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Compound · clinical trials

Ribociclib clinical trials

Also listed in trial records as RO7072612, LEE011
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 38 trials in our USA, UK, China, India and Ireland registers that name Ribociclib as an intervention. Synced 25 Sep 2026
38Current trials
20Recruiting now
18Lead sponsors
5Country registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 โ€” Top 14 finalist
Compiled from ClinicalTrials.gov registry records ยท Last verified ยท Editorial standards
At a glance

Ribociclib is named as an intervention in 38 current clinical trials in our USA, UK, China, India and Ireland registers. 20 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Novartis Pharmaceuticals (9). The most-studied condition is Breast Cancer.

Ribociclib also has an approved-drug profile on this site (FDA label data): Kisqali (Ribociclib) →

Trials by status

  • Recruiting2053%
  • Not yet open13%
  • Active, closed1745%

Trials by phase

  • Phase 31334%
  • Phase 1/21129%
  • Phase 1616%
  • Phase 2513%
  • Observational25%
  • Phase 413%
01

Clinical trials of Ribociclib

38 trials
StudyPhaseStatusLead sponsorRegisters
Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
NCT05827081 · Early Breast Cancer
Phase 3 Recruiting Novartis Pharmaceuticals USA, India, China
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
NCT06380751 · ClinicalTrials.gov ↗ · Advanced Breast Cancer
Phase 3 Recruiting AstraZeneca UK, USA, India, China
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)
NCT06757634 · ClinicalTrials.gov ↗ · Breast Cancer
Phase 3 Recruiting Celcuity Inc USA, China
Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
NCT07085767 · ClinicalTrials.gov ↗ · Breast Cancer, Locally Advanced Breast Cancer, Metastatic Breast Cancer
Phase 3 Recruiting Olema Pharmaceuticals, Inc. UK, USA
A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)
NCT07174336 · Breast Neoplasms, Neoplasm Metastasis
Phase 3 Recruiting Eli Lilly and Company Ireland, UK, USA, China
Ribociclib in Hormone Receptor-positive, HER2-negative Early Breast Cancer With Residual Disease After Neoadjuvant Chemotherapy
NCT07400523 · ClinicalTrials.gov ↗ · Breast Cancer
Phase 3 Recruiting Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University China
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
NCT07492641 · ClinicalTrials.gov ↗ · HR+/HER2- Breast Cancer
Phase 3 Recruiting BeOne Medicines UK, USA, China
A Phase IIIb Study to Evaluate Camizestrant Plus Ribociclib in ER-positive, HER2-negative Advanced Breast Cancer
NCT07647328 · ClinicalTrials.gov ↗ · ER-Positive HER2-Negative Breast Cancer
Phase 3 Recruiting AstraZeneca USA
A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer
NCT07054190 · ClinicalTrials.gov ↗ · Breast Cancer
Phase 2 Recruiting Hoffmann-La Roche USA
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
NCT07405801 · ClinicalTrials.gov ↗ · Breast Cancer
Phase 2 Recruiting Hoffmann-La Roche UK, USA
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
NCT03424005 · Metastatic Breast Cancer
Phase 1/2 Recruiting Hoffmann-La Roche UK, USA
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer
NCT04802759 · ClinicalTrials.gov ↗ · Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer
Phase 1/2 Recruiting Hoffmann-La Roche USA
First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
NCT05768139 · ClinicalTrials.gov ↗ · Breast Cancer, Solid Tumors, Adult
Phase 1/2 Recruiting Eli Lilly and Company Ireland, USA
Study of AVZO-021 in Patients With Advanced Solid Tumors
NCT05867251 · Advanced Solid Tumor, HR+/HER2- Breast Cancer, HR+, HER2-, Advanced Breast Cancer
Phase 1/2 Recruiting Avenzo Therapeutics, Inc. USA
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
NCT06188520 · ClinicalTrials.gov ↗ · ER+ HER2- Advanced Breast Cancer, High-grade Serous Ovarian Cancer (HGSOC)
Phase 1/2 Recruiting AstraZeneca UK, USA
Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and in Patients With Other Advanced Solid Tumors
NCT06726148 · ClinicalTrials.gov ↗ · Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors, Extensive-stage Small Cell Lung Cancer
Phase 1/2 Recruiting Novartis Pharmaceuticals UK, USA, China
A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC
NCT07002177 · ClinicalTrials.gov ↗ · Metastatic Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II
Phase 1/2 Recruiting Forward Pharmaceuticals Co., Ltd. China
