Data updated: Jun 17, 2026
RIBOCICLIB
Trial Activity: Growth 55 active trials
Oncology
Development Insights
Novartis Pharmaceuticals conducting 26 trials (26%)
263 indications explored (Broad Platform)
→ breast cancer (35 trials)
→ metastatic breast cancer (11 trials)
→ her2-negative breast cancer (6 trials)
Details
- Status
- None (Tentative Approval)
- First Approved
- N/A
- Routes
- ORAL
- Dosage Forms
- TABLET
RIBOCICLIB Approval History
No approval records found
📋
Clinical Trial Registry
101 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06377852 | Pro00075309 | Ph 3 | recruiting | The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study |
| NCT04802759 | CO42867 2020-004889-19, 2023-507495-48-00 | Ph 1, Ph 2 | recruiting | A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer |
| NCT06188520 CYCAD-1 | D8470C00001 | Ph 1, Ph 2 | recruiting | 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 |
| NCT05319873 | 21-001819 NCI-2021-11707 | Ph 1, Ph 2 | active not recruiting | Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2 Positive Breast Cancer |
| NCT05827081 Adjuvant WIDER | CLEE011O12001 2022-503001-38-00 | Ph 3 | recruiting | Phase IIIb Study of Ribociclib + ET in Early Breast Cancer |
| NCT06065748 | CO44657 2022-502980-39-00 | Ph 3 | recruiting | 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) |
| NCT05870579 | CAAA603B12101 2022-502465-18-00 | Ph 1 | recruiting | [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer |
| NCT07174336 | 27726 J6M-MC-JSGD, 2025-522791-92-00 | Ph 3 | recruiting | A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA) |
| NCT07054190 | BO45853 2024-518811-20-00 | Ph 2 | recruiting | A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer |
| NCT07492641 KANDELA-302 | BGB-43395-302 2025-523960-19-00 | Ph 3 | recruiting | 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 |
| NCT06726148 | CECI830A12101 2024-517281-42 | Ph 1, Ph 2 | recruiting | Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and Other Advanced Solid Tumors |
| NCT04116541 MegaMOST | ET19-073 (MegaMOST) 2023-510567-35-00, 2019-001494-88 | Ph 2 | recruiting | A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors. |
| NCT05768139 PIKALO-1 | 27691 2023-504807-94-00, 2023-000442-41 | Ph 1, Ph 2 | recruiting | First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors |
| NCT05843253 | CONNECT TarGeT-A R01FD008167 | Ph 2 | recruiting | Study of Ribociclib and Everolimus in HGG and DIPG or Ribociclib and Temozolomide in DHG, H3G34-mutant |
| NCT02555189 results posted | 15G.322 CLEE011XUS12T, c15-153 | Ph 1, Ph 2 | terminated | Enzalutamide With Ribociclib in Treating Patients With Metastatic Castrate-Resistant, Chemotherapy Naive Prostate Cancer That Retains Retinoblastoma Expression |
| NCT05683418 | TOS-358-001 2023-505346-26-01 | Ph 1 | recruiting | A Study to Evaluate the Safety and Tolerability of TOS-358 in Women With HR+ HER2- Breast Cancer |
| NCT04964934 SERENA-6 | D8534C00001 2023-503990-39-00, 2021-000546-17 | Ph 3 | active not recruiting | Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6) |
| NCT04862663 CAPItello-292 | D361DC00001 2020-004637-20 | Ph 3 | recruiting | Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292) |
| NCT07405801 | CO46274 2025-523013-28-00 | Ph 2 | recruiting | 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 |
| NCT07085767 OPERA-02 | OP-1250-302 OPERA-02 | Ph 3 | recruiting | Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer |
| NCT05238922 | INCB 123667-101 2021-005357-91 | Ph 1 | recruiting | Study of INCB123667 in Subjects With Advanced Solid Tumors |
| NCT05358249 KontRASt-03 | CJDQ443E12101 2021-006196-42 | Ph 1, Ph 2 | active not recruiting | Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation |
| NCT06380751 EvoPAR-BR01 | D9722C00001 | Ph 3 | recruiting | Saruparib (AZD5305) Plus Camizestrant 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 |
| NCT06625775 | TBBO10203-101 2024-519445-29-00, BREAKER-101 | Ph 1 | recruiting | Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors |
