16+
Major trials tracked
Targeted & bispecific oncology · Live ClinicalTrials.gov data
Ribociclib (Kisqali) clinical trial pipeline
The timeline below tracks the 16 largest phase 2–4 ribociclib trials on ClinicalTrials.gov by enrolment, 9 of them actively recruiting. The next phase 3 primary completion among them is expected Jul 2027. Refreshed daily — add up to four competitors to compare pipelines side by side.
8
Phase 3 trials
9
Actively recruiting
Jul 2027
Next phase 3 primary completion
12,970
Participants across trials
West German Study Group
Lead sponsor by trial count
ribociclib (16)13 active2014–2035
ribociclib
'14
'16
'18
'20
'22
'24
'26
'28
'30
'32
'34
ribociclib
DETECT IV - A Study in Patients With HER2-negative Metastatic Breast Cancer and Persisting HER2-negative Circulating Tumor Cells (CTCs).P2
LOGIC-2P2
COMPLEEMENT-1P3
ADAPTcycleP3
MegaMOSTP2
SAFIR 03P2
Efficacy and Safety of Ribociclib in Combination With NSAI Versus Physician's Choice of Chemotherapy Sequential Endocrine Therapy in HR+/HER2- Advanced Breast CancerP2
EvoPAR-BR01P3
Efficacy and Safety of Ribociclib Combined With AI Versus Physician&Amp;#39;s Choice of Chemotherapy Sequential Endocrine Therapy in ER Middle-low-expression/HER2-negative Advanced Breast Cancer (Rachel)P2
Chemotherapy Omission in HR-positive/HER2-negative Breast Cancer With Lymph Node Negative Disease Receiving Adjuvant Endocrine Therapy and CDK4/6 InhibitorP3
ITHRANP2
OPERA-02P3
A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)P3
the Efficacy of Leucogen in Preventing the Risk of Ribociclib-Associated Neutropenia in Early Breast CancerP2
ADAPTelaP3
SERAFA-1P3
Upcoming readouts
11 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. Each links to its full ClinicalTrials.gov record.
| Trial | Title | Phase | Status | Primary completion |
|---|---|---|---|---|
| NCT07085767 | OPERA-02 — Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer | Phase 3 | Recruiting | Dec 2028 |
| NCT07647328 | SERAFA-1 — A Phase IIIb Study to Evaluate Camizestrant Plus Ribociclib in ER-positive, HER2-negative Advanced Breast Canc… | Phase 3 | Recruiting | Feb 2029 |
| NCT06380751 | EvoPAR-BR01 — Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestra… | Phase 3 | Recruiting | Mar 2029 |
| NCT07174336 | A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Brea… | Phase 3 | Recruiting | May 2029 |
| NCT07242352 | ADAPTela — Marker - Adjusted Therapy Comparing Adjuvant Elacestrant With Standard Endocrine Treatment in Genomically and/… | Phase 3 | Recruiting | Sept 2033 |
| NCT04055493 | ADAPTcycle — Adj. Marker-adjusted Personalized Therapy Comparing ET+Ribociclib vs Chemotherapy in Intermediate Risk, HR+/HE… | Phase 3 | Active, not recruiting | Jul 2027 |
| NCT06996093 | Chemotherapy Omission in HR-positive/HER2-negative Breast Cancer With Lymph Node Negative Disease Receiving Ad… | Phase 3 | Not yet recruiting | Jun 2030 |
| NCT02941926 | COMPLEEMENT-1 — Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment… | Phase 3 | Completed | Nov 2019 |
| NCT06656624 | Efficacy and Safety of Ribociclib Combined With AI Versus Physician&Amp;#39;s Choice of Chemotherapy Sequentia… | Phase 2 | Recruiting | Dec 2025 |
| NCT04116541 | MegaMOST — A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristic… | Phase 2 | Recruiting | Oct 2026 |
| NCT07180160 | ITHRAN — Iparomlimab and Tuvonralimab (QL1706) in Patients With HR-positive, HER2-negative Advanced Breast Cancer | Phase 2 | Recruiting | Sept 2027 |
| NCT07380646 | the Efficacy of Leucogen in Preventing the Risk of Ribociclib-Associated Neutropenia in Early Breast Cancer | Phase 2 | Recruiting | Jan 2028 |
Related drug pipelines
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: 8 phase 2, 8 phase 3, and 0 phase 4 among them, with 9 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.
Join the waitlist
Be the first to access ComplyRx
We'll let you know as soon as your spot opens to use ComplyRx.
By joining, you agree to our Privacy Policy.