17 recruiting, 11 unknown, 10 not yet recruiting, 2 active not recruiting. 42 Phase 2, 3 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 42 | Recruiting 17, Unknown 11, Not yet recruiting 10, Active not recruiting 2, Enrolling by invitation 1, Terminated 1 |
| Phase 1 | 3 | Unknown 2, Terminated 1 |
| Phase 3 | 1 | Not yet recruiting 1 |
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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| Study of Dalpiciclib Isethionate Plus Pyrotinib Maleate in the Treatment of Advanced Esophageal Squamous Cell Carcinoma Dalpiciclib + Pyrotinib - Esophageal Squamous Cell Carcinoma | Phase 2 | Recruiting | Peking University | 35 | 2024-11-01 | 2024-11-12 |
| Fluzoparib Combined With Dalpiciclib for Platinum Resistant Recurrent Ovarian Cancer Fluzoparib, Dalpiciclib - Ovarian Cancer | Phase 2 | Not yet recruiting | Fudan University | 30 | 2024-09-01 | 2024-08-14 |
| Osimertinib Plus Dalpiciclib in Patients With EGFR-mutant, CDK4/6 Pathway Aberrant, Advanced Non-small Cell Lung Cancer Following Acquired Resistance to Third-generation EGFR TKI: a Phase II Trial Osimertinib plus Dalpiciclib - Non-small Cell Lung Cancer, EGFR Activating Mutation | Phase 2 | Recruiting | Tianjin Medical University Cancer Institute and Hospital | 32 | 2024-04-09 | 2024-04-16 |
| Neoadjuvant Adebrelimab Plus Dalpiciclib in Head and Neck Squamous Cell Carcinoma Adebrelimab and dalpiciclib - Head and Neck Squamous Cell Carcinoma | Phase 2 | Not yet recruiting | Zhongzheng Xiang | 30 | 2024-01-31 | 2024-01-22 |
| Adebrelimab Combined With Dalpiciclib and Standard Endocrine Therapy for HR+/HER2 - Advanced Breast Cancer Adebrelimab, dalpiciclib - Breast Cancer | Phase 2 | Recruiting | Tongji Hospital | 82 | 2024-01-11 | 2024-04-15 |
| Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer Dalpiciclib, Endocrine therapy - Early Breast Cancer | Phase 2 | Recruiting | The First Affiliated Hospital with Nanjing Medical University | 1163 | 2023-11-17 | 2024-04-02 |
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Breast Neoplasms (25) · Esophageal Squamous Cell Carcinoma (2) · Ovarian Neoplasms (2) · Brain Neoplasms (1) · Breast Diseases (1) · Carcinoma, Non-Small-Cell Lung (1) · Colorectal Neoplasms (1) · Salivary Gland Neoplasms (1) · Squamous Cell Carcinoma of Head and Neck (1) · Triple Negative Breast Neoplasms (1)
Fudan University (10) · Hebei Medical University Fourth Hospital (3) · Tianjin Medical University Cancer Institute and Hospital (3) · Fujian Cancer Hospital (2) · Peking University (2) · Peking University Cancer Hospital & Institute (2) · Shengjing Hospital (2) · Beijing 302 Hospital (1) · Cancer Institute and Hospital, Chinese Academy of Medical Sciences (1) · Fengzhi Feng (1) · Henan Cancer Hospital (1) · Nanfang Hospital, Southern Medical University (1) · Peking University People's Hospital (1) · Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University (1) · Sixth Affiliated Hospital, Sun Yat-sen University (1)
China (34)
Cai-Gang Liu, PHD (1) · Fei Ma (1) · Guangdong Qiao (1) · Min Yan (1) · Tao Wang (1) · Xiaojian Wu, Ph.D (1) · Yue He, M.D. (1) · Zhaoqing Fan (1) · Zhenchuan Song (1) · Zhihao Lu, MD (1) · Zhimin Shao, MD,PhD (1) · Zhimin Shao, Professor (1)
PMID 35321427, PMID 38362377, PMID 38469548, PMID 39948624, PMID 40743286, PMID 42421507, PMID 42481711