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ClinicalTrials.gov public records Last synced Oct 16, 2026, 4:11 PM EDT

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Showing 1–24 of 138 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: LEE011 Clear all
Active, not recruiting Phase 2 Interventional

CDK 4/6 Inhibitor, Ribociclib, With Adjuvant Endocrine Therapy for ER-positive Breast Cancer

NCT03285412
View directory record Official record
Conditions
Breast Cancer
Interventions
Ribociclib, Endocrine therapy
Drug · Other
Lead sponsor
Massachusetts General Hospital
Other
Eligibility
18 Years and older · Female only
Enrollment
120 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2026
U.S. locations
3
States / cities
Boston, Massachusetts • Danvers, Massachusetts
Source: ClinicalTrials.gov public record
Updated Dec 22, 2025 · Synced Oct 16, 2026, 4:11 PM EDT
Completed Phase 1 Interventional Results available

Ribociclib and Everolimus in Treating Children With Recurrent or Refractory Malignant Brain Tumors

NCT03387020
View directory record Official record
Conditions
CNS Embryonal Tumor, Not Otherwise Specified, Malignant Glioma, Recurrent Atypical Teratoid/Rhabdoid Tumor, Recurrent Childhood Ependymoma, Recurrent Diffuse Intrinsic Pontine Glioma, Recurrent Medulloblastoma, Refractory Diffuse Intrinsic Pontine Glioma
Interventions
Everolimus, Laboratory Biomarker Analysis, Pharmacological Study, Ribociclib
Drug · Other
Lead sponsor
Pediatric Brain Tumor Consortium
Network
Eligibility
1 Year to 21 Years
Enrollment
22 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
12
States / cities
Los Angeles, California • Palo Alto, California • Aurora, Colorado + 8 more
Source: ClinicalTrials.gov public record
Updated Aug 27, 2021 · Synced Oct 16, 2026, 4:11 PM EDT
Recruiting Not applicable Interventional

Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer

NCT07214532
View directory record Official record
Conditions
Breast Neoplasms, Carcinoma, Ductal, Breast, Receptors, Estrogen (for ER-positive Requirement)
Interventions
ctDNA-Guided Treatment Strategy
Device
Lead sponsor
Natera, Inc.
Industry
Eligibility
18 Years and older
Enrollment
725 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2037
U.S. locations
49
States / cities
Phoenix, Arizona • Scottsdale, Arizona • Tucson, Arizona + 44 more
Source: ClinicalTrials.gov public record
Updated Sep 23, 2026 · Synced Oct 16, 2026, 4:11 PM EDT
Completed Phase 1 Interventional

Ribociclib (Ribociclib (LEE-011)) With Platinum-based Chemotherapy in Recurrent Platinum Sensitive Ovarian Cancer

NCT03056833
View directory record Official record
Conditions
Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Carcinoma
Interventions
ribociclib, Paclitaxel, Carboplatin
Drug
Lead sponsor
Ronald Buckanovich
Other
Eligibility
18 Years and older · Female only
Enrollment
35 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2022
U.S. locations
8
States / cities
Ann Arbor, Michigan • Bethel Park, Pennsylvania • Greensburg, Pennsylvania + 4 more
Source: ClinicalTrials.gov public record
Updated Sep 7, 2022 · Synced Oct 16, 2026, 4:11 PM EDT
Terminated Early Phase 1 Interventional

Impact of Ribociclib on Head and Neck Squamous Cell Cancer

NCT03179956
View directory record Official record
Conditions
Squamous Cell Carcinoma of the Head and Neck
Interventions
Ribociclib
Drug
Lead sponsor
Fox Chase Cancer Center
Other
Eligibility
18 Years and older
Enrollment
1 participant
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2019
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Feb 25, 2019 · Synced Oct 16, 2026, 4:11 PM EDT
Completed Phase 1Phase 2 Interventional Results available

LEE011 Plus Everolimus in Patients With Metastatic Pancreatic Adenocarcinoma Refractory to Chemotherapy

