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Priya Life Science Compound trial record
Compound · clinical trials

Pyrotinib clinical trials

Also listed in trial records as SHR1258
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 51 trials in our China register that name Pyrotinib as an intervention. Synced 9 Nov 2026
51Current trials
33Recruiting now
27Lead sponsors
1Country register
At a glance

Pyrotinib is named as an intervention in 51 current clinical trials in our China register. 33 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Fudan University (6). The most-studied condition is Breast Cancer.

How Pyrotinib works

All drug targets →
  • Epidermal growth factor receptor erbB1 inhibitor Inhibitor
    Target: EGFR epidermal growth factor receptor
    ✓ In ChEMBL and the Guide to Pharmacology
  • Receptor protein-tyrosine kinase erbB-2 inhibitor Inhibitor
    Target: ERBB2 erb-b2 receptor tyrosine kinase 2
    ✓ In ChEMBL and the Guide to Pharmacology
Diseases it has been tested for in clinical trials, by furthest phase
  • Breast cancerPhase 3
  • Non-small cell lung carcinomaPhase 3
  • Biliary tract cancerPhase 2
  • CancerPhase 2
  • Colorectal cancerPhase 2
  • Esophageal adenocarcinomaPhase 2
  • Esophageal squamous cell carcinomaPhase 2
  • Gastric cancerPhase 2
  • Hepatocellular carcinomaPhase 2
  • Lung adenocarcinomaPhase 2
17 diseases in all

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL3647420, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 9662, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

Patient leaflets for Pyrotinib

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

  • UK
    United Kingdom: Search MHRA Products
    Patient information leaflets and SmPCs for UK-licensed products.
  • US
    United States: Search DailyMed
    FDA-approved labels, including patient and medication guides.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Reference identifiers for Pyrotinib

ChEMBL
CHEMBL3647420
DrugBank
DB14993
PubChem CID
51039030
CAS number
1269662-73-8
FDA UNII
CJN36EQM0H
Wikidata
Q27275495

Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.

Trials by status

  • Recruiting3365%
  • Not yet open918%
  • Active, closed918%

Trials by phase

  • Phase 22651%
  • Phase 31122%
  • Phase 1/2510%
  • Observational36%
  • Not applicable24%
  • Phase 424%
  • Phase 2/324%
01

