Ribociclib
Information
- Drug Name
- Ribociclib
- Description
- Entry(CIViC)
- 2
CIViC
| Disease | Mutation | EL | ET | ED | CS | VO | TR | Pubmed | Links |
|---|---|---|---|---|---|---|---|---|---|
| breast cancer | PIK3CA MUTATION PIK3CA MUTATION | D |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 4 | 25002028 | Detail |
| skin melanoma | NRAS MUTATION NRAS MUTATION | B |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 3 | 26987942 | Detail |
Annotation
| Description | Associated Genes | Associated Variants | Sensitivity | Supported | Source | Links |
|---|---|---|---|---|---|---|
| Three PI3K mutant breast cancer cell lines were re... | PIK3CA | PIK3CA MUTATION PIK3CA MUTATION | Sensitivity | true | CIViC Evidence | detail |
| Inhibition of CDK4 and 6, regulators of the G1/S c... | NRAS | NRAS MUTATION NRAS MUTATION | Sensitivity | true | CIViC Evidence | detail |
| NCT ID | Status | Phase | Summary | Start date | Completion date |
|---|---|---|---|---|---|
| NCT03701334 | Active, not recruiting | Phase 3 | A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer | December 7, 2018 | May 29, 2026 |
| NCT03740334 | Active, not recruiting | Phase 1 | Ribociclib in Combination With Everolimus and Dexamethasone in Relapsed ALL | January 30, 2019 | September 30, 2024 |
| NCT03822468 | Active, not recruiting | Phase 2 | Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer | June 11, 2019 | July 1, 2024 |
| NCT03944434 | Active, not recruiting | Phase 2 | FACILE: FeAsibility of First-line riboCIclib in oLdEr Patients With Advanced Breast Cancer | December 27, 2018 | November 27, 2025 |
| NCT05759949 | Active, not recruiting | Phase 1 | First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors | March 29, 2023 | July 25, 2024 |
| NCT02608216 | Active, not recruiting | Phase 1 | [18F]FLT PET/CT in Rb+ Metastatic Breast Cancer | November 2015 | November 2024 |
| NCT02712723 | Active, not recruiting | Phase 2 | Letrozole Plus Ribociclib or Placebo as Neo-adjuvant Therapy in ER-positive, HER2-negative Early Breast Cancer | February 2016 | April 2023 |
| NCT02933736 | Active, not recruiting | Early Phase 1 | Ribociclib (LEE011) in Preoperative Glioma and Meningioma Patients | October 2016 | January 2025 |
| NCT03008408 | Active, not recruiting | Phase 2 | A Phase II, Two-Arm Study of Everolimus and Letrozole, +/- Ribociclib (Lee011) in Patients With Advanced or Recurrent Endometrial Carcinoma | August 18, 2017 | August 31, 2028 |
| NCT04417621 | Active, not recruiting | Phase 2 | Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma | October 30, 2020 | September 30, 2024 |
| NCT02344472 | Active, not recruiting | Phase 3 | Detect V / CHEVENDO (Chemo vs. Endo) | September 2015 | January 31, 2025 |
| NCT03114527 | Active, not recruiting | Phase 2 | Phase II Trial of Ribociclib and Everolimus in Advanced Dedifferentiated Liposarcoma (DDL) and Leiomyosarcoma (LMS) | August 8, 2017 | December 2024 |
| NCT04213404 | Active, not recruiting | Phase 1 | Ribociclib and Spartalizumab in R/M HNSCC | March 13, 2020 | January 2025 |
| NCT03956654 | Active, not recruiting | A Phase IV Study to Collect Data on the Efficacy and Safety of RIBociclib in Older Women With Breastcancer | December 11, 2018 | June 30, 2024 | |
| NCT03333343 | Active, not recruiting | Phase 1 | Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC | January 29, 2018 | December 16, 2024 |
| NCT03671330 | Active, not recruiting | Phase 2 | Efficacy and Safety of Ribociclib in Pre- and Postmenopausal Chinese Women With HR Positive, HER2-negative, Advanced Breast Cancer. | August 29, 2018 | April 15, 2025 |
