145 completed, 67 active not recruiting, 46 recruiting, 40 unknown. 175 Phase 2, 121 Phase 1, 39 Phase 3, 7 Phase 4, 6 Early Phase 1.
Follow palbociclib: new trials by email Literature Review of palbociclib trials Research Report on palbociclib
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 |
|---|---|---|---|---|---|---|
| A Phase III Clinical Study of HRS-6209 Plus Letrozole as First-line Therapy in Patients With Advanced or Metastatic Breast Cancer HRS-6209 + Letrozole, Dalpciclib/Palbociclib + Letrozole/Anastrozole - Breast Cancer | Phase 3 | Not yet recruiting | Jiangsu HengRui Medicine Co., Ltd. | 1050 | 2026-11-20 | 2026-10-26 |
| A Study Evaluating the Safety of Inavolisib and Fulvestrant With or Without Palbociclib in Participants With Advanced Breast Cancer (ABC) and Type 2 Diabetes Inavolisib, Fulvestrant, Palbociclib - Breast Cancer, Diabetes Type II | Phase 2 | Recruiting | Hoffmann-La Roche | 40 | 2026-10-30 | 2026-10-20 |
| A Phase 1/2a Study of K-1728 in Advanced Solid Tumors K-1728, Fulvestrant, Palbociclib - Breast Neoplasms, Solid Tumors | Phase 1 / Phase 2 | Not yet recruiting | KymaThera, Inc. | 110 | 2026-10-01 | 2026-10-06 |
| T-DXd Based Therapy Followed by Endocrine Therapy Plus Dual HER2 Blockade in First-line HER2+/ HR+ Metastatic Breast Cancer and Retreatment With T-DXd Trastuzumab deruxtecan, Trastuzumab, Pertuzumab - Advanced Breast Cancer, Metastatic Breast Cancer | Phase 3 | Recruiting | Daiichi Sankyo | 200 | 2026-09-18 | 2026-10-16 |
| A Study of LAE118 as Monotherapy and in Combination With Antitumor Agents in Advanced Solid Tumors LAE118, Fulvestrant, Palbociclib - Patients With Advanced Solid Tumors | Phase 1 | Not yet recruiting | Laekna Limited | 150 | 2026-08-01 | 2026-08-26 |
| BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease BGB-43395, Letrozole, Abemaciclib - HR+/HER2- Breast Cancer | Phase 3 | Recruiting | BeOne Medicines | 1056 | 2026-05-22 | 2026-10-26 |
| A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer Inavolisib, Palbociclib, Fulvestrant - Locally Advanced Breast Cancer, Metastatic Breast Cancer | Recruiting | Hoffmann-La Roche | 500 | 2026-01-21 | 2026-10-06 | |
| Neoadjuvant Camrelizumab With Palbociclib for Resectable Esophageal Squamous Cell Carcinoma Camrelizumab, Palbociclib - Esophageal Squamour Cell Cancer | Phase 2 | Not yet recruiting | West China Hospital | 41 | 2026-01-01 | 2025-09-25 |
| A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA) LY4064809, Placebo, Ribociclib - Breast Neoplasms, Neoplasm Metastasis | Phase 3 | Recruiting | Eli Lilly and Company | 800 | 2025-12-22 | 2026-10-08 |
| An Exploratory Study of Pertuzumab and Trastuzumab in Combination With Palbociclib and Exemestane as Neoadjuvant Therapy for Triple-Positive Breast Cancer Trastuzumab and Pertuzumab Combination with Palbociclib and Exemestane - Breast Cancer | Phase 2 | Not yet recruiting | Anhui Provincial Cancer Hospital | 90 | 2025-12-20 | 2025-12-23 |
| Clinical and Therapeutic Outcomes by Molecular Subtype in Breast Cancer CDK4/6 Inhibitors, Anti-HER2 Therapy, Standard Breast Cancer Treatment - Breast Neoplasms, Triple Negative Breast Neoplasms | Recruiting | Fundación Santa Fe de Bogota | 370 | 2025-12-01 | 2026-10-02 | |
| A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma Sasanlimab, Palbociclib, Axitinib - Metastatic Renal Cell Carcinoma, Metastatic Renal Cancer | Phase 2 | Recruiting | Stephanie Berg | 25 | 2025-11-24 | 2026-08-20 |
| A Trial of the Combination of Afatinib and Palbociclib in Previously Treated Advanced Esophageal Squamous Cell Carcinoma Palbociclib, Afatinib(30mg), Afatinib(40mg) - Esophagus Cancer | Phase 1 / Phase 2 | Recruiting | West China Hospital | 45 | 2025-09-10 | 2025-12-03 |
| Effectiveness and Safety of Palbociclib: Brand vs. Generic in Iraqi Stage IV Breast Cancer Patients Palbociclib (Brand vs Generic) compartive - Brest Cancer, CDK4/6 Inhibitor | Active not recruiting | Al-Mustansiriyah University | 100 | 2025-09-07 | 2026-03-30 | |
| A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors BMS-986500, Palbociclib, Fulvestrant - Advanced Solid Tumor, Advanced Breast Cancer | Phase 1 | Recruiting | Bristol-Myers Squibb | 234 | 2025-08-01 | 2026-10-06 |
| Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2) Arm A: Gedatolisib + Palbociclib + Fulvestrant, Arm B: Ribociclib + Fulvestrant, Arm C: Gedatolisib + Palbociclib + Letrozole - Breast Cancer | Phase 3 | Recruiting | Celcuity Inc | 1180 | 2025-07-24 | 2026-10-09 |
| Comparing Endocrine Therapy Combined With High-Dose Palbociclib and Hydroxychloroquine to Endocrine Therapy Combined With Standard-Dose Palbociclib for Hormone Receptor-Positive and HER2-Negative Advanced Breast Cancer Palbociclib 125mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd, Palbociclib 125mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd + Hydroxychloroquine 600mg bid, Palbociclib 200mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd + Hydroxychloroquine 600mg bid - Hormone Receptor-Positive and HER2-Negative Advanced Breast Cancer | Phase 3 | Not yet recruiting | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | 474 | 2025-07-01 | 2025-07-11 |
| A Study to Understand the Patients Confirmed to Have Advanced or Metastatic Breast Cancer and Receiving Palbociclib Treatment Using a Real-world Database Ibrance - Advanced or Metastatic Breast Cancer | Completed | Pfizer | 1 | 2025-06-30 | 2026-08-20 | |
| A Study of Almonertinib Combined With Palbociclib in Patients With Advanced Solid Tumors Harboring KRAS Mutations Almonertinib, Palbociclib - EGFR Tyrosine Kinase Inhibitors Plus Cyclin-dependent Kinase 4/6 Inhibitor | Phase 1 / Phase 2 | Recruiting | Sun Yat-sen University | 71 | 2025-06-09 | 2025-06-04 |
| A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC FWD1802, Palbociclib 125mg, Ribociclib 200Mg Oral Tablet - Metastatic Breast Cancer, Breast Cancer Stage I | Phase 1 / Phase 2 | Recruiting | Forward Pharmaceuticals Co., Ltd. | 196 | 2025-06-01 | 2026-01-07 |
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Breast Neoplasms (194) · Neoplasm Metastasis (24) · Neoplasms (22) · Ovarian Neoplasms (12) · Sarcoma (10) · Pancreatic Neoplasms (9) · Squamous Cell Carcinoma of Head and Neck (8) · Carcinoma, Non-Small-Cell Lung (7) · Colorectal Neoplasms (7) · Endometrial Neoplasms (7) · Melanoma (7) · Breast Diseases (6) · Head and Neck Neoplasms (6) · Precursor Cell Lymphoblastic Leukemia-Lymphoma (6) · Prostatic Neoplasms (6)
Pfizer (51) · Hoffmann-La Roche (10) · National Cancer Institute (NCI) (10) · Dana-Farber Cancer Institute (9) · AstraZeneca (8) · Washington University School of Medicine (6) · MedSIR (5) · Memorial Sloan Kettering Cancer Center (5) · Abramson Cancer Center at Penn Medicine (4) · Georgetown University (4) · M.D. Anderson Cancer Center (4) · Royal Marsden NHS Foundation Trust (4) · Weill Medical College of Cornell University (4) · Alliance Foundation Trials, LLC. (3) · Canadian Cancer Trials Group (3)
United States (196) · Spain (62) · China (48) · Italy (45) · United Kingdom (45) · Australia (41) · France (41) · Germany (40) · South Korea (39) · Canada (35) · Japan (28) · Belgium (26) · Taiwan (25) · Poland (20) · Hungary (19)
Alicia Okines (2) · Angela DeMichele, MD (2) · Claudine Isaacs, MD (2) · Cynthia X Ma, M.D., Ph.D. (2) · Douglas Adkins, M.D. (2) · Evanthia Galanis, MD (2) · Jin Zhou (2) · Jonas Bergh, Professor (2) · Nehman Makdissy, Professor (2)
PMID 30032196, PMID 29342248, PMID 29522361, PMID 30053671, PMID 31127500, PMID 32164785, PMID 33486783, PMID 25524798, PMID 27959613, PMID 30807234, PMID 32641862, PMID 32783178, PMID 33369581, PMID 33955129, PMID 35974168, PMID 36463643, PMID 37553297, PMID 38861871, PMID 12954578, PMID 19164198, PMID 19238148, PMID 22383795, PMID 23569312, PMID 24043732, PMID 24104881, PMID 24669852, PMID 25813205, PMID 26030518, PMID 26410619, PMID 26586415, PMID 26894413, PMID 26947331, PMID 26991823, PMID 27029704, PMID 27124835, PMID 27238653, PMID 27269946, PMID 27368881, PMID 28652278, PMID 29162134, PMID 29326029, PMID 29360932, PMID 29404806, PMID 29742701, PMID 29893769, PMID 29893790, PMID 30032243, PMID 30151703, PMID 30307465, PMID 30307466
2023 (13), 2017 (10), 2014 (8), 2015 (6), 2019 (5), 2016 (4), 2018 (4), U10CA180820 (4), 2025 (3), P30CA138292 (3), P30CA060553 (2), U10CA180886 (2), U10CA180888 (2), U24CA196172 (2), UM1CA186704 (2)