Floatz Rating
BB66/100
Confidence
Indicative
Sponsor
Peking University People's Hospital
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.
67High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07610720CT.gov Dalpiciclib, Anti-HER2 Therapy, and Endocrine Therapy for Hormone-Receptor-Positive, HER2-Positive Metastatic Breast Cancer | — | Recruiting | — | — | — |
NCT07600164CT.gov Real-world Study of Pyrotinib-containing Regimens of Advanced HER2-positive Breast Cancer | — | Not Yet Recruiting | — | — | — |
NCT07417241CT.gov SHR-A1811 vs Pyrotinib/Capecitabine in Trastuzumab-Resistant HER2+ Advanced Breast Cancer: A Randomized Study | — | Not Yet Recruiting | — | — | — |
NCT07470203CT.gov Pyrotinib Combined With Trastuzumab and Pertuzumab for Maintenance Therapy in HER2-Positive Advanced Breast Cancer | — | Not Yet Recruiting | — | — | — |
NCT07393425CT.gov Neoadjuvant Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab in HER2+ Breast Cancer | — | Recruiting | — | — | — |
NCT07340398CT.gov Neoadjuvant Trastuzumab-rezetecan Plus Pertuzumab or Nab-Paclitaxel, Carboplatin, Trastuzumab, and Pyrotinib After Suboptimal Response to Neoadjuvant Dual HER2-Targeted Therapy Combined With Chemotherapy in HER2-Positive Early Breast Cancer | — | Recruiting | — | — | — |
NCT07307287CT.gov SHR-A1811 Plus Pertuzumab as Neoadjuvant Therapy for Early or Locally Advanced HR-Positive HER2-Positive Breast Cancer: A Prospective, Open-Label, Phase II Study | — | Not Yet Recruiting | — | — | — |
NCT07239271CT.gov A Multicenter Phase III Clinical Study and Translational Research on Adaptive Neoadjuvant Therapy of De-escalation and Escalation for HER2-Positive Breast Cancer Based on Multi-Omics Response Evaluation Model | — | Not Yet Recruiting | — | — | — |
NCT07179939CT.gov Maintenance Therapy in HER2-Positive Unresectable Locally Recurrent or Metastatic Breast Cancer: A Phase II Study | — | Not Yet Recruiting | — | — | — |
NCT06973525CT.gov This Study Aims to Optimize Neoadjuvant Therapy for HER2-positive Breast Cancer by Implementing a Dynamic Monitoring-guided Treatment Strategy. | — | Not Yet Recruiting | — | — | — |
Show 49 more trialsShow fewer
NCT07132242CT.gov SHR-A1811 Combine With Pyrotinib for Locally Advanced/Metastatic HER2 Positive Breast Cancer | — | Not Yet Recruiting | — | — | — |
NCT07019337CT.gov Oral Metronomic Capecitabine Combined With Pyrotinib in ADC-treated HER2-positive Metastatic Breast Cancer | — | Not Yet Recruiting | — | — | — |
NCT06718335CT.gov Pyrotinib in HER2-positive Early Breast Cancer | — | Not Yet Recruiting | — | — | — |
NCT06832904CT.gov Neoadjuvant Chemotherapy Plus Pyrotinib and Trastuzumab for HER2-positive Breast Cancer (NEOTORCH-BREAST05) | — | Recruiting | — | — | — |
NCT07635342CT.gov Pyrotinib Plus Trastuzumab and Chemotherapy for HER2-Positive Early Breast Cancer | — | Recruiting | — | — | — |
NCT06958627CT.gov The Impact of Intelligent Patient Management Model on Medication Adherence of Pyrotinib Compared to Traditional Patient Management Model: a Prospective, Multicenter, Randomized Controlled Clinical Study | — | Recruiting | — | — | — |
NCT06217185CT.gov The Efficacy and Safety of Pyrotinib, Trastuzumab Combined With Taxanes in the Treatment of Trastuzumab-treated HER2+ Advanced Breast Cancer (ABC). | — | Recruiting | — | — | — |
NCT07065435CT.gov RC48 Plus Bevacizumab or Pyrotinib in HER2-Positive Metastatic Breast Cancer After T-DXd Failure: A Phase II Study | — | Recruiting | — | — | — |
NCT06278870CT.gov Disitamab Vedotin + Pyrotinib Versus THP in the First-line Treatment for HER2+ Advanced Breast Cancer Clinical Trial | — | Recruiting | — | — | — |