| NCT03673124 | Active, not recruiting | Phase 2 | Ribociclib and Letrozole Treatment in Ovarian Cancer | December 14, 2018 | December 31, 2024 |
| NCT05569187 | Completed | Ribociclib in Combination With Non-steroidal Aromatase Inhibitors in Patients With Advanced Breast Cancer | March 23, 2021 | October 29, 2021 | |
| NCT02732119 | Completed | Phase 1/Phase 2 | Study of Ribociclib With Everolimus + Exemestane in HR+ HER2- Locally Advanced/Metastatic Breast Cancer Post Progression on CDK 4/6 Inhibitor. | June 14, 2016 | February 25, 2020 |
| NCT05384119 | Completed | Phase 1/Phase 2 | Phase 1b/2 Study of TTI-101 in Combination for Patients With Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer | January 9, 2023 | April 25, 2024 |
| NCT02278120 | Completed | Phase 3 | Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer | November 20, 2014 | April 20, 2023 |
| NCT02292550 | Completed | Phase 1 | Study of Safety and Efficacy of LEE011 and Ceritinib in Patients With ALK-positive Non-small Cell Lung Cancer. | May 14, 2015 | September 26, 2018 |
| NCT03555877 | Completed | Phase 2 | Anti-hormonal Therapie With Ribociclib in HR-positive / HER2- Negative Metastatic Breast Cancer | March 15, 2018 | July 21, 2022 |
| NCT02941926 | Completed | Phase 3 | Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC | November 30, 2016 | November 9, 2022 |
| NCT02035813 | Completed | Phase 2 | DETECT IV - A Study in Patients With HER2-negative Metastatic Breast Cancer and Persisting HER2-negative Circulating Tumor Cells (CTCs). | January 2014 | January 10, 2024 |
| NCT03355794 | Completed | Phase 1 | A Study of Ribociclib and Everolimus Following Radiation Therapy in Children With Newly Diagnosed Non-biopsied Diffuse Pontine Gliomas (DIPG) and RB+ Biopsied DIPG and High Grade Gliomas (HGG) | November 14, 2017 | July 31, 2022 |
| NCT03009201 | Completed | Phase 1 | Ribociclib and Doxorubicin in Treating Patients With Metastatic or Advanced Soft Tissue Sarcomas That Cannot Be Removed by Surgery | March 10, 2017 | June 30, 2023 |
| NCT05153135 | Completed | Description of Treatment Patterns and Description and Comparison of Healthcare Resource Utilization and Costs of Women With Metastatic HR+/HER2- Breast Cancer Treated With CDK4/6 Inhibitors | May 8, 2020 | July 31, 2020 | |
| NCT03056833 | Completed | Phase 1 | Ribociclib (Ribociclib (LEE-011)) With Platinum-based Chemotherapy in Recurrent Platinum Sensitive Ovarian Cancer | June 10, 2017 | August 1, 2022 |
| NCT03078751 | Completed | Phase 2 | Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- High Risk Early Breast Cancer | June 20, 2017 | March 9, 2020 |
| NCT03387020 | Completed | Phase 1 | Ribociclib and Everolimus in Treating Children With Recurrent or Refractory Malignant Brain Tumors | January 13, 2018 | April 1, 2020 |
| NCT02657343 | Completed | Phase 1/Phase 2 | An Open-Label, Phase Ib/II Clinical Trial Of Cdk 4/6 Inhibitor, Ribociclib (Lee011), In Combination With Trastuzumab Or T-Dm1 For Advanced/Metastatic Her2-Positive Breast Cancer. | March 9, 2016 | June 30, 2022 |
| NCT02657928 | Completed | Phase 2 | Ribociclib and Letrozole in Treating Patients With Relapsed ER Positive Ovarian, Fallopian Tube, Primary Peritoneal, or Endometrial Cancer | July 8, 2016 | October 7, 2020 |
| NCT03477396 | Completed | Phase 2 | Ribociclib and Aromatase Inhibitor in Treating Older Participants With Hormone Receptor Positive Metastatic Breast Cancer | June 14, 2018 | June 5, 2023 |
| NCT03096847 | Completed | Phase 3 | Study for Women and Men With Hormone-receptor Positive Locally Advanced or Metastatic Breast Cancer | October 24, 2016 | February 6, 2020 |
