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Ribociclib Clinical Trials

39 actively recruiting trials across 20 locations

No change since May 2026

Also known as: CDK4/6 inhibitor, Closed cohort, KISQALI®, Kisqali, Kisqali® +3 more

Pipeline

Phase 1: 8Phase 2: 10Phase 3: 8Phase 4: 1Phase 1/2: 7

Top Sponsors

  • Novartis Pharmaceuticals6
  • Hoffmann-La Roche4
  • AstraZeneca3
  • Olema Pharmaceuticals, Inc.2
  • Eli Lilly and Company2

Indications

  • Cancer39
  • Breast Cancer35
  • Metastatic Breast Cancer7
  • Hormone Receptor Positive Breast Cancer4
  • HR+/HER2- Breast Cancer3

Other13 trials

A Randomized Study Comparing the Immune Modulation Effect of Ribociclib, Palbociclib, and Abemaciclib in ER+/HER2- EBC
Phase 2
A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors.
Phase 2
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
Phase 3
Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients
Phase 4
Efficacy and Safety of Camizestrant Plus Ribociclib in Patients With Breast Cancer
Phase 2
European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors
Phase 1/2
Implementation Study to Describe and Compare Retention Rate and Adherence to Adjuvant Therapy With Ribociclib With and Without Usage of Mobile Application in Patients With HR+ HER2-negative Stage II and III Breast Cancer in Real-world Practice
Non-interventional Study to Assess the Effectiveness and Safety of Ribociclib in the Adjuvant Therapy of Hormone Receptor Positive (HR+) HER2-negative Stage II and III Breast Cancer in Real Clinical Practice in Russia
Predicting clinicAL outcoMes During First-line CDK4/6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study
RWE Non-Interventional Prospective Study of Ribociclib Effectiveness and Safety in Patients With HR+/HER2- Early Breast Cancer in Saudi Arabia
Ribociclib in Combination With Adjuvant Endocrine Therapy for Patients With Early High-risk HR+HER2- Breast Cancer
The Drug Rediscovery Protocol (DRUP Trial)
Phase 2
Trastuzumab Deruxtecan Versus Standard Neoadjuvant Treatment for HER2-positive Breast Cancer
Phase 2

Duarte, California3 trials

A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer

City of Hope

Phase 1/2
Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

City of Hope Comprehensive Cancer Center

Phase 1
Study of INCB123667 in Subjects With Advanced Solid Tumors

City of Hope Medical Center

Phase 1

Los Angeles, California3 trials

First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors

Ellison Clinic at Saint John's

Phase 1/2
Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and Other Advanced Solid Tumors

University of California LA

Phase 1/2
[177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer

UCLA Jonsson Comp Cancer Center

Phase 1

Birmingham, Alabama2 trials

Phase IIIb Study of Ribociclib + ET in Early Breast Cancer

Central Alabama Research

Phase 3
Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer

University of Alabama at Birmingham

Phase 2

Gilbert, Arizona2 trials

Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer

Banner MD Anderson Cancer Center

Phase 1
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

Research Site

Phase 3

Daphne, Alabama1 trial

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)

Southern Cancer Center

Phase 3

Dothan, Alabama1 trial

Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer

Dothan Hematology and Oncology

Phase 1/2

Anchorage, Alaska1 trial

A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)

Alaska Oncology and Hematology

Phase 3

Chandler, Arizona1 trial

The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study

Ironwood Cancer & Research Centers

Phase 3

Tucson, Arizona1 trial

Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)

Research Site

Phase 3

Hot Springs, Arkansas1 trial

Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer

Clinical Trial Site

Phase 3

Encinitas, California1 trial

First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer

California Cancer Associates for Research and Excellence

Phase 1

Orange, California1 trial

A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer

Community Clinical Trials

Phase 2

Aurora, Colorado1 trial

Study of Ribociclib and Everolimus in HGG and DIPG or Ribociclib and Temozolomide in DHG, H3G34-mutant

Children's Hospital Colorado

Phase 2

New Haven, Connecticut1 trial

Study of AVZO-021 in Patients With Advanced Solid Tumors

Yale Cancer Center

Phase 1/2

Tampa, Florida1 trial

Sequential Therapies Modeled on Evolutionary Dynamics for Breast Cancer

Moffitt Cancer Center

Phase 2

Chicago, Illinois1 trial

A Study to Evaluate the Safety and Tolerability of TOS-358 in Women With HR+ HER2- Breast Cancer

Northwestern Memorial Hospital

Phase 1

Ann Arbor, Michigan1 trial

Study of Ribociclib Administered Concurrently With Postoperative Radiation Therapy in Patients With High-Risk, HR+/HER2- Breast Cancer

University of Michigan

Phase 1

Marshall, Minnesota1 trial

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

Avera Cancer Institute - Marshall

Phase 2

St Louis, Missouri1 trial

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

Research Site

Phase 1/2

Salt Lake City, Utah1 trial

Ribociclib&Belinostat In Patients w Metastatic Triple Neg Breast Cancer & Recurrent Ovarian Cancer w Response Prediction By Genomics

Huntsman Cancer Institute

Phase 1

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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