Floatz Rating
B60/100
Confidence
Indicative
Sponsor
Xijing Hospital
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.
60High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07333937CT.gov Neratinib Combined With Fulvestrant and Eribulin in the Treatment ofHR+/HER2+ Advanced Breast Cancer | — | Not Yet Recruiting | — | — | — |
NCT05933395CT.gov Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor | — | Recruiting | — | — | — |
NCT06008275CT.gov Neratinib in Combination With Ruxolitinib in Patients With mTNBC | — | Recruiting | — | — | — |
NCT05919108CT.gov Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers | — | Recruiting | — | — | — |
NCT06015113CT.gov Efficacy and Safety of Disitamab Vedotin Plus Pyrotinib or Naratinib in HER2-positive Breast Cancer Patients With Brain Metastasis | — | Not Yet Recruiting | — | — | — |
NCT04901299CT.gov Fulvestrant + Neratinib In Breast Cancer | — | Withdrawn | — | — | — |
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 | — | — | — |
NCT05491057CT.gov Treatment Patterns of Neratinib in HER2+ EBC in China | — | Not Yet Recruiting | — | — | — |
NCT04965064CT.gov Trial of Neratinib Plus Capecitabine in Subjects With HER2-Negative Metastatic Breast Cancer With Brain Metastases and Abnormally Active HER2 Signaling | — | Recruiting | — | — | — |
Show 27 more trialsShow fewer
NCT05252988CT.gov Three Antidiarrheal Strategies in HER2+/HR+ Early Breast Cancer Patients Treated With Extended Adjuvant Neratinib | — | Active Not Recruiting | — | — | — |
NCT05243641CT.gov Neratinib and Capmatinib Combination (Phase Ib/II) in Metastatic Breast Cancer and Inflammatory Breast Cancer Patients With Abnormal HER-family and c-Met Pathway Activity as Measured by the CELsignia Signaling Analysis Test | — | Terminated | — | — | — |
NCT04886531CT.gov Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers | — | Recruiting | — | — | — |
NCT04856475CT.gov Evaluation of Neratinib for Treatment and Prevention of Subsequent CNS Event(s) in Patients With Brain Metastasis of Advanced HER2 Positive Breast Cancer | — | Withdrawn | — | — | — |
NCT04460430CT.gov Targeting EGFR/ERBB2 With Neratinib in Hormone Receptor (HR)-Positive/HER2-negative HER2-enriched Advanced/Metastatic Breast Cancer | — | Terminated | — | — | — |
NCT03878524CT.gov Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial | — | Terminated | — | — | — |
NCT03812393CT.gov Evaluating the Efficacy of Neratinib on Live Cell HER2 Signaling Transduction Analysis Positive Triple Negative Breast | — | Unknown | — | — | — |
NCT03094052CT.gov Incidence and Severity of Diarrhea in Patients With HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib | — | Completed | — | — | — |
NCT03101748CT.gov Neratinib and Paclitaxel With or Without Pertuzumab and Trastuzumab Before Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Breast Cancer | — | Terminated | — | — | — |
NCT03377387CT.gov Capecitabine 7/7 Schedule With Neratinib in Patients With Metastatic HER2-Positive Breast Cancer | — | Active Not Recruiting | — | — | — |
NCT03289039CT.gov Neratinib +/- Fulvestrant in HER2+, ER+ Metastatic Breast Cancer | — | Terminated | — | — | — |
NCT03182634CT.gov The UK Plasma Based Molecular Profiling of Advanced Breast Cancer to Inform Therapeutic CHoices (plasmaMATCH) Trial | — | Unknown | — | — | — |
NCT02673398CT.gov Neratinib in Treating Older Patients With Stage IV HER2-Positive Breast Cancer | — | Completed | — | — | — |
NCT02236000CT.gov A Dose-Escalation Study Evaluating the Combination of Trastuzumab Emtansine (T-DM1) With Neratinib in Women With Metastatic HER2-Positive Breast Cancer | — | Completed | — | — | — |
NCT01494662CT.gov HKI-272 for HER2-Positive Breast Cancer and Brain Metastases | — | Completed | — | — | — |
NCT01423123CT.gov Combination of Weekly Paclitaxel With Neratinib and Trastuzumab in Women With Metastatic HER2-positive Breast Cancer | — | Completed | — | — | — |
NCT01008150CT.gov Phase II Randomized Trial Evaluating Neoadjuvant Therapy With Neratinib and/or Trastuzumab Followed by Postoperative Trastuzumab in Women With Locally Advanced HER2-positive Breast Cancer | — | Completed | — | — | — |
NCT01111825CT.gov Temsirolimus Plus Neratinib for Patients With Metastatic HER2-Amplified or Triple Negative Breast Cancer | — | Completed | — | — | — |
NCT01042379CT.gov I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer | — | Recruiting | — | — | — |
NCT00915018CT.gov Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer | — | Completed | — | — | — |
NCT00878709CT.gov Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer | — | Completed | — | — | — |
NCT00777101CT.gov Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer | — | Completed | — | — | — |
NCT00741260CT.gov Study Evaluating The Combination Of Neratinib And Capecitabine In Solid Tumors And Breast Cancer | — | Completed | — | — | — |
NCT00708903CT.gov Study to Examine the Effect of HKI-272 on Rhythms of the Heart (Cardiac Repolarization) | — | Completed | — | — | — |
NCT00706030CT.gov Study Evaluating Neratinib (HKI-272) In Combination With Vinorelbine In Subjects With Solid Tumors And Metastatic Breast Cancer | — | Completed | — | — | — |
NCT00445458CT.gov A Phase 1/2 Study of HKI-272 (Neratinib) in Combination With Paclitaxel (Taxol) in Subjects With Solid Tumors and Breast Cancer | — | Completed | — | — | — |
NCT00398567CT.gov A Phase 1/2 Study Of HKI-272 (Neratinib) in Combination With Trastuzumab (Herceptin) In Subjects With Advanced Breast Cancer | — | Completed | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
59High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Breast Cancer
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Neratinib (this asset) | Xijing Hospital | P3 | B · 60 |
| Darolutamide | Vandana Abramson | P2 | BBB |
| Pertuzumab | SWOG Cancer Research Network | P4 | BB |
| Palbociclib | Hoffmann-La Roche | P4 | BB |
| Trastuzumab Duocarmazine | Byondis B.V. | P3 | BB |
| Goserelin | TerSera Therapeutics LLC | P4 | BB |
| Ribociclib | National Cancer Institute (NCI) | P4 | BB |
| Oxaliplatin | Beijing Biostar Pharmaceuticals Co., Ltd. | P4 | BB |
| Eribulin Monomethanesulfonate | Henan Cancer Hospital | P4 | BB |
+42 more in the Breast Cancer cohort
Other indications for Neratinib
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Breast Carcinoma | — | P2 | BB · 65 |
| Breast Neoplasm | — | P3 | B · 60 |
| Triple-Negative Breast Carcinoma | — | P2 | B · 58 |
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 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/neratinib-breast-cancer
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