| NCT04256941 | Completed | Phase 2 | Aromatase Inhibitor Therapy With or Without Fulvestrant for the Treatment of HR Positive Metastatic Breast Cancer With an ERS1 Activating Mutation, the INTERACT Study | May 31, 2019 | September 22, 2023 |
| NCT03434262 | Completed | Phase 1 | SJDAWN: St. Jude Children's Research Hospital Phase 1 Study Evaluating Molecularly-Driven Doublet Therapies for Children and Young Adults With Recurrent Brain Tumors | March 5, 2018 | May 24, 2024 |
| NCT03439046 | Completed | Phase 3 | Study of the Molecular Features of Postmenopausal Women With HR+ HER2-negative aBC on First-line Treatment With Ribociclib and Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant | February 2, 2018 | December 11, 2023 |
| NCT03834740 | Completed | Early Phase 1 | A Phase 0 /II Study of Ribociclib (LEE011) in Combination With Everolimus in Preoperative Recurrent High-Grade Glioma Patients Scheduled for Resection | December 21, 2018 | February 18, 2022 |
| NCT03839823 | Completed | Phase 2 | Study to Compare the Combination of Ribociclib Plus Goserelin Acetate With Hormonal Therapy Versus Combination Chemotherapy in Premenopausal or Perimenopausal Patients With Advanced or Metastatic Breast Cancer | February 25, 2019 | May 10, 2023 |
| NCT03237390 | Completed | Phase 1 | Ribociclib and Gemcitabine Hydrochloride in Treating Patients With Advanced or Metastatic Solid Tumors | January 4, 2018 | May 17, 2022 |
| NCT02420691 | Completed | Phase 2 | Ribociclib in Treating Patients With Advanced Neuroendocrine Tumors of Foregut Origin | August 25, 2015 | June 5, 2019 |
| NCT02422615 | Completed | Phase 3 | Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer. | June 9, 2015 | January 11, 2023 |
| NCT02494921 | Completed | Phase 1/Phase 2 | LEE011 (Ribociclib) in Combination With Docetaxel Plus Prednisone in mCRPC | November 20, 2015 | July 30, 2021 |
| NCT02555189 | Completed | Phase 1/Phase 2 | Enzalutamide With Ribociclib in Treating Patients With Metastatic Castrate-Resistant, Chemotherapy Naive Prostate Cancer That Retains Retinoblastoma Expression | December 1, 2015 | September 1, 2023 |
| NCT02586675 | Completed | Phase 1 | TEEL Study- Phase 1 Tamoxifen and Ribociclib (LEE011) in Advanced ER+ (HER2 Negative) Breast Cancer | February 23, 2016 | October 27, 2021 |
| NCT03248427 | Completed | Phase 2 | Neadjuvant Multi-agent Chemotherapy or Letrozole Plus Ribociclib in Luminal B/HER2-negative Breast Cancer. | July 13, 2017 | July 20, 2019 |
| NCT06377852 | Not yet recruiting | Phase 3 | The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study | October 28, 2024 | September 1, 2028 |
| NCT06380751 | Not yet recruiting | Phase 3 | 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 | April 18, 2024 | July 18, 2030 |
| NCT05843253 | Not yet recruiting | Phase 2 | Study of Ribociclib and Everolimus in HGG and DIPG | May 30, 2024 | May 30, 2034 |
| NCT05358249 | Recruiting | Phase 1/Phase 2 | Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation | October 24, 2022 | June 16, 2027 |
| NCT02813135 | Recruiting | Phase 1/Phase 2 | European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors | August 3, 2016 | August 2027 |
| NCT02925234 | Recruiting | Phase 2 | The Drug Rediscovery Protocol (DRUP Trial) | August 2016 | December 2027 |
| NCT03090165 | Recruiting | Phase 1/Phase 2 | Ribociclib and Bicalutamide in AR+ TNBC | May 7, 2018 | September 2024 |
| NCT03285412 | Recruiting | Phase 2 | CDK 4/6 Inhibitor, Ribociclib, With Adjuvant Endocrine Therapy for ER-positive Breast Cancer | December 12, 2017 | October 2026 |
| NCT03424005 | Recruiting | Phase 1/Phase 2 | A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer | April 2, 2018 | May 3, 2026 |
