Floatz Rating
B63/100
Confidence
Indicative
Sponsor
Fudan University
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.
65High 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 | — | — | — |
NCT07528716CT.gov Artificial Intelligence Model-Guided Neoadjuvant Anti-HER2 Targeted Therapy | — | Not Yet Recruiting | — | — | — |
NCT06495541CT.gov The Real World Study of Pyrotinib in the Treatment of Advanced Breast Cancer With HER2 Positive | — | Not Yet Recruiting | — | — | — |
NCT07417241CT.gov SHR-A1811 vs Pyrotinib/Capecitabine in Trastuzumab-Resistant HER2+ Advanced Breast Cancer: A Randomized Study | — | Not Yet 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 | — | — | — |
NCT07189884CT.gov Pyrotinib Maleate Tablets in Combination With Dalpiciclib Isethionate Tablets and Standard Endocrine Therapy | — | Not Yet Recruiting | — | — | — |
NCT07180082CT.gov Continuous or Intermittent Pyrotinib for HER2-positive Advanced Breast Cancer | — | Recruiting | — | — | — |
NCT07047443CT.gov SHR-1811 Combined With Carboplatin in the Treatment of Advanced Breast Cancer With HER2 Expression | — | Not Yet Recruiting | — | — | — |
NCT07019337CT.gov Oral Metronomic Capecitabine Combined With Pyrotinib in ADC-treated HER2-positive Metastatic Breast Cancer | — | Not Yet Recruiting | — | — | — |
Show 93 more trialsShow fewer
NCT06975475CT.gov SHR-A1811 and THPy in First or Second Line for HER2 Positive Advanced Breast Cancer Brain Metastases | — | Not Yet Recruiting | — | — | — |
NCT07615751CT.gov Pyrotinib and Trastuzumab Combined With Dalpiciclib Versus Combined With Docetaxel in Advanced HER2-Positive Breast Cancer | — | Recruiting | — | — | — |
NCT06718933CT.gov Study of SHR-A1811 Combined With Pyrotinib and Bevacizumab in Advanced Breast Cancer With Brain Metastasis | — | Recruiting | — | — | — |
NCT06770296CT.gov The Dosing Regimen of Pyrotinib in HER2-positive Advanced First-line Breast Cancer: a Phase I Clinical Study | — | Recruiting | — | — | — |
NCT06483386CT.gov Pyrotinib and Subcutaneous Preparation of Trastuzumab Combined With Capecitabine Neoadjuvant Therapy for HER2+ Study of Breast Cancer | — | Not Yet Recruiting | — | — | — |
NCT06362096CT.gov A Multicenter, Prospective Study of Diarrhea Tolerance of Pyrotinib Combined With Trastumab and Taxane in the First-line Treatment of HER2-positive Advanced Breast Cancer | — | Unknown | — | — | — |
NCT07335081CT.gov ctDNA in HER2+ EBC Neoadjuvant Treatment | — | Recruiting | — | — | — |
NCT06245824CT.gov Trastuzumab Deruxtecan (T-DXd) With Pyrotinib in First-line HER2-positive Unresectable or Metastatic Breast Cancer Trial | — | Not Yet Recruiting | — | — | — |
NCT06144944CT.gov Neoadjuvant Pyrotinib in HR-positive and HER2-low High-risk Early Breast Cancer | — | Active Not 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 | — | — | — |
NCT06254690CT.gov The Dosing Regimen of Pyrotinib in HER2-positive Advanced First-line Breast Cancer: a Phase II Clinical Study | — | Recruiting | — | — | — |
NCT06152822CT.gov Pyrotinib Combined With Capecitabine and Bevacizumab for Patients With HER2 Positive Breast Cancer and Brain Metastases | — | Unknown | — | — | — |
NCT06001086CT.gov A Phase II Clinical Study of Treatment With Disitamb Vedotin Plus Pyrotinib in HER2-positive Early Breast Cancer | — | 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 | — | — | — |
NCT06035679CT.gov Pyrotinib Combined With Trastuzumab and Chemotherapy Neoadjuvant Therapy for HER2-positive Breast Cancer | — | Recruiting | — | — | — |
NCT05861271CT.gov Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer | — | Recruiting | — | — | — |
NCT06035016CT.gov Pyrotinib Plus Capecitabine for Adjuvant Treatment of HER2 Positive Early-stage Breast Cancer | — | Recruiting | — | — | — |
NCT06000917CT.gov A Study of Neoadjuvant TCHpy（Pyrotinib ，Trastuzumab，Carboplatin and Paclitaxel）for ER+/HER2+ Breast Cancer | — | Recruiting | — | — | — |
NCT05841381CT.gov Adjuvant Study of Pyrotinib in Combination With Trastuzumab in HER2 Positive Invasive Breast Cancer | — | Not Yet Recruiting | — | — | — |
