10 recruiting, 7 active not recruiting, 6 completed, 4 terminated. 31 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 31 | Recruiting 10, Active not recruiting 7, Completed 6, Terminated 4, Withdrawn 2, Not yet recruiting 1, Unknown 1 |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 |
|---|---|---|---|---|---|---|
| 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 | 2026-10-30 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease PF-07220060, letrozole, abemaciclib - Breast Cancer | Phase 3 | Active not recruiting | Pfizer | 1035 | 2025-01-06 | 2026-10-16 |
| The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study Palbociclib 125mg, Ribociclib 600mg, Ribociclib - Metastatic Breast Cancer | Phase 3 | Recruiting | American Society of Clinical Oncology | 500 | 2024-10-29 | 2026-10-06 |
| Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer Saruparib (AZD5305), Camizestrant, Abemaciclib - Advanced Breast Cancer | Phase 3 | Recruiting | AstraZeneca | 788 | 2024-08-01 | 2026-10-30 |
| Phase IIIb Study of Ribociclib + ET in Early Breast Cancer Ribociclib, Letrozole, Ansastrozole - Early Breast Cancer | Phase 3 | Active not recruiting | Novartis Pharmaceuticals | 1464 | 2024-02-28 | 2026-10-23 |
| A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer) Giredestrant, Fulvestrant, Abemaciclib - Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer | Phase 3 | Active not recruiting | Hoffmann-La Roche | 1050 | 2023-12-11 | 2026-09-14 |
| Ribociclib vs. Palbociclib in Patients With Advanced Breast Cancer Within the HER2-Enriched Intrinsic Subtype Ribociclib + Letrozole OR Fulvestrant, Palbociclib + Letrozole OR Fulvestrant, Paclitaxel +/- Tislelizumab - Metastatic Breast Cancer | Phase 3 | Terminated | SOLTI Breast Cancer Research Group | 61 | 2022-03-28 | 2026-06-25 |
| Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6) AZD9833, AZD9833 Placebo, Anastrozole - ER-Positive HER2-Negative Breast Cancer | Phase 3 | Active not recruiting | AstraZeneca | 315 | 2021-06-30 | 2026-09-23 |
| Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292) Capivasertib, Fulvestrant, Palbociclib - Locally Advanced (Inoperable) or Metastatic Breast Cancer | Phase 3 | Active not recruiting | AstraZeneca | 893 | 2021-05-10 | 2026-08-17 |
| Adj. Marker-adjusted Personalized Therapy Comparing ET+Ribociclib vs Chemotherapy in Intermediate Risk, HR+/HER2- EBC Ribociclib 200Mg Oral Tablet - Breast Cancer Female | Phase 3 | Active not recruiting | Women's Cancer Study Group GmbH | 1684 | 2019-07-02 | 2026-10-09 |
| Ribociclib-endocrine Combination Therapy Versus Chemotherapy as 1st Line in Visceral mBC Ribociclib, Mono-chemotherapy, Endocrine-Therapy - Breast Cancer | Phase 3 | Terminated | Swiss Cancer Institute | 25 | 2019-06-25 | 2021-06-16 |
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Breast Neoplasms (25) · Neoplasm Metastasis (4) · Breast Diseases (3) · Neoplasms (3) · Neoplasms by Site (3) · Multiple Endocrine Neoplasia Type 1 (2) · Breast Neoplasms, Male (1) · Hereditary Sensory and Autonomic Neuropathies (1) · Osteitis Deformans (1) · Recurrence (1) · Unilateral Breast Neoplasms (1)
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