NCT06035016CT.gov Pyrotinib Plus Capecitabine for Adjuvant Treatment of HER2 Positive Early-stage Breast Cancer | — | Recruiting | — | — | — |
NCT05918328CT.gov Comparing the Efficacy of Nab-PH+Pyrrolitinib and TCbHP in the Neoadjuvant Treatment of HER2 Positive BC | — | Recruiting | — | — | — |
NCT05834764CT.gov Pyrotinib in Women With High-risk in Early Stage Breast Cancer | — | Recruiting | — | — | — |
NCT05635487CT.gov A Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients | — | Recruiting | — | — | — |
NCT05621434CT.gov A Study to Evaluate Inetetamab + Pyrotinib + Chemotherapy in Previously Untreated HER2-Positive Metastatic Breast Cancer | — | Unknown | — | — | — |
NCT06470347CT.gov A Real-World Study of Pyrrolitinib Maleate Tablets for HER-2-Positive Early or Locally Advanced Breast Cancer After Adjuvant Trastuzumab Therapy | — | Recruiting | — | — | — |
NCT05582499CT.gov Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy | — | Recruiting | — | — | — |
NCT05561686CT.gov Real-world Study of Pyrotinib in Neoadjuvant Therapy for HER2-positive Breast Cancer | — | Unknown | — | — | — |
NCT05575804CT.gov GQ1001 Combined With Pyrotinib for Treatment With HER2 Positive Metastatic Breast Cancer | — | Unknown | — | — | — |
NCT05560308CT.gov Phase II Clinical Study of T-DM1 and Pyrotinib Maleate in Patients With HER2-positive Metastatic Breast Cancer Who Had Progressed on TKI Therapy | — | Unknown | — | — | — |
NCT04997798CT.gov Dalpiciclib in Combination With Exemestane and Trastuzumab Plus Pyrotinib in Early Triple Positive Breast Cancer | — | Unknown | — | — | — |
NCT05424835CT.gov A Trial of SHR-A1811versus Pyrotinib in Combination With Capecitabine in HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane | — | Active Not Recruiting | — | — | — |
NCT05429294CT.gov Novel Double Target Therapy Combined With Chemotherapy in First-line Treatment of HER2+ Breast Cancer, MA-BC-II-038 | — | Unknown | — | — | — |
NCT05426486CT.gov A Study of ARX788 Combined With Pyrotinib Maleate Versus TCBHP (Trastuzumab Plus Pertuzumab With Docetaxel and Carboplatin) as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients | — | Active Not Recruiting | — | — | — |
NCT05856383CT.gov Efficacy and Safety of Inetetamab Combined With Pyrotinib and Vinorelbine in ABC | — | Recruiting | — | — | — |
NCT05252546CT.gov Effect of Montmorillonite Power or Loperamide on the Pharmacokinetics of Pyrotinib in Healthy Subjects | — | Completed | — | — | — |
NCT05042791CT.gov A Study of Pyrotinib Plus Capecitabine Combined With SRT in HER2+ MBC With Brain Metastases | — | Unknown | — | — | — |
NCT05076695CT.gov Neoadjuvant With Trastuzumab, Pyrotinib Plus Palbociclib and Fulvestrant in HER2-positive, ER-positive Breast Cancer | — | Unknown | — | — | — |
NCT05346861CT.gov Pyrotinib Rechallenge in Her2-positive Metastatic Breast Cancer Pretreated With Pyrotinib and Trastuzumab | — | Unknown | — | — | — |
NCT06754059CT.gov Pyrotinib Combined With Trastuzumab for Maintenance Therapy After First-line TH (P) Therapy for HER2+ABC | — | Recruiting | — | — | — |
NCT04900311CT.gov Pyrotinib Versus Pertuzumab in Combination With Neoadjuvant Trastuzumab and Nab-Paclitaxel in HER2+ Early or Locally Advanced Breast Cancer | — | Unknown | — | — | — |
NCT04802876CT.gov Efficacy of Tislelizumab and Spartalizumab Across Multiple Cancer-types in Patients with PD1-high MRNA Expressing Tumors | — | Active Not Recruiting | — | — | — |
NCT04903652CT.gov Pyrotinib Maleate Combined With Vinorelbine in the Treatment of HER2-positive Advanced Breast Cancer | — | Completed | — | — | — |
