Floatz Rating
CCC48/100
Confidence
Indicative
Sponsor
Second Affiliated Hospital of Soochow University
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.
38Indicative
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT06235931CT.gov A Clinical Study of Darcilil Combined With AI Combined With Pyrrotinib in the Treatment of TPBC | — | Recruiting | — | — | — |
NCT05582499CT.gov Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy | — | Recruiting | — | — | — |
NCT05577442CT.gov Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy for HR +/HER2 + Advanced Breast Cancer | — | Unknown | — | — | — |
NCT05328440CT.gov Treatment of Dalpiciclib Combined With Pyrotinib for Trastuzumab-sensitive HER2+ Advanced Breast Cancer(DAP-Her-02) | — | Unknown | — | — | — |
NCT06234137CT.gov A Prospective, Open, Multicenter Single-arm Clinical Studie of Docetaxel, Carboplatin Combined With Inetetamab and Pyrotinib in the Treatment of Local-advanced HER2-positive Breast Cancer | — | Recruiting | — | — | — |
NCT04983121CT.gov Efficacy and Safety of Pyrotinib Maleate Combined With ARX788 Neoadjuvant Treatment in Breast Cancer Patients | — | Recruiting | — | — | — |
NCT05764941CT.gov Inetetamab Combined With Pyrotinib and Vinorelbine as First-line to Third-line Treatment for HER2-positive Metastatic Breast Cancer | — | Unknown | — | — | — |
NCT03756064CT.gov Neoadjuvant Study of Pyrotinib in Patients With HER2 Positive Breast Cancer | — | Unknown | — | — | — |
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 · Breast Neoplasm
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Pyrotinib (this asset) | Second Affiliated Hospital of Soochow University | P2 | CCC · 48 |
| Letrozole | Fujian Cancer Hospital | P4 | BB |
| Adriamycin | Merck Sharp & Dohme LLC | P4 | BB |
| Exemestane | Fujian Cancer Hospital | P4 | BB |
| Tamoxifen | Eli Lilly and Company | P3 | BB |
| Docetaxel | Universitas Airlangga | P4 | BB |
| Cyclophosphamide | Merck Sharp & Dohme LLC | P4 | BB |
| Microporous Polysaccharide Hemospheres | Fundación para la Investigación del Hospital Clínico de Valencia | P4 | BB |
| Epirubicin | Universitas Airlangga | P4 | BB |
+42 more in the Breast Neoplasm cohort
Other indications for Pyrotinib
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Breast Carcinoma | — | P3 | BB · 70 |
| HER2 Positive Breast Carcinoma | — | P4 | BB · 66 |
| Invasive Breast Carcinoma | — | P3 | BB · 64 |
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. Pyrotinib in Breast Neoplasm. 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/pyrotinib-breast-neoplasm-113912
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