75 recruiting, 64 completed, 46 active not recruiting, 26 terminated. 130 Phase 2, 86 Phase 1, 27 Phase 3, 7 Early Phase 1, 7 Phase 4.
Follow this drug Literature Review of abemaciclib trials Research Report on abemaciclib
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 |
|---|---|---|---|---|---|---|
| Imlunestrant/Abemaciclib/Selinexor in Ovarian and Endometrial Imlunestrant, Abemaciclib, Selinexor - Low Grade Ovarian Serous Adenocarcinoma, Endometrial Cancer | Phase 2 | Not yet recruiting | Dana-Farber Cancer Institute | 60 | 2026-12-01 | 2026-09-21 |
| QL1706 Plus Neoadjuvant Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer With a Poor Response to Neoadjuvant Chemotherapy Iparomlimab and Tuvonralimab (QL1706), Aromatase Inhibitor (AI), CDK4/6 inhibitor - Breast Cancer | Phase 2 | Not yet recruiting | Hebei Medical University Fourth Hospital | 40 | 2026-10-01 | 2026-08-26 |
| A Study of Abemaciclib (LY2835219) in Healthy Participants Abemaciclib Tablet (Test Formulation), Abemaciclib Tablet (Reference Formulation), Abemaciclib Oral Granules (Test Formulation) - Healthy Volunteers | Phase 1 | Recruiting | Eli Lilly and Company | 15 | 2026-09-02 | 2026-09-23 |
| 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 | 2026-08-01 | 2026-07-16 |
| Abemaciclib Combined With FOLFOX/FOLFIRI Regimen in Patients With Advanced Colorectal Liver Metastases Cancer Abemaciclib, Oxaliplatin, Calcium Folinate - Liver Metastases From Colorectal Cancer (mCRC) | Phase 2 | Enrolling by invitation | Fudan University | 16 | 2026-07-30 | 2026-07-22 |
| Neoadjuvant Imlunestrant Plus Abemaciclib Treatment Guided by Ki67 Index After 2 Weeks for ER-Positive HER2-Negative Breast Cancer Imlunestrant + abemaciclib, (dd)EC*4-T*4 - Breast Cancer | Phase 2 | Not yet recruiting | Fudan University | 189 | 2026-07-01 | 2026-02-18 |
| 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 | 2026-10-16 |
| Imlunestrant and Abemaciclib for the Treatment of Estrogen Receptor Positive Breast Cancer in Patients With Minimal Residual Disease, MIRI Trial Abemaciclib, Biospecimen Collection, Imlunestrant - Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8 | Phase 2 | Recruiting | Jonsson Comprehensive Cancer Center | 42 | 2026-05-18 | 2026-08-20 |
| Pragmatic Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+/HER2- Early Breast Cancer Using Oncotype DX and Abemaciclib Abemaciclib - Breast Cancer, HER2 + Breast Cancer | Phase 2 | Not yet recruiting | Mario Negri Institute for Pharmacological Research | 150 | 2026-04-30 | 2026-03-05 |
| Testing the Addition of an Anti-cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (Gemcitabine) for Soft Tissue Sarcoma Abemaciclib, Biopsy Procedure, Biospecimen Collection - Advanced Dedifferentiated Liposarcoma, Advanced Leiomyosarcoma | Phase 1 / Phase 2 | Recruiting | National Cancer Institute (NCI) | 74 | 2026-03-18 | 2026-10-21 |
| Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies SERD* + abemaciclib, SERD* + everolimus, SERD* + everolimus or capecitabine - Breast Cancer, Metastatic Breast Cancer | Phase 2 | Recruiting | UNC Lineberger Comprehensive Cancer Center | 700 | 2026-02-16 | 2026-09-18 |
| Abemaciclib for Molecular Residual Disease Detected by Circulating Tumor DNA in HR+/HER2- Early Breast Cancer Abemaciclib 150 MG Oral Tablet - ctDNA Monitoring, Breast Cancer | Phase 2 | Not yet recruiting | Nagoya City University | 30 | 2026-01-10 | 2025-12-18 |
| A Randomised Trial Comparing Trastuzumab Deruxtecan to CDK4/6 Inhibitors in Non-luminal A, ER-positive/HER2-low Metastatic Breast Cancer Trastuzumab deruxtecan (T-DXd), Ribociclib with ET, Abemaciclib with ET - Metastatic Breast Cancer, ER-positive Breast Cancer | Phase 3 | Withdrawn | Danish Breast Cancer Cooperative Group | 2026-01-01 | 2026-02-12 | |
