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Targeted & bispecific oncology · Live ClinicalTrials.gov data

Ribociclib (Kisqali) clinical trial pipeline

The timeline below tracks the 16 largest phase 2–4 ribociclib (Kisqali) trials on ClinicalTrials.gov by enrolment, 8 of them actively recruiting. The next phase 3 primary completion among them is expected Nov 2027. Refreshed daily. Add up to four competitors to compare pipelines side by side.

16+

Major trials tracked

7

Phase 3 trials

8

Actively recruiting

Nov 2027

Next phase 3 primary completion

12,532

Participants across trials

Fudan University

Lead sponsor by trial count

ribociclib (16)14 active2016–2032
ribociclib
Key
Actual date
Anticipated
Forecast to primary completion
RecruitingActive, not recruitingNot yet recruitingCompleted
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'28
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'32
ribociclib
MAINTAINP2
Endocrine Therapy Plus CDK4/6 in First or Second Line for Hormone (SONIA) Receptor Positive Advanced Breast CancerP3
Efficacy and Safety of Ribociclib in Pre- and Postmenopausal Chinese Women With HR Positive, HER2-negative, Advanced Breast Cancer.P2
CAPItello-292P3
RIBOLARISP2
FAIMP2
Comparison of Clinical Efficacy Between Letrozole + Ribociclib and Fulvestrant + Letrozole + Ribociclib in Hormone Receptor Positive, HER2 Negative Metastatic Breast CancerP2
ARIADNEP2
Adjuvant WIDERP3
Chemotherapy Omission in HR-positive/HER2-negative Breast Cancer With Lymph Node Negative Disease Receiving Adjuvant Endocrine Therapy and CDK4/6 InhibitorP3
SENIORP3
A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast CancerP2
OPERA-02P3
the Efficacy of Leucogen in Preventing the Risk of Ribociclib-Associated Neutropenia in Early Breast CancerP2
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 CancerP2
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 TrialP3

Upcoming readouts

13 ahead · ribociclib

Select a trial to load its full ClinicalTrials.gov record.

Key ribociclib trials

Top 12 of the 16 tracked phase 2–4 trials, ordered by phase and status. Trial names open the full ComplyRx trial page; NCT ids link to ClinicalTrials.gov.

TrialTitlePhaseStatusPrimary completion
NCT07085767OPERA-02: Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced B…Phase 3RecruitingDec 2028
NCT07391774Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Horm…Phase 3RecruitingJul 2029
NCT05827081Adjuvant WIDER: Phase IIIb Study of Ribociclib + ET in Early Breast CancerPhase 3RecruitingSept 2029
NCT03425838Endocrine Therapy Plus CDK4/6 in First or Second Line for Hormone (SONIA) Receptor Positive Adva…Phase 3Active, not recruitingMar 2023
NCT04862663CAPItello-292: Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-…Phase 3Active, not recruitingNov 2027
NCT07005557SENIOR: Chemo-free in Older (≥65) Node-Positive ER+/HER2- Breast CancerPhase 3Not yet recruitingMay 2030
NCT06996093Chemotherapy Omission in HR-positive/HER2-negative Breast Cancer With Lymph Node Negative Diseas…Phase 3Not yet recruitingJun 2030
NCT05900206ARIADNE: Trastuzumab Deruxtecan Versus Standard Neoadjuvant Treatment for HER2-positive Breast CancerPhase 2RecruitingApr 2027
NCT07054190A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Ca…Phase 2RecruitingJul 2027
NCT07380646the Efficacy of Leucogen in Preventing the Risk of Ribociclib-Associated Neutropenia in Early Br…Phase 2RecruitingJan 2028
NCT07405801A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestra…Phase 2RecruitingDec 2028
NCT05816655Comparison of Clinical Efficacy Between Letrozole + Ribociclib and Fulvestrant + Letrozole + Rib…Phase 2RecruitingDec 2028

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Get an alert when a trial changes status, moves its completion date, or a new trial registers in scope. Checked nightly against ClinicalTrials.gov.

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FAQ

How many clinical trials are running for ribociclib?
ClinicalTrials.gov lists more than 16 phase 2–4 ribociclib trials. This page tracks the 16 largest by enrolment: 9 phase 2, 7 phase 3, and 0 phase 4 among them, with 8 actively recruiting. Updated daily.
Are there clinical trials for Kisqali?
Kisqali is the brand name for ribociclib, so ribociclib trials on ClinicalTrials.gov cover it. ClinicalTrials.gov lists more than 16 phase 2–4 ribociclib trials. This page tracks the 16 largest by enrolment: 9 phase 2, 7 phase 3, and 0 phase 4 among them, with 8 actively recruiting. Updated daily.
Where does this data come from?
All trial data is sourced from ClinicalTrials.gov (CTGov) and refreshed on this page daily.
Can I compare ribociclib against other drugs?
Yes. The free ComplyRx Trial Pipeline tool compares up to five drugs side by side on one timeline, with PNG and PDF export. Add any competitor in the search box above.
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