patients with HR +/HER2- advanced breast cancer with visceral metastases. Eligible subjects will be randomized 1:1 to receive dalpiciclib in combination with endocrine therapy and metronomic capecitabine chemotherapy in the experimental arm and dalpiciclib in combination with endocrine therapy in the control arm. Randomization was stratified by the number of lines of therapy for recurrent metastases (0 versus 1) and endocrine therapy (AI versus fulvestrant).
Trial Details
NCT Number NCT07467330
Lead Sponsor Fujian Cancer Hospital
Conditions Breast Cancer
Enrollment 258 participants
Start Date 2025-11-15
Primary Completion 2031-12-31 (estimated)
Study Completion 2032-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-12