NCT07467330

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

Open, Randomized Controlled Study of Dalpiciclib Combined With Endocrine Therapy and Metronomic Capecitabine Versus Dalpiciclib Combined With Endocrine Therapy for HR +/HER2- Recurrent Metastatic Breast Cancer With Visceral Metastasis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 258 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	dalpiciclib + capecitabine + endocrine therapy	The experimental arm received dalpiciclib combined with endocrine therapy and metronomic capecitabine chemotherapy
DRUG	dalpiciclib + endocrine therapy	Control group received dalpiciclib combined with endocrine therapy

Timeline

• Start date: 2025-11-15
• Primary completion: 2031-12-31
• Completion: 2032-12-31
• First posted: 2026-03-12
• Last updated: 2026-03-12

Locations

1 site across 1 country: China