First-in-Human Study of Mutant-selective PI3Kฮฑ Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or Advanced Breast Cancer
NCT05216432 · ClinicalTrials.gov ↗ · PIK3CA Mutation, Solid Tumor, Adult, HER2-negative Breast Cancer
Phase 1 Recruiting Relay Therapeutics, Inc. USA
Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors
NCT06625775 · ClinicalTrials.gov ↗ · Solid Tumor, Adult, Metastatic Breast Cancer, Advanced Breast Cancer
Phase 1 Recruiting TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) USA
Ribociclib in Combination With Adjuvant Endocrine Therapy for Patients With Early High-risk HR+HER2- Breast Cancer
NCT06587789 · ClinicalTrials.gov ↗ · Breast Cancer
Observational Recruiting Second Affiliated Hospital, Zhejiang University, School of Medicine China
ctDNA-Guided Chemotherapy Omission With Ribociclib Plus Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer
NCT07423611 · ClinicalTrials.gov ↗ · Breast Cancer
Phase 2 Not yet open Fudan University China
Roll-over Study to Allow Continued Access to Ribociclib
NCT05161195 · Metastatic Breast Cancer
Phase 4 Active, closed Novartis Pharmaceuticals USA, India, China
A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer
NCT03701334 · ClinicalTrials.gov ↗ · Early Breast Cancer
Phase 3 Active, closed Novartis Pharmaceuticals Ireland, UK, USA, China
Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)
NCT04862663 · ClinicalTrials.gov ↗ · Locally Advanced (Inoperable) or Metastatic Breast Cancer
Phase 3 Active, closed AstraZeneca UK, USA, India, China
Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)
NCT04964934 · ClinicalTrials.gov ↗ · ER-Positive HER2-Negative Breast Cancer
Phase 3 Active, closed AstraZeneca UK, USA
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)
NCT06065748 · ClinicalTrials.gov ↗ · Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer
Phase 3 Active, closed Hoffmann-La Roche USA, India, China
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
NCT06760637 · ClinicalTrials.gov ↗ · Breast Cancer
Phase 3 Active, closed Pfizer Ireland, UK, USA, India, China
Ribociclib (LEE011) Rollover Study for Continued Access
NCT02934568 · ClinicalTrials.gov ↗ · Continued Access to Study Treatment(s), Cancers With a Mass, Bulky Tumor, Nodule, Lump, Advanced Cancer, Advanced Solid Tumors, Advanced Solid Malignancies
Phase 2 Active, closed Novartis Pharmaceuticals USA
Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma
NCT04417621 · ClinicalTrials.gov ↗ · Melanoma
Phase 2 Active, closed Novartis Pharmaceuticals UK, USA
Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer
NCT01872260 · ClinicalTrials.gov ↗ · Breast Cancer
Phase 1/2 Active, closed Novartis Pharmaceuticals UK, USA
Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
NCT05358249 · ClinicalTrials.gov ↗ · KRAS G12C Mutant Solid Tumors, Carcinoma, Non-Small Cell Lung, Carcinoma, Non-Small-Cell Lung
Phase 1/2 Active, closed Novartis Pharmaceuticals USA
Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer
NCT05563220 · ClinicalTrials.gov ↗ · Breast Cancer, Metastatic Breast Cancer
Phase 1/2 Active, closed Stemline Therapeutics, Inc. UK, USA
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 · ClinicalTrials.gov ↗ · Breast Cancer
Phase 1/2 Active, closed Pfizer USA
Study of INCB123667 in Subjects With Advanced Solid Tumors
NCT05238922 · ClinicalTrials.gov ↗ · Solid Tumors
Phase 1 Active, closed Incyte Corporation UK, USA
Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer
NCT05508906 · ClinicalTrials.gov ↗ · Metastatic Breast Cancer, ER-positive Breast Cancer, HER2-negative Breast Cancer
Phase 1 Active, closed Olema Pharmaceuticals, Inc. USA
[177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer
NCT05870579 · ClinicalTrials.gov ↗ · Breast Cancer
Phase 1 Active, closed Novartis Pharmaceuticals USA, China
First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer
NCT06239467 · Advanced Cancer, Breast Cancer, Advanced Solid Tumors
Phase 1 Active, closed OnKure, Inc. USA
A Real-life Study to Understand the Use and Effects of Palbociclib in US Patients With Breast Cancer
NCT06495164 · ClinicalTrials.gov ↗ · Breast Cancer, Malignant Neoplasm of Breast
Observational Active, closed Pfizer USA

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Ribociclib across our data

Ireland · EU · US

The same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.

Licensed in Ireland (HPRA)

1 single-substance product containing Ribociclib on the HPRA medicines list.

