22 recruiting, 15 not yet recruiting, 15 unknown, 3 active not recruiting. 42 Phase 2, 8 Phase 1, 5 Phase 3, 4 Not applicable, 1 Phase 4.
Follow dalpiciclib: new trials by email Literature Review of dalpiciclib trials Research Report on dalpiciclib
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Trastuzumab Rezetecan Followed by Pyrotinib, Fulvestrant, and Dalpiciclib in HR-Positive, HER2-Positive Advanced Breast Cancer Fulvestrant, Pyrotinib, Dalpiciclib - Metastatic Breast Cancer (MBC), HER2-Positive Breast Cancer | Phase 3 | Not yet recruiting | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | 226 | 2026-11-01 | 2026-10-23 |
| Tolerability of Dalpiciclib vs. Abemaciclib/Ribociclib in Early HR+/HER2- Breast Cancer Dalpiciclib, Abemaciclib/Ribociclib - Breast Cancer | Not applicable | Not yet recruiting | Henan Cancer Hospital | 456 | 2026-11-01 | 2026-10-27 |
| Abiraterone With Dalpiciclib in Salivary Gland Carcinoma abiraterone combined with dalpiciclib - Salivary Gland Carcinoma | Phase 2 | Recruiting | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | 36 | 2026-10-01 | 2026-09-11 |
| IN10018 in Combination With Dalpiciclib for Progressive Meningiomas Ifebemtinib, Dalpiciclib - Meningioma, CDK4/6 Inhibitor | Phase 1 | Recruiting | Capital Medical University | 24 | 2026-08-31 | 2026-10-21 |
| Precision Medicine for Immunotherapy-Resistant Advanced Esophageal Cancer Afatinib + Toripalimab, Dalpiciclib + Pyrotinib, Camrelizumab + Apatinib - Esophageal Squamous Cell Carcinoma | Phase 2 / Phase 3 | Not yet recruiting | Peking University Cancer Hospital & Institute | 90 | 2026-07-01 | 2026-06-17 |
| Dalpiciclib, Anti-HER2 Therapy, and Endocrine Therapy for Hormone-Receptor-Positive, HER2-Positive Metastatic Breast Cancer Dalpiciclib, Trastuzumab (Herceptin), Pertuzumab - Advanced/Metastatic Breast Cancer, HER2-Positive Metastatic Breast Cancer | Phase 2 | Recruiting | Sun Yat-sen University | 57 | 2026-06-01 | 2026-05-28 |
| Neoadjuvant Dalpiciclib + AI → SHR-A1811 for HR+/HER2-Low Breast Cancer Dalpiciclib 125mg, Aromatase Inhibitor, SHR-A1811 - Breast Cancer, HR Positive/HER2 Low Breast Cancer | Phase 2 | Not yet recruiting | Tang-Du Hospital | 20 | 2026-06-01 | 2026-06-11 |
| Brain Radiotherapy Combined With Dalpiciclib and Endocrine Therapy in HR-Positive/HER2-Negative Advanced Breast Cancer With Brain Metastases Dalpiciclib, Endocrine Therapy of Physician's Choice, Brain Radiotherapy - Breast Cancer, Brain Metastases | Phase 2 | Not yet recruiting | Nanfang Hospital, Southern Medical University | 46 | 2026-06-01 | 2026-04-30 |
| Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy for Early HR +/HER2- Breast Cancer: a Multicenter, Prospective Clinical Study Dalpiciclib 125mg, Dalpiciclib 100mg, Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifen - Breast Diseases, Breast Neoplasms | Phase 2 | Recruiting | Fujian Cancer Hospital | 2000 | 2026-01-21 | 2026-05-12 |
| SHR-A1811 Plus Pertuzumab as Neoadjuvant Therapy for Early or Locally Advanced HR-Positive HER2-Positive Breast Cancer: A Prospective, Open-Label, Phase II Study SHR- A1811 - SHR-A1811, HER2-Postive Breast Cancer | Phase 2 | Not yet recruiting | Tianjin Medical University Cancer Institute and Hospital | 30 | 2025-12-20 | 2025-12-29 |
| Dalpiciclib Combined With Endocrine Therapy and Metronomic Capecitabine vs Dalpiciclib Combined With Endocrine Therapy for First-line Treatment dalpiciclib + capecitabine + endocrine therapy, dalpiciclib + endocrine therapy - Breast Cancer | Phase 3 | Recruiting | Fujian Cancer Hospital | 258 | 2025-11-15 | 2026-03-12 |
| A Randomised, Open-label, Multicentre Phase III Clinical Study to Evaluate the Efficacy and Safety of JS105 Combined With Dalpiciclib and Fulvestrant Compared With Dalpiciclib and Fulvestrant in Patients With PIK3CA-mutated, HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer. JS105, Dalpiciclib, Fulvestrant 50 Mg/mL Intramuscular Solution - Breast Cancer | Phase 3 | Recruiting | Risen (Suzhou) Pharma Tech Co., Ltd. | 312 | 2025-11-12 | 2025-12-30 |
