25 completed, 21 recruiting, 17 active not recruiting, 9 terminated. 81 Phase 2, 27 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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer Inavolisib, Ribociclib, Letrozole - Breast Cancer | Phase 2 | Recruiting | Hoffmann-La Roche | 120 | 2025-09-09 | 2026-10-26 |
| Impact of Omitting Chemo Based on Patient's Selection for ER-Positive, HER2-Negative Breast Cancer With Ribociclib and Endocrine Therapy Ribociclib 400mg, Letrozole 2.5mg, Anastrazole 1mg - HER2 Negative Breast Cancer | Phase 2 | Recruiting | Yale University | 140 | 2025-07-09 | 2026-05-26 |
| 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 |
| Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and in Patients With Other Advanced Solid Tumors ECI830, ribociclib, fulvestrant - Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors | Phase 1 / Phase 2 | Recruiting | Novartis Pharmaceuticals | 280 | 2025-04-03 | 2026-08-27 |
| Study of Ribociclib and Everolimus in HGG and DIPG or Ribociclib and Temozolomide in DHG, H3G34-mutant Ribociclib, Everolimus, Temozolomide (TMZ) - High Grade Glioma, Diffuse Intrinsic Pontine Glioma | Phase 2 | Recruiting | Nationwide Children's Hospital | 120 | 2024-08-22 | 2026-05-29 |
| Sequential Therapies Modeled on Evolutionary Dynamics for Breast Cancer Taxotere, Cytoxan, Trastuzumab deruxtecan - Metastatic Breast Cancer | Phase 2 | Recruiting | H. Lee Moffitt Cancer Center and Research Institute | 15 | 2024-08-14 | 2025-12-04 |
| First-Line Ribociclib Plus Endocrine Therapy Versus Chemotherapy With or Without Subsequent Endocrine Therapy in Patients With Rapidly Progressive HR-Positive/HER2-Negative Advanced Breast Cancer Ribociclib - Advanced Breast Cancer | Phase 2 | Completed | The First Affiliated Hospital with Nanjing Medical University | 74 | 2024-01-09 | 2026-08-05 |
| A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors AZD8421, Camizestrant, Ribociclib - ER+ HER2- Advanced Breast Cancer, High-grade Serous Ovarian Cancer (HGSOC) | Phase 1 / Phase 2 | Active not recruiting | AstraZeneca | 55 | 2023-12-05 | 2026-10-28 |
| Trastuzumab Deruxtecan Versus Standard Neoadjuvant Treatment for HER2-positive Breast Cancer Trastuzumab deruxtecan, Docetaxel, Paclitaxel - Breast Cancer | Phase 2 | Recruiting | Karolinska University Hospital | 370 | 2023-10-26 | 2025-09-02 |
| T-DM1 Combined With CDK4/6 Inhibitor Ribociclib Ribociclib Oral Tablet - HER2-positive Advanced Breast Cancer | Phase 2 | Enrolling by invitation | Zheng Yabing | 40 | 2023-10-25 | 2024-07-01 |
| Detection of Tumor DNA in the Blood of Patients Receiving Standard Therapy for Hormone Receptor-positive (HR+) Non-HER2 Expressing (HER2-) Metastatic Breast Cancer as a Tool to Select Those Who May Benefit From the Next Course of Fulvestrant in Combination With Alpelisib or Ribociclib Alpelisib, Ribociclib - Breast Cancer Stage IV | Phase 2 | Terminated | UNICANCER | 4 | 2023-10-19 | 2026-10-14 |
| Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer elacestrant, palbociclib, abemaciclib, ribociclib - Estrogen-receptor-positive Breast Cancer, HER2/Neu-Negative Breast Cancer | Phase 2 | Recruiting | Northwestern University | 174 | 2023-09-29 | 2026-09-04 |
| Study of AVZO-021 in Patients With Advanced Solid Tumors AVZO-021, Palbociclib, Fulvestrant - Advanced Solid Tumor, HR+/HER2- Breast Cancer | Phase 1 / Phase 2 | Recruiting | Avenzo Therapeutics, Inc. | 430 | 2023-08-30 | 2026-09-28 |
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Breast Neoplasms (42) · Melanoma (5) · Neoplasms (4) · Endometrial Neoplasms (3) · Liposarcoma (3) · Neoplasm Metastasis (3) · Ovarian Neoplasms (3) · Sarcoma (3) · Diffuse Intrinsic Pontine Glioma (2) · Fallopian Tube Neoplasms (2) · Glioma (2) · Prostatic Neoplasms (2) · Triple Negative Breast Neoplasms (2) · Astrocytoma (1) · Brain Neoplasms (1)
Novartis Pharmaceuticals (14) · Hoffmann-La Roche (4) · Pfizer (4) · M.D. Anderson Cancer Center (3) · SOLTI Breast Cancer Research Group (2) · Antares Therapeutics, Inc (1) · Array BioPharma (1) · Assaf-Harofeh Medical Center (1) · AstraZeneca (1) · Avenzo Therapeutics, Inc. (1) · Borstkanker Onderzoek Groep (1) · Centre Antoine Lacassagne (1) · Centre Leon Berard (1) · Children's Hospital Medical Center, Cincinnati (1) · City of Hope Medical Center (1)
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A. E van Leeuwen-Stok, PhD (1) · Aixa Soyano, MD (1) · Aleix Prat, MD (1) · Aleix Prat, PhD (1) · Alex Menzies (1) · Alexios Matikas, MD/PhD (1) · Alicia Okines (1) · Arielle Medford, MD (1) · Array BioPharma (1) · Benjamin Weinberg, MD (1) · Birgit Geoerger, MD (1) · Brian Slomovitz, MD (1)
PMID 34376578, PMID 42334791, PMID 17513820, PMID 27336726, PMID 31235441, PMID 31538815, PMID 31838010, PMID 32354716, PMID 32669376, PMID 33034839, PMID 33109627, PMID 33640871, PMID 33892407, PMID 34347542, PMID 34543871, PMID 35086719, PMID 35292802, PMID 35294522, PMID 35587446, PMID 35598186, PMID 36067616, PMID 36800111, PMID 36870947, PMID 37424386, PMID 37690320, PMID 38630551, PMID 38771995, PMID 39073142, PMID 40866060, PMID 40996770, PMID 41838385, PMID 41914670, PMID 41986720, PMID 42602220, PMID 42686334, PMID 42688140, PMID 42747616, PMID 42823426
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