All 1 Irish product →

Supply shortages

No entry for Ribociclib in the EMA, FDA or German BfArM shortage lists we track.

03

Conditions studied with Ribociclib

41 conditions
Breast Cancer17Metastatic Breast Cancer7Early Breast Cancer2HR+/HER2- Breast Cancer2ER-Positive HER2-Negative Breast Cancer2Advanced Breast Cancer2Solid Tumor, Adult2HER2-negative Breast Cancer2Breast Neoplasms1Neoplasm Metastasis1Solid Tumors, Adult1Solid Tumors1
All 41 conditions
Condition (as registered)Trials
Breast Cancer17
Metastatic Breast Cancer7
Early Breast Cancer2
HR+/HER2- Breast Cancer2
ER-Positive HER2-Negative Breast Cancer2
Advanced Breast Cancer2
Solid Tumor, Adult2
HER2-negative Breast Cancer2
Breast Neoplasms1
Neoplasm Metastasis1
Solid Tumors, Adult1
Solid Tumors1
Locally Advanced (Inoperable) or Metastatic Breast Cancer1
ER+ HER2- Advanced Breast Cancer1
High-grade Serous Ovarian Cancer (HGSOC)1
Melanoma1
Locally Advanced Breast Cancer1
ER Positive Breast Cancer1
Advanced HR+/HER2- Breast Cancer1
Advanced CCNE1-amplified Solid Tumors1
Extensive-stage Small Cell Lung Cancer1
Advanced Solid Tumor1
HR+, HER2-, Advanced Breast Cancer1
CCNE1 Amplification1
Advanced Cancer1
Advanced Solid Tumors1
PI3K Gene Mutation1
PIK3CA Mutation1
HER2 Mutation-Related Tumors1
KRAS G12C Mutant Solid Tumors1
Carcinoma, Non-Small Cell Lung1
Carcinoma, Non-Small-Cell Lung1
Non-Small Cell Lung Cancer1
Malignant Neoplasm of Breast1
ER-positive Breast Cancer1
Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer1
Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer1
Breast Cancer Stage I1
Breast Cancer Stage II1
Locally Advanced Breast Cancer (LABC)1
Continued Access to Study Treatment(s), Cancers With a Mass, Bulky Tumor, Nodule, Lump, Advanced Cancer, Advanced Solid Tumors, Advanced Solid Malignancies1
04

Sponsors

lead sponsor per trial
Lead sponsorTrials
Novartis Pharmaceuticals9
Hoffmann-La Roche5
AstraZeneca5
Pfizer3
Eli Lilly and Company2
Olema Pharmaceuticals, Inc.2
Stemline Therapeutics, Inc.1
BeOne Medicines1
Incyte Corporation1
Avenzo Therapeutics, Inc.1
OnKure, Inc.1
Relay Therapeutics, Inc.1
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)1
Celcuity Inc1
Forward Pharmaceuticals Co., Ltd.1

+ 3 more sponsors in the trial list above.

05

By country register

RegisterTrialsRecruiting
Clinical trials in USA3417
Clinical trials in UK168
Clinical trials in China169
Clinical trials in India62
Clinical trials in Ireland42

A trial with sites in more than one country appears in each of those registers.

06

Related compounds

07

Questions about Ribociclib trials

How many clinical trials are testing Ribociclib?

38 current trials in our USA, UK, China, India and Ireland registers name Ribociclib (also registered as RO7072612) as a drug or biological intervention, as of the registry sync on 25 September 2026. Completed and withdrawn studies are not counted.

Are Ribociclib trials recruiting patients?

Yes. 20 of the 38 trials are recruiting: 17 with sites in USA, 8 with sites in UK, 9 with sites in China, 2 with sites in India and 2 with sites in Ireland. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Ribociclib clinical trials?

Novartis Pharmaceuticals (9), Hoffmann-La Roche (5), AstraZeneca (5) and Pfizer (3), among 18 lead sponsors in total. The number in brackets is how many trials each organisation leads.

Is Ribociclib licensed in Ireland?

Yes. The HPRA medicines list includes 1 single-substance product containing Ribociclib, for example Kisqali 200 mg film-coated tablets (Novartis Europharm Limited). A licence does not mean a product is currently marketed or reimbursed; see each product's record.

Is there a Ribociclib shortage?

Not in the lists we track: Ribociclib has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Ribociclib works or whether it is effective, and it is not medical advice.

How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records โ€” it is not written from memory, and nothing here describes how Ribociclib works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Ribociclib (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 25 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician โ€” our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us โ€” we correct promptly and log it.