| NCT05161195 | Recruiting | Phase 4 | Roll-over Study to Allow Continued Access to Ribociclib | July 7, 2022 | March 26, 2030 |
| NCT05252416 | Recruiting | Phase 1/Phase 2 | (VELA) Study of BLU-222 in Advanced Solid Tumors | April 7, 2022 | September 30, 2026 |
| NCT05319873 | Recruiting | Phase 1/Phase 2 | Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2 Positive Breast Cancer | April 7, 2022 | April 1, 2026 |
| NCT05429502 | Recruiting | Phase 1/Phase 2 | 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 | December 27, 2022 | January 29, 2029 |
| NCT05452213 | Recruiting | Phase 4 | Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients | October 12, 2022 | October 2026 |
| NCT05467891 | Recruiting | Phase 2 | Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer | September 13, 2022 | December 2027 |
| NCT05508906 | Recruiting | Phase 1 | Phase 1b Combo w/ Ribociclib and Alpelisib | August 31, 2022 | August 31, 2024 |
| NCT05563220 | Recruiting | Phase 1/Phase 2 | Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer | January 24, 2023 | August 31, 2026 |
| NCT05573555 | Recruiting | Phase 1/Phase 2 | 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) | March 1, 2023 | December 14, 2026 |
| NCT05625087 | Recruiting | Phase 2 | 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 | October 19, 2023 | June 2030 |
| NCT05766410 | Recruiting | Phase 2 | A Randomized Study Comparing the Immune Modulation Effect of Ribociclib, Palbociclib, and Abemaciclib in ER+/HER2- EBC | September 16, 2022 | September 30, 2026 |
| NCT05867251 | Recruiting | Phase 1/Phase 2 | Study of AVZO-021 in Patients With Advanced Solid Tumors | August 30, 2023 | January 31, 2030 |
| NCT05870579 | Recruiting | Phase 1 | [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer | November 13, 2023 | January 18, 2030 |
| NCT05900206 | Recruiting | Phase 2 | Trastuzumab Deruxtecan Versus Standard Neoadjuvant Treatment for HER2-positive Breast Cancer | October 26, 2023 | April 30, 2032 |
| NCT05996107 | Recruiting | Phase 1 | Study of Ribociclib Administered Concurrently With Postoperative Radiation Therapy in Patients With High-Risk, Node Positive, HR+/HER2- Breast Cancer | February 27, 2024 | March 1, 2030 |
| NCT06065748 | Recruiting | Phase 3 | 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) | December 11, 2023 | December 30, 2028 |
| NCT06075758 | Recruiting | A Study of Ribociclib in Combination With Hormonal Therapy in HR+/HER2- Advanced or Metastatic Breast Cancer | March 7, 2024 | November 30, 2024 | |
| NCT06148506 | Recruiting | A Prospective NIS to Evaluate the Clinical Outcomes of Risarg® (Ribociclib) Combined With Endocrine Therapy or Chemotherapy in Patients With HR+HER2 - aBC in Routine Clinical Practice in the Russia | December 28, 2023 | June 30, 2027 | |
| NCT06188520 | Recruiting | Phase 1/Phase 2 | 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 | December 5, 2023 | June 18, 2025 |
| NCT06409390 | Recruiting | Early Phase 1 | Sequential Therapies Modeled on Evolutionary Dynamics for Breast Cancer | April 26, 2024 | April 2027 |
| NCT04116541 | Recruiting | Phase 2 | A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors. | January 28, 2020 | November 2026 |
| NCT04315233 | Recruiting | Phase 1 | Ribociclib&Belinostat In Patients w Metastatic Triple Neg Breast Cancer & Recurrent Ovarian Cancer w Response Prediction By Genomics | May 3, 2021 | August 2026 |
| NCT04802759 | Recruiting | Phase 1/Phase 2 | A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer | June 20, 2021 | October 31, 2026 |
| NCT04862663 | Recruiting | Phase 3 | Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292) | May 10, 2021 | August 14, 2029 |
