Ribociclib
Her2-Receptor Negative Breast Cancer
Explore 186 assets in Her2-Receptor Negative Breast Cancer →Floatz Rating
BB65/100
Confidence
Indicative
Sponsor
National Cancer Institute (NCI)
Modality
Small molecule
Development Phase
Phase 4 / Approved
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
65High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07391774CT.gov 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 | — | Recruiting | — | — | — |
NCT07085767CT.gov Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer | — | Recruiting | — | — | — |
NCT06953882CT.gov Impact of Omitting Chemo Based on Patient's Selection for ER-Positive, HER2-Negative Breast Cancer With Ribociclib and Endocrine Therapy | — | Recruiting | — | — | — |
NCT06062498CT.gov Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer | — | Recruiting | — | — | — |
NCT05664893CT.gov Study to Determine the Safety and Efficacy of Ribociclib in Combination With Hormone Therapy and Hypofractionated Radiotherapy in Breast Cancer, With Positive Hormone Receptors and Negative HER2 Status, in Newly Diagnosed, Not Immediately Operable Elderly Patient (CALHYS) | — | Withdrawn | — | — | — |
NCT05826964CT.gov Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer | — | Active Not Recruiting | — | — | — |
NCT05759949CT.gov First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors | — | Completed | — | — | — |
NCT05163106CT.gov Neoadjuvant Treatment of Locally-advanced Breast Cancer Patients With Ribociclib and Letrozole | — | Completed | — | — | — |
NCT05452213CT.gov Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients | — | Recruiting | — | — | — |
NCT05467891CT.gov Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer | — | Recruiting | — | — | — |
Show 6 more trialsShow fewer
NCT05508906CT.gov Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer | — | Recruiting | — | — | — |
NCT05252416CT.gov (VELA) Study of BLU-222 in Advanced Solid Tumors | — | Terminated | — | — | — |
NCT05216432CT.gov First-in-Human Study of Mutant-selective PI3Kα 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 | — | Recruiting | — | — | — |
NCT03477396CT.gov Ribociclib and Aromatase Inhibitor in Treating Older Participants With Hormone Receptor Positive Metastatic Breast Cancer | — | Completed | — | — | — |
NCT03462251CT.gov Ribociclib and Endocrine Therapy or Chemotherapy With or Without Bevacizumab for Metastatic Breast Cancer in First Line | — | Completed | — | — | — |
NCT03294694CT.gov Ribociclib + PDR001 in Breast Cancer and Ovarian Cancer | — | Terminated | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
65High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Her2-Receptor Negative Breast Cancer
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Ribociclib (this asset) | National Cancer Institute (NCI) | Approved | BB · 65 |
| Palbociclib | Helwan University | P2 | BBB |
| Exemestane | National Cancer Institute (NCI) | P4 | BBB |
| Pembrolizumab | UNC Lineberger Comprehensive Cancer Center | P2 | BBB |
| Atezolizumab | TransThera Sciences (Nanjing), Inc. | P2 | BB |
| Palazestrant | Olema Pharmaceuticals, Inc. | P3 | BB |
| Docetaxel | Jiangsu Hansoh Pharmaceutical Co., Ltd. | P2/3 | BB |
| Durvalumab | National Cancer Institute (NCI) | P3 | BB |
| Capecitabine | Kristina A. Fanucci | P4 | BB |
+42 more in the Her2-Receptor Negative Breast Cancer cohort
Other indications for Ribociclib
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Hormone Receptor-Positive Breast Cancer | — | P4 | BBB · 73 |
| Breast Cancer | — | P4 | BB · 70 |
| Estrogen-Receptor Positive Breast Cancer | — | P3 | BB · 69 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Ribociclib in Her2-Receptor Negative Breast Cancer. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/ribociclib-her2-receptor-negative-breast-cancer
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