NCT02985125
View directory record Official record
Conditions
Metastatic Pancreatic Adenocarcinoma
Interventions
LEE011, Everolimus
Drug
Lead sponsor
Georgetown University
Other
Eligibility
18 Years and older
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2020
U.S. locations
1
States / cities
Washington D.C., District of Columbia
Source: ClinicalTrials.gov public record
Updated Apr 7, 2026 · Synced Oct 16, 2026, 4:11 PM EDT
Completed Phase 3 Interventional Results available

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

NCT02941926
View directory record Official record
Conditions
Breast Cancer
Interventions
Ribociclib, Letrozole, Goserelin, Leuprolide
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
3,246 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2022
U.S. locations
71
States / cities
Anchorage, Alaska • Chandler, Arizona • Phoenix, Arizona + 66 more
Source: ClinicalTrials.gov public record
Updated Oct 24, 2023 · Synced Oct 16, 2026, 4:11 PM EDT
Completed No phase listed Observational

Emulation of the MONALEESA-2 Trial Using Specialty Oncology Electronic Health Records Databases

NCT07274709
View directory record Official record
Conditions
Advanced Breast Cancer
Interventions
Initiation of ribociclib, Initiation of letrozole
Drug
Lead sponsor
Shirley Vichy Wang
Other
Eligibility
18 Years and older · Female only
Enrollment
2,495 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2026
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated May 12, 2026 · Synced Oct 16, 2026, 4:11 PM EDT
Not listed Phase 1 Interventional

Early-Phase Study to Assess Inhibitor Ribociclib in Patients With Recurrent Glioblastoma or Anaplastic Glioma

NCT02345824
View directory record Official record
Conditions
Glioblastoma, Glioma
Interventions
Ribociclib
Drug
Lead sponsor
University of Virginia
Other
Eligibility
18 Years to 85 Years
Enrollment
3 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2020
U.S. locations
1
States / cities
Charlottesville, Virginia
Source: ClinicalTrials.gov public record
Updated Jun 7, 2018 · Synced Oct 16, 2026, 4:11 PM EDT
Terminated Phase 2 Interventional Results available

A Pharmacodynamics Pre-surgical Study of LEE011 in Early Breast Cancer Patients (MONALEESA-1)

NCT01919229
View directory record Official record
Conditions
Early Breast Cancer
Interventions
LEE011 (ribociclib), letrozole
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older · Female only
Enrollment
14 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
4
States / cities
Fayetteville, Arkansas • Los Angeles, California • Boston, Massachusetts + 1 more
Source: ClinicalTrials.gov public record
Updated Jan 1, 2016 · Synced Oct 16, 2026, 4:11 PM EDT
Recruiting Phase 4 Interventional

The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib for Participants in Prior Clinical Trials

NCT05203172
View directory record Official record
Conditions
Solid Tumors
Interventions
Binimetinib, Encorafenib, Vemurafenib, Ribociclib, Cetuximab, Pembrolizumab, Nivolumab, 5-Fluorouracil, Leucovorin, Oxaliplatin, Irinotecan, Capecitabine, Bevacizumab
Drug · Biological
Lead sponsor
Pfizer
Industry
Eligibility
18 Years and older
Enrollment
210 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2032
U.S. locations
18
States / cities
Phoenix, Arizona • Atlanta, Georgia • Boston, Massachusetts + 5 more
Source: ClinicalTrials.gov public record
Updated Oct 2, 2026 · Synced Oct 16, 2026, 4:11 PM EDT
Completed Phase 2 Interventional Results available

Ribociclib and Letrozole in Treating Patients With Relapsed ER Positive Ovarian, Fallopian Tube, Primary Peritoneal, or Endometrial Cancer

NCT02657928
View directory record Official record
Conditions
Estrogen Receptor Positive, Postmenopausal, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma, Recurrent Uterine Corpus Carcinoma
Interventions
Laboratory Biomarker Analysis, Letrozole, Ribociclib
Other · Drug
Lead sponsor
Mayo Clinic
Other
Eligibility
18 Years and older · Female only
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2020
U.S. locations
3
States / cities
Scottsdale, Arizona • Jacksonville, Florida • Rochester, Minnesota
Source: ClinicalTrials.gov public record
Updated Oct 26, 2021 · Synced Oct 16, 2026, 4:11 PM EDT
Terminated Phase 3 Interventional

