Efficacy and Safety of Dalpiciclib in Hormone Receptor-positive Advanced Breast Cancer
NCT05578053 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 420
Last updated 2025-09-11
Summary
This study is a multi-center, observational, real-world study. We planned to recruit 420 HR+ locally advanced or metastatic breast cancer patients who had received or had not received prior systemic therapy. All patients included in the analysis were receiving or planning to receive dalpiciclib-containing regimens without restrictions, completely following the physician 's clinical choice, to assess the efficacy and safety of dalpiciclib-containing regimens.
Conditions
Interventions
- DRUG
-
Dalpiciclib
a new, orally administered, selective CDK4/6 inhibitor
Sponsors & Collaborators
-
Hebei Medical University Fourth Hospital
lead OTHER
Principal Investigators
-
Cuizhi Geng Cuizhi Geng, archiater · Hebei Medical University Fourth Hospital
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-13
- Primary Completion
- 2028-12-01
- Completion
- 2030-12-01
Countries
- China
Study Locations
More Related Trials
-
Exploration of Dalpiciclib Plus HDACi in HR+/HER2- Advanced Breast Cancer After Failure of CDK4/6 Inhibitor
NCT06556862 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
The Efficacy and Safety of Dalpiciclib Plus Endocrine Therapy in HR-positive / HER2-negative Advanced Breast Cancer Patients With Visceral Crisis
NCT05431504 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Dalpiciclib Plus Letrozole and Capecitabine
NCT05469750 ·Status: UNKNOWN ·Phase: PHASE2
-
Dalpiciclib Plus AI (Neoadjuvant Endocrine Therapy) Compared With Neoadjuvant Chemotherapy in Early Breast Cancer (EBC)
NCT06107673 ·Status: RECRUITING ·Phase: PHASE2
-
Dalpiciclib Plus Fulvestrant With Pyrotinib in Hormone Receptor-positive, HER2-low Advanced Breast Cancer That Progressed on Previous CDK4/6i Plus AI Therapy
NCT05806671 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Efficacy and Safety of Dalpiciclib Plus Toremifene in the Treatment of Advanced First-line HR Positive and HER2 Negative Breast Cancer: a Multicenter, Single Arm, Exploratory Phase II Clinical Study
NCT06495515 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Dalpiciclib With Endocrine Therapy for Advanced Breast Cancer After CDK4/6 Inhibitor Failure (DAWNA-FES)
NCT05861830 ·Status: RECRUITING ·Phase: PHASE3
-
Abemaciclib, Palbociclib or Dalpiciclib Combined with Endocrine Therapy As First-line Treatment in HR Positive, HER2 Negative Unresectable or Metastatic Breast Cancer
NCT06344780 ·Status: ACTIVE_NOT_RECRUITING
-
Efficacy and Safety of Trastuzumab Rezetecan Followed by CDK4/6 Inhibitors and Endocrine Therapy in HR+/HER2-Low/Ultra-Low Advanced Breast Cancer
NCT07037199 ·Status: RECRUITING ·Phase: PHASE2
-
PARP Inhibitor With CDK4/6 Inhibitor and Endocrine Therapy in HR+/ HER2-Advanced Breast Cancer
NCT05759546 ·Status: RECRUITING ·Phase: PHASE2
-
Adebrelimab Combined With Dalpiciclib and Standard Endocrine Therapy for HR+/HER2 - Advanced Breast Cancer
NCT06149130 ·Status: RECRUITING ·Phase: PHASE2
-
Different Doses of Dalpicicl Combined With Letrozole in the First-line Treatment of HR-positive, HER2-negative Advanced Breast Cancer
NCT07285382 ·Status: RECRUITING ·Phase: PHASE2
-
A Trial of HRS-1358 Tablets in Metastatic or Local Advanced Breast Cancer
NCT05628870 ·Status: RECRUITING ·Phase: PHASE1
-
Dalpicilib-Enhanced Vs. Standard Endocrine Therapy in ER+ HER2- Early Breast Cancer
NCT06637150 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Apatinib With CDK4/6 Inhibitor and Endocrine Therapy in HR+/ HER2- Advanced Breast Cancer
NCT05759572 ·Status: RECRUITING ·Phase: PHASE2
-
Treatment of Dalpiciclib Combined With Pyrotinib for Trastuzumab-sensitive HER2+ Advanced Breast Cancer(DAP-Her-02)
NCT05328440 ·Status: RECRUITING ·Phase: PHASE2
-
An Open-Label, Bayesian Adaptive Phase II Clinical Study in HR+/HER2- Advanced Breast Cancer After Progression on Standard Therapy
NCT07117630 ·Status: RECRUITING ·Phase: PHASE2
-
An Exploratory Clinical Study of CDK4/6i Dalpiciclib Combined With AI Neoadjuvant Therapy for Stage II-III HR+/HER2- Breast Cancer
NCT06613373 ·Status: NOT_YET_RECRUITING ·Phase: PHASE4
-
Dalpiciclib, Fulvestrant, Trastuzumab and Pertuzumab in HR Positive, HER2 Positive Metastatic Breast Cancer
NCT05574881 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Adebrelimab Combined With Dalpiciclib and Standard Endocrine Therapy for HR + / HER2- Breast Cancer
NCT06599216 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
The Efficacy and Safety of CDK4/6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment
NCT06810492 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
A Study of Ribociclib in Combination With Hormonal Therapy in HR+/HER2- Advanced or Metastatic Breast Cancer
NCT06075758 ·Status: COMPLETED
-
Dalpiciclib in Combination With Exemestane and Trastuzumab Plus Pyrotinib in Early Triple Positive Breast Cancer
NCT04997798 ·Status: UNKNOWN ·Phase: PHASE2
-
CDK4/6 Inhibitors in Patients With Hormone Receptor-positive Advanced Breast Cancer
NCT05795335 ·Status: RECRUITING
-
A Study of HS-10342 in Chinese Patients With HR+/HER2- Advanced and/or Metastatic Breast Cancer
NCT05044988 ·Status: UNKNOWN ·Phase: PHASE2