Alpelisib
Her2-Receptor Negative Breast Cancer
Explore 186 assets in Her2-Receptor Negative Breast Cancer →Floatz Rating
CCC54/100
Confidence
Indicative
Sponsor
National Cancer Institute (NCI)
Modality
Small molecule
Development Phase
Phase 2
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
47High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT05967286CT.gov Olaparib and Alpelisib for Treatment of Metastatic Breast Cancer, A ComboMATCH Treatment Trial | — | Withdrawn | — | — | — |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 | — | — | — |
NCT05564377CT.gov Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial | — | Recruiting | — | — | — |
NCT05101564CT.gov Umbrella Trial of Subtype-Targeted Therapies in ER+/HER2- Breast Cancer | — | Completed | — | — | — |
NCT05660083CT.gov Alpelisib/iNOS Inhibitor/Nab-paclitaxel in Patients With HER2 Negative Metaplastic Breast Cancer (MpBC) | — | Recruiting | — | — | — |
NCT05508906CT.gov Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer | — | Recruiting | — | — | — |
NCT04965688CT.gov Biology Guided Therapy for Breast Cancer for ER Positive | — | Terminated | — | — | — |
NCT04762979CT.gov Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer | — | Active Not Recruiting | — | — | — |
NCT03207529CT.gov Alpelisib and Enzalutamide in Treating Patients With Androgen Receptor and PTEN Positive Metastatic Breast Cancer | — | Completed | — | — | — |
NCT01791478CT.gov BYL719 and Letrozole in Post-Menopausal Patients With Hormone Receptor-Positive Metastatic Breast Cancer | — | Active Not Recruiting | — | — | — |
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 |
|---|---|---|---|
| Alpelisib (this asset) | National Cancer Institute (NCI) | P2 | CCC · 54 |
| 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 |
| Capecitabine | Kristina A. Fanucci | P4 | BB |
| Docetaxel | Jiangsu Hansoh Pharmaceutical Co., Ltd. | P2/3 | BB |
| Durvalumab | National Cancer Institute (NCI) | P3 | BB |
+42 more in the Her2-Receptor Negative Breast Cancer cohort
Other indications for Alpelisib
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Triple-Negative Breast Carcinoma | — | P3 | BB · 67 |
| Breast Cancer | — | P4 | BB · 66 |
| HER2 Positive Breast Carcinoma | — | P3 | BB · 66 |
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. Alpelisib 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/alpelisib-her2-receptor-negative-breast-cancer
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