60 completed, 44 recruiting, 39 active not recruiting, 29 terminated. 81 Phase 2, 75 Phase 1, 31 Phase 3, 6 Phase 4, 4 Early Phase 1.
Follow ribociclib: new trials by email Literature Review of ribociclib trials Research Report on ribociclib
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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 to Evaluate ATX-898 in Participants With Advanced Solid Tumors ATX-898, ATX-898, fulvestrant, ribociclib - Advanced Solid Tumors | Phase 1 / Phase 2 | Recruiting | Antares Therapeutics, Inc | 343 | 2026-08-31 | 2026-10-16 |
| Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial Anastrozole, Biospecimen Collection, Bone Scan - Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8 | Phase 3 | Recruiting | National Cancer Institute (NCI) | 1978 | 2026-08-10 | 2026-10-26 |
| A Study to Investigate the Efficacy and Safety of Letrozole SIE Compared With Femara® (Both Combined With the CDK4/6 Inhibitor Ribociclib) in Postmenopausal Women With HR-Positive, HER2-Negative, Inoperable Locally Advanced or Metastatic Breast Cancer Letrozole SIE + Ribociclib + Oral placebo, Oral Femara® + Ribociclib + Injectable placebo - Advanced, Metastatic Breast Cancer | Phase 3 | Not yet recruiting | Rovi Pharmaceuticals Laboratories | 300 | 2026-08-01 | 2026-04-02 |
| A Phase IIIb Study to Evaluate Camizestrant Plus Ribociclib in ER-positive, HER2-negative Advanced Breast Cancer Camizestrant, Ribociclib - ER-Positive HER2-Negative Breast Cancer | Phase 3 | Recruiting | AstraZeneca | 150 | 2026-06-15 | 2026-10-19 |
| A Phase ll, Interventional, Single-arm Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib and Fulvestrant in Chinese Patients With PIK3CA-mutant, HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer. Inavolisib + Ribociclib + Fulvestrant - Breast Cancer | Phase 2 | Not yet recruiting | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | 160 | 2026-06-01 | 2026-06-01 |
| 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 Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer Inavolisib, Ribociclib, Fulvestrant - Breast Cancer | Phase 2 | Recruiting | Hoffmann-La Roche | 80 | 2026-04-07 | 2026-10-06 |
| Efficacy and Safety of Camizestrant Plus Ribociclib in Patients With Breast Cancer Camizestrant, Ribociclib - Hormon Receptor Positive Breast Cancer, Breast Cancer | Phase 2 | Recruiting | MedSIR | 150 | 2026-03-24 | 2026-05-29 |
| Ribociclib in Hormone Receptor-positive, HER2-negative Early Breast Cancer With Residual Disease After Neoadjuvant Chemotherapy Ribociclib plus aromatase inhibitor, Aromatase inhibitor - Breast Cancer | Phase 3 | Recruiting | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | 446 | 2026-02-10 | 2026-04-28 |
| Fulvestrant With Ribociclib Versus Physician's Choice Treatments Recurred After Completion of Adjuvant Cyclin-Dependent Kinase 4/6 Inhibitors in HR+, HER2- Metastatic Breast Cancer Ribociclib with fulvestrant, Physician's choice treatments group - Breast Cancer Metastatic | Phase 2 | Not yet recruiting | Yeon Hee Park | 272 | 2026-02-01 | 2025-12-24 |
| Implementation Study to Describe and Compare Retention Rate and Adherence to Adjuvant Therapy With Ribociclib With and Without Usage of Mobile Application in Patients With HR+ HER2-negative Stage II and III Breast Cancer in Real-world Practice Ribociclib, Letrozole, Anastrozole - Breast Cancer | Recruiting | Novartis Pharmaceuticals | 240 | 2026-01-23 | 2026-05-05 | |
| 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 |
| Chemotherapy De-escalation in HR +, HER2-, Intermediate-risk Early Breast Cancer Treated With Adjuvant Ribociclib Chemotherapy followed by endocrine therapy and ribociclib treatment, De-escalation - Breast Cancer | Phase 3 | Recruiting | UNICANCER | 3902 | 2025-12-18 | 2026-05-26 |
| Non-interventional Study to Assess the Effectiveness and Safety of Ribociclib in the Adjuvant Therapy of Hormone Receptor Positive (HR+) HER2-negative Stage II and III Breast Cancer in Real Clinical Practice in Russia Ribociclib, Letrozole, Anastrozole - Breast Cancer | Recruiting | Novartis Pharmaceuticals | 2766 | 2025-12-03 | 2026-08-10 | |
| 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 | |
| Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer Palazestrant, Letrozole-matching placebo, Ribociclib - Breast Cancer, Locally Advanced Breast Cancer | Phase 3 | Recruiting | Olema Pharmaceuticals, Inc. | 1000 | 2025-11-03 | 2026-09-23 |
| Ribociclib for HR-positive HER2-negative Metastatic Breast Cancer Ribociclib 400mg, Ribociclib 600mg - Breast Cancer | Phase 1 / Phase 2 | Recruiting | Nagoya City University | 86 | 2025-10-01 | 2026-04-13 |
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Novartis Pharmaceuticals (56) · Pfizer (7) · AstraZeneca (6) · Hoffmann-La Roche (5) · Dana-Farber Cancer Institute (3) · M.D. Anderson Cancer Center (3) · SOLTI Breast Cancer Research Group (3) · Children's Hospital Medical Center, Cincinnati (2) · Eli Lilly and Company (2) · Fondazione Policlinico Universitario Agostino Gemelli IRCCS (2) · Fox Chase Cancer Center (2) · Georgetown University (2) · H. Lee Moffitt Cancer Center and Research Institute (2) · Mayo Clinic (2) · National Taiwan University Hospital (2)
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Aleix Prat, MD (2) · Nader Sanai, MD (2) · A. E van Leeuwen-Stok, PhD (1) · Abdullah Sakin, Assoc. Prof. (1) · Aixa Soyano, MD (1) · Aleix Prat, PhD (1) · Alex Adjei (1) · Alex Menzies (1) · Alexios Matikas, MD/PhD (1)
PMID 42334791, PMID 36800111, PMID 31305131, PMID 33769862, PMID 34158598, PMID 37673211, PMID 17513820, PMID 34376578, PMID 39826197, PMID 27336726, PMID 27717303, PMID 29059492, PMID 29404806, PMID 29718092, PMID 29804902, PMID 29860922, PMID 30340505, PMID 30941307, PMID 31166679, PMID 31235441, PMID 31399936, PMID 31538815, PMID 31826360, PMID 31838010, PMID 32354716, PMID 32619077, PMID 32669376, PMID 32887722, PMID 33034839, PMID 33109627, PMID 33555033, PMID 33640871, PMID 33892407, PMID 34102253, PMID 34347542, PMID 34414532, PMID 34433648, PMID 34504990, PMID 34543871, PMID 34953442, PMID 34965945, PMID 35086719, PMID 35212906, PMID 35263519, PMID 35292802, PMID 35294522, PMID 35587446, PMID 35598186, PMID 35972817, PMID 36067616
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