NCT04639271CT.gov Pyrotinib, Trastuzumab And Abraxane in HER2-positive MBC With Brain Metastasis | — | Unknown | — | — | — |
NCT05429684CT.gov Precise Therapy for Refractory HER2 Positive Advanced Breast Cancer | — | Unknown | — | — | — |
NCT04481932CT.gov Trastuzumab Combined With Pyrrolidine and Chemotherapy for Locally HER2 Positive Breast Cancer | — | Recruiting | — | — | — |
NCT04158856CT.gov Adjuvant Dual Anti-HER2 Therapy in Patients With Small, Node-negative, HER2-positive Breast Cancer | — | Not Yet Recruiting | — | — | — |
NCT04605575CT.gov Pyrotinib Plus Vinorelbine in Participants With HER2-positive Previously Treated Locally Advanced or Metastatic Breast Cancer | — | Unknown | — | — | — |
NCT04236310CT.gov A Study of Neoadjuvant SHR6390 in Combination With Anastrozole, Pyrotinib, and Trastuzumab in Patients With ER+/HER2+ Breast Cancer. | — | Unknown | — | — | — |
NCT04088110CT.gov Pyrotinib Combined With Trastuzumab Plus Aromatase Inhibitor in Treatment of Breast Cancer | — | Unknown | — | — | — |
NCT04152057CT.gov Pyrotinib Maleate Tablets Combined With Albumin Paclitaxel and Trastuzumab for Her2-positive Breast Cancer | — | Unknown | — | — | — |
NCT04095390CT.gov A Phase Ⅱ Trial of Pyrotinib Combination With CDK4/6 Inhibitor SHR6390 in Patients Prior Trastuzumab-treated Advanced HER2-Positive Breast Cancer | — | Unknown | — | — | — |
NCT03910712CT.gov Pyrotinib Combined With Trastuzumab and AI in the First-line Treatment of HER2 Positive/ HR Positive MBC | — | Unknown | — | — | — |
NCT03947242CT.gov Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Vinorelbine in Trastuzumab-refractory HER2-Positive Breast Cancer. | — | Unknown | — | — | — |
NCT03919253CT.gov Pyrotinib in Combination With Nab-paclitaxel in Patients With HER2-positive Advanced Breast Cancer: an Exploratory Study | — | Unknown | — | — | — |
NCT03847818CT.gov Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Chemotherapy in Patients With HER2 Positive Breast Cancer | — | Unknown | — | — | — |
NCT03735966CT.gov Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Docetaxel and Carboplatin in HER2 Positive Breast Cancer Patients. | — | Completed | — | — | — |
NCT04033172CT.gov Pyrotinib Plus Fulvestrant in Patients With HR+/HER2+ Metastatic Breast Cancer (Pyrotinib+Fulvestrant ) | — | Unknown | — | — | — |
NCT04756921CT.gov 18F-FDG Uptake Heterogeneity Predicts Pyrotinib Response | — | Completed | — | — | — |
NCT03588091CT.gov Neoadjuvant Study of Pyrotinib in Combination With Trastuzumab in Patients With HER2 Positive Breast Cancer | — | Completed | — | — | — |
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 |
|---|---|---|---|
| Pyrotinib (this asset) | Peking University People's Hospital | Approved | BB · 66 |
| Trastuzumab | SWOG Cancer Research Network | P4 | BB |
| Pertuzumab | SWOG Cancer Research Network | P4 | BB |
| Ribociclib | Danish Breast Cancer Cooperative Group | P3 | BB |
| Cyclophosphamide | National University Hospital, Singapore | P3 | BB |
| Vinorelbine Ditartrate | Fudan University | P3 | BB |
| Docetaxel | Ohio State University Comprehensive Cancer Center | P3 | BB |
| Capecitabine | MedSIR | P4 | BB |
| gb221 | Genor Biopharma Co., Ltd. | P3 | BB |
+42 more in the HER2 Positive Breast Carcinoma cohort
Other indications for Pyrotinib
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Breast Carcinoma | — | P3 | BB · 70 |
| Invasive Breast Carcinoma | — | P3 | BB · 64 |
| Hormone Receptor-Positive Breast Cancer | — | 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 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/pyrotinib-her2-positive-breast-carcinoma
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