NCT05918328CT.gov Comparing the Efficacy of Nab-PH+Pyrrolitinib and TCbHP in the Neoadjuvant Treatment of HER2 Positive BC | — | Recruiting | — | — | — |
NCT05806671CT.gov Dalpiciclib Plus Fulvestrant With Pyrotinib in Hormone Receptor-positive, HER2-low Advanced Breast Cancer That Progressed on Previous CDK4/6i Plus AI Therapy | — | Unknown | — | — | — |
NCT05430347CT.gov Clinical Study of Pyrotinib in Neoadjuvant Therapy of HR-positive and HER2-positive Breast Cancer | — | Unknown | — | — | — |
NCT05769010CT.gov Study of SHR-A1811 in HER2-expression Advanced Breast Cancer With Brain Metastases | — | Recruiting | — | — | — |
NCT07014410CT.gov Pyrotinib Combined With Dalpiciclib Combined With Letrozole in ER-positive and HER2-positive Advanced Breast Cancer | — | Recruiting | — | — | — |
NCT05638594CT.gov Pyrotinib Combined With Trastuzumab, Dalpiciclib, Letrozole Versus TCbHP (Trastuzumab Plus Pertuzumab With Docetaxel and Carboplatin) as Neoadjuvant Treatment in HR +/HER2 + Breast Cancer | — | Recruiting | — | — | — |
NCT05659056CT.gov Neoadjuvant Study With Pyrotinib and Trastuzumab and Abraxane in Patients With HER2-enriched Breast Cancer | — | Unknown | — | — | — |
NCT05582499CT.gov Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy | — | Recruiting | — | — | — |
NCT05577923CT.gov Exploring Whether Disease-free Intervals Can Guide Endocrine Combined Targeted Therapy for ER+/HER2+ Advanced Breast Cancer (T-sunflower) | — | Unknown | — | — | — |
NCT05572645CT.gov Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab | — | Completed | — | — | — |
NCT04997798CT.gov Dalpiciclib in Combination With Exemestane and Trastuzumab Plus Pyrotinib in Early Triple Positive Breast Cancer | — | Unknown | — | — | — |
NCT05800756CT.gov Pyrotinib Combined With Trastuzumab,Dalpiciclib and Letrozole for HR+/HER2+ Breast Cancer | — | Unknown | — | — | — |
NCT05255523CT.gov Pyrotinib Plus Trastuzumab After First-line TH (P) Treatment With HER-2 Positive Breast Cancer | — | Unknown | — | — | — |
NCT05823623CT.gov Inetetamab Combined With Pyrotinib Plus Oral Vinorelbine for the Treatment of HER2-positive Metastatic Breast Cancer | — | Unknown | — | — | — |
NCT05228951CT.gov Pyrotinib Maleate, Trastuzumab, SHR6390 and Letrozole in Combination for Stage II-III TPBC | — | Recruiting | — | — | — |
NCT04929548CT.gov Exploratory Study of Neoadjuvant Treatment of HER2-positive Breast Cancer With Py in Combination With HP | — | Not Yet Recruiting | — | — | — |
NCT05346861CT.gov Pyrotinib Rechallenge in Her2-positive Metastatic Breast Cancer Pretreated With Pyrotinib and Trastuzumab | — | Unknown | — | — | — |
NCT05020964CT.gov Screening Plasma HER2 Amplication by Digital PCR in Advanced Breast Cancer Patients Treated With Trastuzumab and Pyrotinib | — | Unknown | — | — | — |
NCT04963595CT.gov Pyrotinib and Vinorelbine Tartrate Capsules With or Without Inetetamab for First Line Treatment in Patients With Trastuzumab-resistant HER2-positive Advanced Breast Cancer | — | Unknown | — | — | — |
NCT04973319CT.gov Trastuzumab Combined With Pertuzumab for Adjuvant Treatment of Breast Cancer After Neoadjuvant Therapy | — | Not Yet Recruiting | — | — | — |
NCT05165225CT.gov Phase II Neoadjuvant Pyrotinib Combined with Neoadjuvant Chemotherapy in HER2-low-expressing and HR Positive Early or Locally Advanced Breast Cancer: a Single-arm, Non-randomized, Single-center, Open Label Trial | — | Active Not Recruiting | — | — | — |
NCT05292742CT.gov Compare Continuation of Original Targeted Therapy With Trastuzumab Combined With Pyrotinib and Capecitabine as Postoperative Adjuvant Therapy in Non-pCR Patients With HER2 Positive Early Breast Cancer | — | Recruiting | — | — | — |
NCT04717531CT.gov Pyrotinib as Neoadjuvant Agent for Non-objective Response HER2-positive Early Breast Cancer | — | Unknown | — | — | — |
NCT04858516CT.gov Neoadjuvant Treatment With Palbociclib and Exemestane Plus Trastuzumab and Pyrotinib in Estrogen Receptor (ER)-Positive, HER2-positive Breast Cancer | — | Unknown | — | — | — |