| NCT04943497 | Recruiting | A Prospective Observational Study to Describe Clinical Outcomes, Treatment Patterns, Patients Characteristics Among Patients With HR+/HER2- Advanced BC Initiating Treatment With Risarg®, Piqray®, Endocrine Therapy or Chemotherapy in Routine Clinical Practice in Russia | July 27, 2021 | June 30, 2025 | |
| NCT04964934 | Recruiting | Phase 3 | Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6) | June 30, 2021 | November 26, 2027 |
| NCT05827081 | Suspended | Phase 3 | Phase IIIb Study of Ribociclib + ET in Early Breast Cancer | February 28, 2024 | September 20, 2030 |
| NCT05038631 | Temporarily not available | Managed Access Programs for LEE011, Ribociclib | |||
| NCT04000529 | Terminated | Phase 1 | Phase Ib Study of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies | July 30, 2019 | January 15, 2024 |
| NCT02703571 | Terminated | Phase 1 | Study of Safety and Efficacy of Ribociclib and Trametinib in Patients With Metastatic or Advanced Solid Tumors | June 29, 2016 | September 24, 2019 |
| NCT03179956 | Terminated | Early Phase 1 | Impact of Ribociclib on Head and Neck Squamous Cell Cancer | April 2, 2018 | January 10, 2019 |
| NCT02974725 | Terminated | Phase 1 | A Phase Ib Study of LXH254-centric Combinations in NSCLC or Melanoma | February 24, 2017 | April 24, 2024 |
| NCT04801966 | Terminated | N/A | Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study | September 23, 2021 | December 30, 2022 |
| NCT03294694 | Terminated | Phase 1 | Ribociclib + PDR001 in Breast Cancer and Ovarian Cancer | November 8, 2017 | October 14, 2020 |
| NCT04657679 | Terminated | Phase 4 | Pharmacokinetics and Pharmacogenomics of Ribociclib in Race-based Cohorts | May 20, 2021 | October 30, 2023 |
| NCT03905343 | Terminated | Phase 3 | Ribociclib-endocrine Combination Therapy Versus Chemotherapy as 1st Line in Visceral mBC | June 25, 2019 | April 15, 2021 |
| NCT02780128 | Terminated | Phase 1 | Next Generation Personalized Neuroblastoma Therapy | July 2016 | August 2022 |
| NCT02414724 | Terminated | Phase 1 | Ribociclib and Gemcitabine Hydrochloride in Treating Patients With Advanced Solid Tumors or Lymphoma | May 2015 | June 2016 |
| NCT02607124 | Terminated | Phase 1/Phase 2 | A Phase I/II Study of Ribociclib,a CDK4/6 Inhibitor, Following Radiation Therapy | April 2016 | August 2018 |
| NCT03050398 | Terminated | Phase 3 | A Companion Sample Collection Protocol to Support the Discovery of Breast Cancer Aberrations With Treatment of CDK4/6 Therapy/LEE011/Ribociclib | June 7, 2017 | March 8, 2019 |
| NCT03096912 | Unknown status | Phase 2 | A Study Assessing Efficacy & Safety of Ribociclib in Patients With Advanced Well/Dedifferentiated Liposarcoma | July 2016 | April 2020 |
| NCT02345824 | Unknown status | Phase 1 | Early-Phase Study to Assess Inhibitor Ribociclib in Patients With Recurrent Glioblastoma or Anaplastic Glioma | March 2016 | January 2020 |
| NCT04852081 | Unknown status | Analysis of Therapy Sequence in Women With HR+, HER2 - mBC in Moscow: A Multicenter Retrospective Observational Study. | January 1, 2021 | December 1, 2021 | |
| NCT02571829 | Unknown status | Phase 2 | A Phase II Study Assessing Efficacy & Safety of Ribociclib in Patients With Advanced Well/Dedifferentiated Liposarcoma | May 2016 | October 2017 |
| NCT04585724 | Withdrawn | Phase 1 | Stereotactic Radiosurgery With Abemaciclib, Ribociclib, or Palbociclib in Treating Patients With Hormone Receptor Positive Breast Cancer With Brain Metastases | June 12, 2020 | September 13, 2021 |
| NCT03081234 | Withdrawn | Phase 3 | Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- Intermediate Risk Early Breast Cancer | March 31, 2018 | November 17, 2025 |