Clinical trials of Pyrotinib

51 trials
StudyPhaseStatusLead sponsorRegisters
The Efficacy and Safety of Pyrotinib, Trastuzumab Combined With Taxanes in the Treatment of Trastuzumab-treated HER2+ Advanced Breast Cancer (ABC).
NCT06217185 · ClinicalTrials.gov ↗ · HER2-positive Breast Cancer, Advanced Breast Cancer
Phase 4 Recruiting Hebei Medical University Fourth Hospital China
Real-world Study of Pyrotinib-containing Regimens of Advanced HER2-positive Breast Cancer
NCT07600164 · ClinicalTrials.gov ↗ · HER2 + Breast Cancer, Advanced Breast Cancer
Phase 4 Recruiting Peking University People's Hospital China
Adjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer
NCT04254263 · ClinicalTrials.gov ↗ · Locally Advanced Breast Cancer
Phase 3 Recruiting RenJi Hospital China
Fulvestrant or Capecitabine Combined With Pyrotinib in HR+/HER2+ Metastatic Breast Cancer
NCT04646759 · ClinicalTrials.gov ↗ · Breast Cancer
Phase 3 Recruiting Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University China
Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive HER2-positive Breast Cancer
NCT05910398 · Breast Cancer Invasive
Phase 3 Recruiting RenJi Hospital China
Disitamab Vedotin + Pyrotinib Versus THP in the First-line Treatment for HER2+ Advanced Breast Cancer Clinical Trial
NCT06278870 · ClinicalTrials.gov ↗ · HER2-positive Metastatic Breast Cancer, First-line Treatment
Phase 3 Recruiting Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University China
Artificial Intelligence Model-Guided Neoadjuvant Anti-HER2 Targeted Therapy
NCT07528716 · ClinicalTrials.gov ↗ · Breast Cancer
Phase 3 Recruiting Fudan University China
Neoadjuvant Pyrotinib-to-pertuzumab in HER2+ eBC
NCT07797218 · ClinicalTrials.gov ↗ · Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Phase 3 Recruiting Shanghai Jiao Tong University School of Medicine China
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
NCT06958627 · ClinicalTrials.gov ↗ · HER2 Positive Breast Cancer, Pyrotinib Treatment
Phase 2/3 Recruiting Cancer Institute and Hospital, Chinese Academy of Medical Sciences China
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
NCT05292742 · ClinicalTrials.gov ↗ · Breast Cancer, Adjuvant Therapy
Phase 2 Recruiting Fujian Medical University Union Hospital China
Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy
NCT05582499 · ClinicalTrials.gov ↗ · Breast Neoplasm, Breast Cancer, Breast Tumors
Phase 2 Recruiting Fudan University China
A Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients
NCT05635487 · ClinicalTrials.gov ↗ · HER2-positive Breast Cancer
Phase 2 Recruiting Shengjing Hospital China
Pyrotinib Combined With Trastuzumab, Dalpiciclib, Letrozole Versus TCbHP (Trastuzumab Plus Pertuzumab With Docetaxel and Carboplatin) as Neoadjuvant Treatment in HR +/HER2 + Breast Cancer
NCT05638594 · ClinicalTrials.gov ↗ · Breast Cancer
Phase 2 Recruiting Shengjing Hospital China
Phase II Clinical Study of Pyrotinib in First-line Treatment of Primary HER2-amplified/Mutated Advanced Non-small Cell Lung Cancer
NCT05751018 · ClinicalTrials.gov ↗ · Non-small Cell Lung Cancer
Phase 2 Recruiting Peking Union Medical College Hospital China
Study of SHR-A1811 in HER2-expression Advanced Breast Cancer With Brain Metastases
NCT05769010 · ClinicalTrials.gov ↗ · Metastatic Breast Cancer
Phase 2 Recruiting Henan Cancer Hospital China
Pyrotinib in Women With High-risk in Early Stage Breast Cancer
NCT05834764 · ClinicalTrials.gov ↗ · HER2-positive Breast Cancer
Phase 2 Recruiting The First Affiliated Hospital with Nanjing Medical University China
Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer
NCT05861271 · ClinicalTrials.gov ↗ · Breast Cancer Stage I
Phase 2 Recruiting Fudan University China
Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing
NCT06145308 · ClinicalTrials.gov ↗ · Salivary Gland Carcinoma, Precision Therapy
Phase 2 Recruiting Peking Union Medical College China
Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.
NCT06563999 · ClinicalTrials.gov ↗ · Lung Cancer Stage III, Mutation
Phase 2 Recruiting Sun Yat-sen University China
Study of Dalpiciclib Isethionate Plus Pyrotinib Maleate in the Treatment of Advanced Esophageal Squamous Cell Carcinoma
NCT06684600 · ClinicalTrials.gov ↗ · Esophageal Squamous Cell Carcinoma
Phase 2 Recruiting Peking University China
RC48 Plus Bevacizumab or Pyrotinib in HER2-Positive Metastatic Breast Cancer After T-DXd Failure: A Phase II Study
NCT07065435 · ClinicalTrials.gov ↗ · HER2 + Breast Cancer
Phase 2 Recruiting The First Affiliated Hospital with Nanjing Medical University China
Continuous or Intermittent Pyrotinib for HER2-positive Advanced Breast Cancer
NCT07180082 · ClinicalTrials.gov ↗ · Advanced Breast Cancer
Phase 2 Recruiting Wenjin Yin China
ctDNA in HER2+ EBC Neoadjuvant Treatment
NCT07335081 · ClinicalTrials.gov ↗ · Breast Cancer
Phase 2 Recruiting Shanghai Jiao Tong University School of Medicine China
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
NCT07340398 · ClinicalTrials.gov ↗ · HER2-positive Early Breast Cancer
Phase 2 Recruiting Second Affiliated Hospital, Zhejiang University, School of Medicine China
Neoadjuvant Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab in HER2+ Breast Cancer
NCT07393425 · ClinicalTrials.gov ↗ · HER2 + Breast Cancer
Phase 2 Recruiting Shanghai Jiao Tong University School of Medicine China
Dalpiciclib, Anti-HER2 Therapy, and Endocrine Therapy for Hormone-Receptor-Positive, HER2-Positive Metastatic Breast Cancer
NCT07610720 · ClinicalTrials.gov ↗ · Advanced/Metastatic Breast Cancer, HER2-Positive Metastatic Breast Cancer
Phase 2 Recruiting Sun Yat-sen University China
GQ1001 Combined With Pyrotinib for Treatment With HER2 Positive Metastatic Breast Cancer
NCT05575804 · ClinicalTrials.gov ↗ · Advanced/ Metastatic Her-2 Positive Breast Cancer