| Exploration of Dalpiciclib Plus HDACi in HR+/HER2- Advanced Breast Cancer After Failure of CDK4/6 Inhibitor Dalpiciclib, Chidamide, Enitinostat - HR+/HER2- Advanced Breast Cancer | Phase 2 | Not yet recruiting | Beijing 302 Hospital | 155 | 2025-10-01 | 2025-08-13 |
| Dalpiciclib With or Without Entinostat and Letrozole in HR+/HER2- Early Breast Cancer entinostat, Dalpiciclib, Letrozole - Breast Cancer | Phase 2 | Recruiting | Hebei Medical University Fourth Hospital | 60 | 2025-09-12 | 2026-04-02 |
| Maintenance Therapy in HER2-Positive Unresectable Locally Recurrent or Metastatic Breast Cancer: A Phase II Study Trastuzumab rezetecan, Pyrotinib, Dalpiciclib - HER2-positive Breast Cancer | Phase 2 | Not yet recruiting | Fudan University | 288 | 2025-09-10 | 2025-09-18 |
| Dalpiciclib as Adjuvant Therapy for HR-positive/HER2-negative Early-stage Patients Dalpiciclib, Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane) - Early Breast Cancer, Adjuvant Therapy | Phase 2 | Not yet recruiting | Fujian Cancer Hospital | 200 | 2025-09-01 | 2025-08-03 |
| ctDNA-Guided De-Escalation of Adjuvant Chemotherapy With Dalpiciclib in HR-Positive/HER2-Negative Breast Cancer Dalpiciclib + Aromatase Inhibitor with ctDNA-Guided Therapy, Taxane-Based Neoadjuvant Chemotherapy - Hormone Receptor-Positive Breast Cancer, High-risk Breast Cancer | Phase 2 | Recruiting | Peking University People's Hospital | 393 | 2025-08-01 | 2026-07-13 |
| Different Doses of Dalpicicl Combined With Letrozole in the First-line Treatment of HR-positive, HER2-negative Advanced Breast Cancer Dalpiciclib 125mg, Dalpiciclib 150mg, Letrozole 2.5mg - HR Positive HER2 Negative Advanced Breast Cancer | Phase 2 | Recruiting | wanghaibo | 120 | 2025-06-25 | 2025-12-16 |
| Multigene Risk Score Combined With Ki-67 Dynamic Assessment in Stratified Neoadjuvant Endocrine Therapy Treatment With or Without CDK4/6 Inhibitors in HR+/HER2- Breast Cancer Dalpiciclib, Letrozole - Breast Cancer, Early-stage Breast Cancer | Phase 2 | Enrolling by invitation | Peking University | 100 | 2025-05-01 | 2026-03-17 |
| The Efficacy and Safety of CDK4/6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment Ribociclib; abemaciclib; palbociclib; Dalpiciclib - Breast Cancer Stage III, Breast Cancer Stage II | Not applicable | Not yet recruiting | Hongmei Zheng, PhD | 40 | 2025-04-01 | 2025-03-17 |
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Breast Neoplasms (34) · Esophageal Squamous Cell Carcinoma (3) · Ovarian Neoplasms (2) · Squamous Cell Carcinoma of Head and Neck (2) · Brain Neoplasms (1) · Breast Diseases (1) · Carcinoma, Non-Small-Cell Lung (1) · Colorectal Neoplasms (1) · Meningioma (1) · Salivary Gland Neoplasms (1) · Triple Negative Breast Neoplasms (1)
Fudan University (10) · Hebei Medical University Fourth Hospital (4) · Fujian Cancer Hospital (3) · Tianjin Medical University Cancer Institute and Hospital (3) · Beijing 302 Hospital (2) · Henan Cancer Hospital (2) · Peking University (2) · Peking University Cancer Hospital & Institute (2) · Shengjing Hospital (2) · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (2) · West China Hospital (2) · Cancer Institute and Hospital, Chinese Academy of Medical Sciences (1) · Capital Medical University (1) · Fengzhi Feng (1) · Fujian Medical University (1)
China (45)
Jin Zhou, MD.,PhD. (2) · Cai-Gang Liu, PHD (1) · Cuizhi Geng Cuizhi Geng, archiater (1) · Fei Ma (1) · Guangdong Qiao (1) · Hongwei Zhang, MD, PhD (1) · Min Yan (1) · Tao Wang (1) · Wenjin Yin (1) · Xianming Luo, Doctor (1) · Xiaojian Wu, Ph.D (1) · Ying Wang (1) · Yue He, M.D. (1) · Zhaoqing Fan (1) · Zhenchuan Song (1)
PMID 35321427, PMID 38362377, PMID 38469548, PMID 39948624, PMID 40743286, PMID 42421507, PMID 42481711