NCT04872985CT.gov Pyrotinib Plus Neoadjuvant Chemotherapy in HR+/HER2-, HER4-High Breast Cancer | — | Active Not Recruiting | — | — | — |
NCT04734262CT.gov A Phase II Study to Explore the Safety, Tolerability, and Preliminary Antitumor Activity of Sitravatinib Plus Tislelizumab or Combination With Nab-paclitaxel in Patients With Locally Recurrent or Metastatic Triple Negative Breast Cancer (TNBC) | — | Unknown | — | — | — |
NCT06015100CT.gov Efficacy and Safety of Inetetamab Plus Pyrotiniband and Capecitabine in HER2-positive Metastatic Breast Cancer Patients With or Without Brain Metastasis | — | Unknown | — | — | — |
NCT04736589CT.gov Inetetamab Plus Rapamycin and Chemotherapy for HER2+ Metastatic Breast Cancer With Abnormal Activation of PAM Pathway | — | Not Yet Recruiting | — | — | — |
NCT05030519CT.gov A Study of Diarrhea and Intestinal Flora Changes Caused by Pyrotinib in Breast Cancer | — | Unknown | — | — | — |
NCT04639271CT.gov Pyrotinib, Trastuzumab And Abraxane in HER2-positive MBC With Brain Metastasis | — | Unknown | — | — | — |
NCT04659499CT.gov Nab-paclitaxel in Combination With Pyrotinib in Postoperative Adjuvant Therapy for HER2-positive Breast Cancer | — | Unknown | — | — | — |
NCT04334330CT.gov Palbociclib, Trastuzumab,Pyrotinib and Fulvestrant Treatment in Patients With Brain Metastasis From ER/PR Positive, HER-2 Positive Breast Cancer: A Multi-center, Prospective Study in China | — | Unknown | — | — | — |
NCT04683445CT.gov Efficacy and Safety of Eribulin in the Treatment of Advanced Breast Cancer | — | Unknown | — | — | — |
NCT04917900CT.gov Single-arm, Multi-center Clinical Study of Pyrotinib Maleate Tablets Combined With Albumin-bound Paclitaxel and Trastuzumab in Neoadjuvant Treatment of Her2-positive Early or Locally Advanced Breast Cancer | — | Unknown | — | — | — |
NCT04646759CT.gov Fulvestrant or Capecitabine Combined With Pyrotinib in HR+/HER2+ Metastatic Breast Cancer | — | Recruiting | — | — | — |
NCT04681911CT.gov Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer | — | Unknown | — | — | — |
NCT04486911CT.gov Pyrotinib Maleate, CDK4/6 Inhibitor and Letrozole in Combination for Stage II-III TPBC: a Phase II Trial | — | Active Not Recruiting | — | — | — |
NCT06990347CT.gov A Study on the Efficacy and Safety of IPyC for HER2+ MBC | — | Completed | — | — | — |
NCT04367090CT.gov Pharmacokinetic Study of Pyrotinib and Docetaxel in Combination With Trastuzumab in Patients With HER2 Metastatic Breast Cancer | — | Completed | — | — | — |
NCT04605575CT.gov Pyrotinib Plus Vinorelbine in Participants With HER2-positive Previously Treated Locally Advanced or Metastatic Breast Cancer | — | Unknown | — | — | — |
NCT04355858CT.gov Molecularly Targeted Umbrella Study in Luminal Advanced Breast Cancer | — | Unknown | — | — | — |
NCT04293276CT.gov Study to Evaluate the Efficacy and Safety of SHR6390 Combined With Pyrotinib in HER2+ Advanced Breast Cancer | — | Unknown | — | — | — |
NCT04276493CT.gov Anti-HER2 Bispecific Antibody Zanidatamab (ZW25) Activity in Combination With Chemotherapy With/Without Tislelizumab | — | Completed | — | — | — |
NCT04290793CT.gov Neoadjuvant Chemotherapy With Pyrotinib, Epirubicin and Cyclophosphamide Followed by Taxanes and Trastuzumab for HER-2+ Breast Cancer | — | Active Not Recruiting | — | — | — |
NCT04255056CT.gov Pyrotinib in Breast Cancer Patients With Poor Response to the Neoadjuvant Treatment of Trastuzumab and Pertuzumab | — | Unknown | — | — | — |
NCT04236310CT.gov A Study of Neoadjuvant SHR6390 in Combination With Anastrozole, Pyrotinib, and Trastuzumab in Patients With ER+/HER2+ Breast Cancer. | — | Unknown | — | — | — |
NCT04246502CT.gov Capecitabine Plus Pyrotinib Versus Capecitabine Plus Trastuzumab and Pertuzumab in the First-line Treatment of HER2-positive Metastatic Breast Cancer | — | Unknown | — | — | — |
NCT04254263CT.gov Adjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer | — | Recruiting | — | — | — |