| 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 |
| 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 Vaccine (STEMVAC) With Standard Endocrine-Based Therapy or Chemotherapy for the Treatment of Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine, Capecitabine, Computed Tomography - Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma | Phase 2 | Recruiting | University of Washington | 40 | 2025-11-17 | 2026-04-06 |
| A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer GDC-4198, Giredestrant, Abemaciclib - Breast Cancer | Phase 1 / Phase 2 | Recruiting | Genentech, Inc. | 285 | 2025-10-07 | 2026-10-06 |
| A Study of Elacestrant Alone or in Combination With Abemaciclib in People With Endometrial Cancer Abemaciclib, Elacestrant - Endometrial Cancer | Phase 2 | Recruiting | Memorial Sloan Kettering Cancer Center | 75 | 2025-10-01 | 2026-07-16 |
| A Precision Medicine Approach (SMMART-ACT) for the Treatment of Patients With Advanced Sarcoma, Prostate, Breast, Ovarian or Pancreatic Cancer Abemaciclib, Biopsy, Bone Scan - Advanced Breast Carcinoma, Advanced Malignant Solid Neoplasm | Phase 2 | Terminated | OHSU Knight Cancer Institute | 6 | 2025-06-24 | 2026-04-28 |
| 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 (105) · Neoplasm Metastasis (26) · Neoplasms (15) · Brain Neoplasms (13) · Endometrial Neoplasms (11) · Carcinoma, Non-Small-Cell Lung (10) · Prostatic Neoplasms (10) · Glioblastoma (7) · Ovarian Neoplasms (7) · Glioma (6) · Triple Negative Breast Neoplasms (6) · Breast Diseases (5) · Colorectal Neoplasms (5) · Head and Neck Neoplasms (5) · Squamous Cell Carcinoma of Head and Neck (5)
Eli Lilly and Company (60) · Dana-Farber Cancer Institute (11) · National Cancer Institute (NCI) (8) · Memorial Sloan Kettering Cancer Center (7) · AstraZeneca (6) · Fudan University (5) · Hoffmann-La Roche (5) · University of Washington (4) · M.D. Anderson Cancer Center (3) · Novartis Pharmaceuticals (3) · OHSU Knight Cancer Institute (3) · Pfizer (3) · Abramson Cancer Center at Penn Medicine (2) · Alliance for Clinical Trials in Oncology (2) · Blokhin's Russian Cancer Research Center (2)
United States (174) · Spain (56) · France (51) · Italy (47) · Australia (39) · Belgium (37) · Germany (36) · South Korea (36) · United Kingdom (31) · Japan (29) · Taiwan (28) · China (26) · Canada (24) · Turkey (Türkiye) (21) · Brazil (18)
Jose Pablo Leone, MD (2) · Mark Dickson, MD (2) · Nader Sanai, MD (2) · Panagiotis Konstantinopoulos, MD, PhD (2) · Priscilla Brastianos, MD (2) · Adam Crystal, MD, PhD (1) · Adrienne G Waks, MD (1) · Afshin Dowlati, MD (1) · Aixa Soyano, MD (1)
PMID 24919854, PMID 33149768, PMID 33392835, PMID 21796368, PMID 22198468, PMID 22623692, PMID 22649152, PMID 26432508, PMID 27406346, PMID 27406347, PMID 28533223, PMID 28540640, PMID 28580882, PMID 28851423, PMID 28968163, PMID 30082474, PMID 30675515, PMID 31401903, PMID 31563959, PMID 31615937, PMID 31744895, PMID 32031889, PMID 32053137, PMID 32353342, PMID 32450725, PMID 32479604, PMID 32537847, PMID 32694159, PMID 32701140, PMID 32954927, PMID 33068284, PMID 33090333, PMID 33194700, PMID 33229456, PMID 33492568, PMID 33515503, PMID 33660194, PMID 33686452, PMID 33797023, PMID 33844595, PMID 34425869, PMID 34465599, PMID 34529000, PMID 34661821, PMID 34741021, PMID 34746886, PMID 35076812, PMID 35084948, PMID 35086719, PMID 35157829
2023 (13), 2016 (7), 2019 (7), 2015 (5), 2014 (4), 2017 (3), 2025 (3), 2018 (2), P30CA060553 (2), UM1CA186689 (2), P30CA015083 (1), P30CA033572 (1), P30CA138292 (1), P50CA101942 (1), P50CA272390 (1)