Ribociclib vs. Palbociclib in Patients With Advanced Breast Cancer Within the HER2-Enriched Intrinsic Subtype

NCT05207709
View directory record Official record
Conditions
Metastatic Breast Cancer
Interventions
Ribociclib + Letrozole OR Fulvestrant, Palbociclib + Letrozole OR Fulvestrant, Paclitaxel +/- Tislelizumab
Drug
Lead sponsor
SOLTI Breast Cancer Research Group
Other
Eligibility
18 Years and older
Enrollment
61 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2026
U.S. locations
26
States / cities
Clearwater, Florida • Coral Gables, Florida • Hollywood, Florida + 22 more
Source: ClinicalTrials.gov public record
Updated Jun 25, 2026 · Synced Oct 16, 2026, 4:11 PM EDT
Completed Phase 2 Interventional Results available

LGX818 and MEK162 in Combination With a Third Agent (BKM120, LEE011, BGJ398 or INC280) in Advanced BRAF Melanoma

NCT02159066
View directory record Official record
Conditions
Melanoma
Interventions
LGX818, MEK162, LEE011, BGJ398, BKM120, INC280
Drug
Lead sponsor
Pfizer
Industry
Eligibility
18 Years and older
Enrollment
158 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2023
U.S. locations
17
States / cities
Los Angeles, California • New York, New York • Portland, Oregon + 1 more
Source: ClinicalTrials.gov public record
Updated Mar 5, 2024 · Synced Oct 16, 2026, 4:11 PM EDT
Completed Phase 2 Interventional Results available

Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- High Risk Early Breast Cancer

NCT03078751
View directory record Official record
Conditions
Breast Cancer
Interventions
Ribociclib, Adjuvant endocrine therapy, Placebo
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
54 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2020
U.S. locations
33
States / cities
Tucson, Arizona • Fayetteville, Arkansas • Bakersfield, California + 28 more
Source: ClinicalTrials.gov public record
Updated Oct 11, 2021 · Synced Oct 16, 2026, 4:11 PM EDT
Active, not recruiting Phase 2 Interventional

Phase II Trial of Ribociclib and Everolimus in Advanced Dedifferentiated Liposarcoma (DDL) and Leiomyosarcoma (LMS)

NCT03114527
View directory record Official record
Conditions
Soft Tissue Sarcoma
Interventions
Ribociclib, Everolimus
Drug
Lead sponsor
Fox Chase Cancer Center
Other
Eligibility
18 Years and older
Enrollment
48 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2026
U.S. locations
2
States / cities
Boston, Massachusetts • Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated May 22, 2026 · Synced Oct 16, 2026, 4:11 PM EDT
Recruiting Phase 3 Interventional

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

NCT07391774
View directory record Official record
Conditions
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Estrogen Receptor-Positive Breast Carcinoma, HER2-Negative Breast Carcinoma
Interventions
Anastrozole, Biospecimen Collection, Bone Scan, Chemotherapy, Computed Tomography, Exemestane, Letrozole, Oncotype DX Breast Cancer Assay, Positron Emission Tomography, Ribociclib Succinate
Drug · Procedure
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
1,978 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2029
U.S. locations
203
States / cities
Jonesboro, Arkansas • Auburn, California • Berkeley, California + 169 more
Source: ClinicalTrials.gov public record
Updated Oct 16, 2026 · Synced Oct 16, 2026, 4:11 PM EDT
Completed Phase 1 Interventional

Phase Ib Trial of LEE011 With Everolimus (RAD001) and Exemestane in the Treatment of Hormone Receptor Positive HER2 Negative Advanced Breast Cancer