NCT04407988CT.gov Pyrotinib in Combination With Letrozole in Patients With HER2-Positive, ER-Positive Metastatic Breast Cancer | — | Unknown | — | — | — |
NCT04152057CT.gov Pyrotinib Maleate Tablets Combined With Albumin Paclitaxel and Trastuzumab for Her2-positive Breast Cancer | — | Unknown | — | — | — |
NCT04088110CT.gov Pyrotinib Combined With Trastuzumab Plus Aromatase Inhibitor in Treatment of 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 | — | — | — |
NCT04066790CT.gov Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer | — | Terminated | — | — | — |
NCT03997539CT.gov A Study of Pyrotinib Plus Vinorelbine in Comparison With Treatment of Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer | — | Unknown | — | — | — |
NCT03993964CT.gov Study to Evaluate the Efficacy and Safety of CDK4/6 Inhibitor SHR6390 Combined With Pyrotinib in the Treatment of HER2-positive Advanced Breast Cancer | — | Unknown | — | — | — |
NCT03756064CT.gov Neoadjuvant Study of Pyrotinib in Patients With HER2 Positive Breast Cancer | — | Unknown | — | — | — |
NCT04034589CT.gov Pyrotinib in Combination With Fulvestrant in Patients With HER2 Positive，HR-Positive Metastatic Breast Cancer | — | Unknown | — | — | — |
NCT03980054CT.gov A Study of Evaluating The Effects Of Pyrotinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer | — | Unknown | — | — | — |
NCT04001621CT.gov Pyrotinib in Combination With Capecitabine in Patients With Trastuzumab-resistant HER2-positive Advanced Breast Cancer | — | Unknown | — | — | — |
NCT04126525CT.gov Neoadjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer | — | Active Not Recruiting | — | — | — |
NCT03910712CT.gov Pyrotinib Combined With Trastuzumab and AI in the First-line Treatment of HER2 Positive/ HR Positive MBC | — | Unknown | — | — | — |
NCT03772353CT.gov Pyrotinib, Dalpiciclib(SHR6390) and Endocrine Therapy in Subjects With Dual-receptor Positive(ER+/HER2+) Advanced Breast Cancer | — | Unknown | — | — | — |
NCT03863223CT.gov A Study of Pyrotinib in Combination With Trastuzumab and Docetaxel in Patients With HER2 Metastatic Breast Cancer | — | Unknown | — | — | — |
NCT03923179CT.gov Phase II Clinical Study of Pyrotinib Combined With Etoposide to Treat HER2-positive Advanced Breast Cancer | — | Unknown | — | — | — |
NCT03923166CT.gov Pyrotinib Combined With Capecitabine Metronomic Therapy in HER2-postitive Advanced Breast Cancer | — | Unknown | — | — | — |
NCT03876587CT.gov Pyrotinib Combined With Docetaxel in the First-line Treatment of HER2-positive MBC | — | Unknown | — | — | — |
NCT05880927CT.gov Pyrotinib After Trastuzumab-based Adjuvant Therapy in Patients With HER2-positive Breast Cancer | — | Unknown | — | — | — |
NCT03933982CT.gov A Study of Pyrotinib Plus Vinorelbine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer | — | Unknown | — | — | — |
NCT04033172CT.gov Pyrotinib Plus Fulvestrant in Patients With HR+/HER2+ Metastatic Breast Cancer (Pyrotinib+Fulvestrant ) | — | Unknown | — | — | — |
NCT04899128CT.gov Treatment With Pyrotinib-Based Therapy in Lapatinib Resistant HER2-Positive Metastatic Breast Cancer | — | Unknown | — | — | — |
NCT03412383CT.gov Pyrotinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer | — | Unknown | — | — | — |
NCT02500199CT.gov Phase I Study of Pyrotinib in Patients With HER2-positive Solid Tumors | — | Unknown | — | — | — |
NCT02361112CT.gov Study Evaluating Pyrotinib in Combination With Capecitabine In Patients With HER2 Positive Metastatic Breast Cancer | — | Completed | — | — | — |
NCT01937689CT.gov Study of Pyrotinib in Patients With Human Epidermalgrowth Factor Receptor 2 (HER2) Positive 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 |
|---|---|---|---|
| Pyrotinib (this asset) | Fudan University | Approved | B · 63 |
| 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 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 Cancer. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 9, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/pyrotinib-breast-cancer
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