Phase 1/2 Recruiting Fudan University China
A Trial of SHR-A1811 Combined With Other Antitumor Therapies in Advanced Solid Tumors.
NCT06015048 · ClinicalTrials.gov ↗ · HER2-expressing Advanced Solid Tumors
Phase 1/2 Recruiting Jiangsu HengRui Medicine Co., Ltd China
Study of SHR-A1811 Combined With Pyrotinib and Bevacizumab in Advanced Breast Cancer With Brain Metastasis
NCT06718933 · ClinicalTrials.gov ↗ · Breast Cancer Metastatic, Breast Cancer Brain Metastases
Phase 1/2 Recruiting Fudan University China
Entinostat Plus Pyrotinib and Endocrine Therapy in Advanced Triple-Positive Breast Cancer After Trastuzumab Failure
NCT07708194 · ClinicalTrials.gov ↗ · Breast Cancer, HER2-positive Breast Cancer, Hormone Receptor-Positive Breast Cancer
Phase 1/2 Recruiting Tianjin Medical University Cancer Institute and Hospital China
Pyrotinib Plus Capecitabine for Adjuvant Treatment of HER2 Positive Early-stage Breast Cancer
NCT06035016 · ClinicalTrials.gov ↗ · HER2-positive Breast Cancer, Early-stage Breast Cancer
Observational Recruiting Peking Union Medical College Hospital China
Pyrotinib Combined With Trastuzumab for Maintenance Therapy After First-line TH (P) Therapy for HER2+ABC
NCT06754059 · ClinicalTrials.gov ↗ · HER2-positive Breast Cancer
Observational Recruiting zhangjie China
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
NCT06234137 · ClinicalTrials.gov ↗ · Breast Neoplasm Female
Not applicable Recruiting Wang Ouchen China
Inetetamab Plus Rapamycin and Chemotherapy for HER2+ Metastatic Breast Cancer With Abnormal Activation of PAM Pathway
NCT04736589 · ClinicalTrials.gov ↗ · Breast Cancer
Phase 3 Not yet open Peking Union Medical College China
Trastuzumab Combined With Pertuzumab for Adjuvant Treatment of Breast Cancer After Neoadjuvant Therapy
NCT04973319 · ClinicalTrials.gov ↗ · Breast Cancer
Phase 3 Not yet open Shengjing Hospital China
Trastuzumab Rezetecan Followed by Pyrotinib, Fulvestrant, and Dalpiciclib in HR-Positive, HER2-Positive Advanced Breast Cancer
NCT07892274 · ClinicalTrials.gov ↗ · Metastatic Breast Cancer (MBC), HER2-Positive Breast Cancer, Hormone Receptor-Positive Breast Cancer
Phase 3 Not yet open Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University China
A Prospective, Open-label, Exploratory Basket Trial to Evaluate the Efficacy and Safety of Sintilimab Combined With Pyrotinib ± Chemotherapy in Patients With Advanced Digestive System Tumors
NCT07053150 · ClinicalTrials.gov ↗ · Advanced Digestive System Tumor
Phase 2 Not yet open Tongji Hospital China
Maintenance Therapy in HER2-Positive Unresectable Locally Recurrent or Metastatic Breast Cancer: A Phase II Study
NCT07179939 · ClinicalTrials.gov ↗ · HER2-positive Breast Cancer
Phase 2 Not yet open Fudan University China
Trastuzumab Rezetecan Followed by Pyrotinib, and Trastuzumab Combined With Capecitabine as First-line Treatment for Advanced HER2-positive Breast Cancer
NCT07766772 · ClinicalTrials.gov ↗ · HER2 + Breast Cancer, Advanced Breast Cancer
Phase 2 Not yet open Fujian Cancer Hospital China
A Phase II Study of Trastuzumab Deruxtecan (T-DXd) Plus Pyrotinib in HER2-Positive Advanced Breast Cancer After Progression on T-DXd
NCT07836257 · ClinicalTrials.gov ↗ · Breast Cancer
Phase 2 Not yet open Fujian Medical University China
A Study of RC48-ADC Combined With Pyrotinib For Treatment of Local Advanced or Metastasis NSCLC With HER2 Mutation
NCT05745740 · ClinicalTrials.gov ↗ · Non-small Cell Lung Cancer
Phase 1/2 Not yet open RemeGen Co., Ltd China
Efficacy and Safety of Disitamab Vedotin Plus Pyrotinib or Naratinib in HER2-positive Breast Cancer Patients With Brain Metastasis
NCT06015113 · ClinicalTrials.gov ↗ · Breast Cancer
Not applicable Not yet open Xi'an International Medical Center Hospital China
A Study of Evaluating The Effects Of Pyrotinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
NCT03980054 · ClinicalTrials.gov ↗ · Breast Cancer
Phase 3 Active, closed Jiangsu HengRui Medicine Co., Ltd China
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
NCT05424835 · ClinicalTrials.gov ↗ · HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane
Phase 3 Active, closed Jiangsu HengRui Medicine Co., Ltd China
Neoadjuvant Chemotherapy With Pyrotinib, Epirubicin and Cyclophosphamide Followed by Taxanes and Trastuzumab for HER-2+ Breast Cancer
NCT04290793 · ClinicalTrials.gov ↗ · Breast Cancer
Phase 2/3 Active, closed Hebei Medical University Fourth Hospital China
Neoadjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer
NCT04126525 · ClinicalTrials.gov ↗ · Breast Cancer Female
Phase 2 Active, closed RenJi Hospital China
Pyrotinib, Trastuzumab, Pertuzumab and Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
NCT04398914 · ClinicalTrials.gov ↗ · Breast Cancer Invasive
Phase 2 Active, closed Shanghai Jiao Tong University School of Medicine China
Pyrotinib Plus Neoadjuvant Chemotherapy in HR+/HER2-, HER4-High Breast Cancer
NCT04872985 · ClinicalTrials.gov ↗ · Breast Cancer, Hormone-receptor Positive Breast Cancer
Phase 2 Active, closed Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University China
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
NCT05165225 · ClinicalTrials.gov ↗ · Breast Cancer, HER2-low-expressing Breast Cancer, Hormone Receptor-positive Breast Cancer
Phase 2 Active, closed Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University China
Treatment of Dalpiciclib Combined With Pyrotinib for Trastuzumab-sensitive HER2+ Advanced Breast Cancer(DAP-Her-02)
NCT05328440 · ClinicalTrials.gov ↗ · Breast Neoplasms
Phase 2 Active, closed Henan Cancer Hospital China
Pyrotinib for HER2-Positive Advanced Breast Cancer Previously Treated With Trastuzumab and Pertuzumab
NCT07810634 · ClinicalTrials.gov ↗ · Breast Cancer
Observational Active, closed Beijing 302 Hospital China

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Conditions studied with Pyrotinib

43 conditions
All 43 conditions
Condition (as registered)Trials
Breast Cancer16
HER2-positive Breast Cancer7
Advanced Breast Cancer4
HER2 + Breast Cancer4
Metastatic Breast Cancer2
Hormone Receptor-Positive Breast Cancer2
Non-small Cell Lung Cancer2
Breast Cancer Invasive2
Breast Neoplasm Female1
Salivary Gland Carcinoma1
Precision Therapy1
Esophageal Squamous Cell Carcinoma1
Lung Cancer Stage III1
Mutation1
HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane1
Breast Cancer Metastatic1
Breast Cancer Brain Metastases1
Breast Neoplasm1
Breast Tumors1
Triple-Negative Breast Cancer (TNBC)1
Advanced/ Metastatic Her-2 Positive Breast Cancer1
HER2-positive Early Breast Cancer1
HER2 Positive Breast Cancer1
Pyrotinib Treatment1
HER2-low-expressing Breast Cancer1
Hormone Receptor-positive Breast Cancer1
Neoadjuvant Therapy1
Breast Cancer Stage I1
Hormone-receptor Positive Breast Cancer1
Advanced/Metastatic Breast Cancer1
HER2-Positive Metastatic Breast Cancer1
Breast Cancer Female1
Metastatic Breast Cancer (MBC)1
HER2-Positive Breast Cancer1
HER2-positive Metastatic Breast Cancer1
First-line Treatment1
Breast Neoplasms1
Locally Advanced Breast Cancer1
Advanced Digestive System Tumor1
Early-stage Breast Cancer1
HER2-expressing Advanced Solid Tumors1
Adjuvant Therapy1
Breast Cancer Early Stage Breast Cancer (Stage 1-3)1
05

Related compounds

06

Questions about Pyrotinib trials

How many clinical trials are testing Pyrotinib?

51 current trials in our China register name Pyrotinib (also registered as SHR1258) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.

Are Pyrotinib trials recruiting patients?

Yes. 33 of the 51 trials are recruiting: 33 with sites in China. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Pyrotinib clinical trials?

Fudan University (6), Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (5), Shanghai Jiao Tong University School of Medicine (4) and Shengjing Hospital (3), among 27 lead sponsors in total. The number in brackets is how many trials each organisation leads.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Pyrotinib works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Pyrotinib works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Pyrotinib (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.