NCT01857193
View directory record Official record
Conditions
Breast Cancer
Interventions
ribociclib (LEE011), Exemestane, Everolimus (RAD001)
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older · Female only
Enrollment
132 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2020
U.S. locations
8
States / cities
Fayetteville, Arkansas • Miami, Florida • Boston, Massachusetts + 5 more
Source: ClinicalTrials.gov public record
Updated Apr 13, 2021 · Synced Oct 16, 2026, 4:11 PM EDT
Recruiting Phase 3 Interventional

Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation

NCT05696626
View directory record Official record
Conditions
Metastatic Breast Cancer
Interventions
Lasofoxifene in combination with abemaciclib, Fulvestrant in combination with abemaciclib
Drug
Lead sponsor
LeonaBio
Industry
Eligibility
18 Years and older
Enrollment
600 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2028
U.S. locations
36
States / cities
Scottsdale, Arizona • Tucson, Arizona • Santa Rosa, California + 25 more
Source: ClinicalTrials.gov public record
Updated Jun 22, 2026 · Synced Oct 16, 2026, 4:11 PM EDT
Active, not recruiting Phase 1Phase 2 Interventional

Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer

NCT01872260
View directory record Official record
Conditions
Breast Cancer
Interventions
LEE011, Letrozole, BYL719
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 100 Years · Female only
Enrollment
259 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2027
U.S. locations
10
States / cities
San Diego, California • San Francisco, California • Tampa, Florida + 5 more
Source: ClinicalTrials.gov public record
Updated Sep 18, 2026 · Synced Oct 16, 2026, 4:11 PM EDT
Active, not recruiting Phase 1Phase 2 Interventional

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)

NCT05573555
View directory record Official record
Conditions
Breast Cancer
Interventions
ARV-471, Ribociclib
Drug
Lead sponsor
Pfizer
Industry
Eligibility
18 Years and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2026
U.S. locations
20
States / cities
Palo Alto, California • San Francisco, California • Tampa, Florida + 7 more
Source: ClinicalTrials.gov public record
Updated Mar 9, 2026 · Synced Oct 16, 2026, 4:11 PM EDT
Terminated Phase 1 Interventional

Ribociclib and Gemcitabine Hydrochloride in Treating Patients With Advanced Solid Tumors or Lymphoma

NCT02414724
View directory record Official record
Conditions
Lymphoma, Solid Neoplasm
Interventions
Gemcitabine Hydrochloride, Laboratory Biomarker Analysis, Pharmacological Study, Ribociclib
Drug · Other
Lead sponsor
Roswell Park Cancer Institute
Other
Eligibility
18 Years and older
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
1
States / cities
Buffalo, New York
Source: ClinicalTrials.gov public record
Updated Jul 25, 2022 · Synced Oct 16, 2026, 4:11 PM EDT
Completed Phase 1 Interventional

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)

NCT03355794
View directory record Official record
Conditions
Diffuse Intrinsic Pontine Glioma, Malignant Glioma of Brain, High Grade Glioma, Bithalamic High Grade Glioma, Brainstem Glioma, Glioblastoma, Anaplastic Astrocytoma
Interventions
ribociclib, Everolimus
Drug
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Other
Eligibility
12 Months to 30 Years
Enrollment
19 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2022
U.S. locations
7
States / cities
Washington D.C., District of Columbia • Chicago, Illinois • Charlotte, North Carolina + 4 more
Source: ClinicalTrials.gov public record
Updated Jan 13, 2023 · Synced Oct 16, 2026, 4:11 PM EDT
Terminated Phase 1 Interventional

Ribociclib + PDR001 in Breast Cancer and Ovarian Cancer

NCT03294694
View directory record Official record
Conditions
Metastatic Hormone-Receptor-Positive (HR+) Breast Cancer, HER2-Negative Breast Cancer, Metastatic Epithelial Ovarian Cancer
Interventions
Ribociclib, PDR001, Fulvestrant
Drug
Lead sponsor
Dana-Farber Cancer Institute
Other
Eligibility
18 Years and older
Enrollment
33 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2020
U.S. locations
3
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated May 31, 2025 · Synced Oct 16, 2026, 4:11 PM EDT