| NCT05467891 RaPhLRR | HCRN BRE20-468 | Ph 2 | recruiting | Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer |
| NCT05161195 | CLEE011A2412B 2024-514891-41-00 | Ph 4 | active not recruiting | Roll-over Study to Allow Continued Access to Ribociclib |
| NCT03701334 NATALEE | CLEE011O12301C 2023-510357-42-00, TRIO033 | Ph 3 | active not recruiting | A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer |
| NCT07487129 Clinical and P | 7-2025/5 | Ph 4 | completed | Clinical and Pharmacoeconomic Assessment of CDK4/6 Inhibitors for Treatment of Breast Cancer in Egypt |
| NCT04417621 | CLXH254C12201 2020-000873-26 | Ph 2 | active not recruiting | Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma |
| NCT02712723 FELINE results posted | CLEE011XUS10T | Ph 2 | active not recruiting | Letrozole Plus Ribociclib or Placebo as Neo-adjuvant Therapy in ER-positive, HER2-negative Early Breast Cancer |
| NCT02780128 NEPENTHE | 14-011071 | Ph 1 | terminated | Next Generation Personalized Neuroblastoma Therapy |
| NCT05573555 | C4891023 2022-502231-19-00 | Ph 1, Ph 2 | active not recruiting | TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study B) |
| NCT06760637 FourLight-3 | C4391024 2024-512925-95-00 | Ph 3 | active not recruiting | 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 |
| NCT03008408 | 2015-0961 NCI-2018-01284, 2015-0961 | Ph 2 | active not recruiting | A Phase II, Two-Arm Study of Everolimus and Letrozole, +/- Ribociclib (Lee011) in Patients With Advanced or Recurrent Endometrial Carcinoma |
| NCT05996107 | UMCC 2022.071 HUM00231659 | Ph 1 | recruiting | Study of Ribociclib Administered Concurrently With Postoperative Radiation Therapy in Patients With High-Risk, HR+/HER2- Breast Cancer |
| NCT03333343 | CEGF816X2102 2024-511757-21-00 | Ph 1 | active not recruiting | Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC |
| NCT02813135 ESMART | 2016-000133-40 2016/2396, 2024-514791-40-00 | Ph 1, Ph 2 | recruiting | European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors |
| NCT05563220 ELEVATE | STML-ELA-0222 | Ph 1, Ph 2 | active not recruiting | Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer |
| NCT03090165 | BTCRC BRE15-024 | Ph 1, Ph 2 | active not recruiting | Ribociclib and Bicalutamide in AR+ TNBC |
| NCT03673124 results posted | GOG-3026 | Ph 2 | active not recruiting | Ribociclib and Letrozole Treatment in Ovarian Cancer |
| NCT03285412 LEADER | 17-232 | Ph 2 | active not recruiting | CDK 4/6 Inhibitor, Ribociclib, With Adjuvant Endocrine Therapy for ER-positive Breast Cancer |
| NCT06409390 | MCC-22617 | Ph 2 | recruiting | Sequential Therapies Modeled on Evolutionary Dynamics for Breast Cancer |
| NCT05252416 | BLU-222-1101 | Ph 1 | terminated | (VELA) Study of BLU-222 in Advanced Solid Tumors |
| NCT03740334 | 18-328 | Ph 1 | active not recruiting | Ribociclib in Combination With Everolimus and Dexamethasone in Relapsed ALL |
| NCT05867251 | AVZO-021-1001 | Ph 1, Ph 2 | recruiting | Study of AVZO-021 in Patients With Advanced Solid Tumors |
| NCT03671330 | CLEE011A2206 | Ph 2 | completed | Efficacy and Safety of Ribociclib in Pre- and Postmenopausal Chinese Women With HR Positive, HER2-negative, Advanced Breast Cancer. |
| NCT05508906 | OP-1250-003 | Ph 1 | recruiting | Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer |
| NCT03822468 AMALEE results posted | CLEE011A2207 2018-004234-15 | Ph 2 | completed | Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer |
| NCT05429502 | CLEE011Q12101 2024-512095-35-00 | Ph 1 | terminated | Study of Efficacy and Safety of Ribociclib (LEE011) in Combination With Topotecan and Temozolomide (TOTEM) in Pediatric Patients With Relapsed or Refractory Neuroblastoma and Other Solid Tumors |
| NCT07195227 CADILLAC | MEDOPP555 | Ph 2 | recruiting | Efficacy and Safety of Camizestrant Plus Ribociclib in Patients With Breast Cancer |
Showing 50 of 101 trials
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
RIBOCICLIB FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment