Floatz Rating
B57/100
Confidence
Indicative
Sponsor
Fudan University
Modality
Small molecule
Development Phase
Phase 3
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
53High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07152782CT.gov T-DXd With or Without Neratinib for HER2 Positive Breast Cancer With Brain Metastasis | — | Not Yet Recruiting | — | — | — |
NCT07019272CT.gov Neratinib in Extended Adjuvant Treatment for HER2+ Early Breast Cancer With pCR But High-Risk Features: A Hebei Multi-Center Real-World Study | — | Not Yet Recruiting | — | — | — |
NCT05760612CT.gov Adjuvant Trastuzumab Plus Neratinib in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer After Neoadjuvant Trastuzumab Plus Pertuzumab | — | Recruiting | — | — | — |
NCT05388149CT.gov Kadcyla And Neratinib for Interception of HER2+ Breast Cancer With Molecular Residual Disease | — | Recruiting | — | — | — |
NCT05252988CT.gov Three Antidiarrheal Strategies in HER2+/HR+ Early Breast Cancer Patients Treated With Extended Adjuvant Neratinib | — | Active Not Recruiting | — | — | — |
NCT04886531CT.gov Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers | — | Recruiting | — | — | — |
NCT05154396CT.gov Neratinib Dose Escalation Regimen for HER2 Positive Early Breast Cancer | — | Unknown | — | — | — |
NCT04366713CT.gov A Study to Characterize Colon Pathology in Patients With HER2 Amplified Breast Cancer Treated With Neratinib | — | Completed | — | — | — |
NCT03812393CT.gov Evaluating the Efficacy of Neratinib on Live Cell HER2 Signaling Transduction Analysis Positive Triple Negative Breast | — | Unknown | — | — | — |
NCT06693024CT.gov Adjuvant Therapy With Neratinib in HER2 Positive Early Breast Cancer | — | Recruiting | — | — | — |
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NCT03094052CT.gov Incidence and Severity of Diarrhea in Patients With HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib | — | Completed | — | — | — |
NCT02673398CT.gov Neratinib in Treating Older Patients With Stage IV HER2-Positive Breast Cancer | — | Completed | — | — | — |
NCT02400476CT.gov An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide | — | Completed | — | — | — |
NCT01808573CT.gov A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting | — | Completed | — | — | — |
NCT01042379CT.gov I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer | — | 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 Positive Breast Carcinoma
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Neratinib (this asset) | Fudan University | P3 | B · 57 |
| Trastuzumab | SWOG Cancer Research Network | P4 | BB |
| Pertuzumab | SWOG Cancer Research Network | P4 | BB |
| Ribociclib | Danish Breast Cancer Cooperative Group | P3 | BB |
| Docetaxel | Ohio State University Comprehensive Cancer Center | P3 | BB |
| Cyclophosphamide | National University Hospital, Singapore | P3 | BB |
| Capecitabine | MedSIR | P4 | BB |
| Vinorelbine Ditartrate | Fudan University | P3 | BB |
| gb221 | Genor Biopharma Co., Ltd. | P3 | BB |
+42 more in the HER2 Positive Breast Carcinoma cohort
Other indications for Neratinib
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Breast Carcinoma | — | P2 | BB · 65 |
| Breast Cancer | — | P3 | B · 60 |
| Breast Neoplasm | — | P3 | B · 60 |
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. Neratinib in HER2 Positive Breast Carcinoma. 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/neratinib-her2-positive-breast-carcinoma
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