65 unknown, 36 recruiting, 24 not yet recruiting, 12 completed. 99 Phase 2, 23 Phase 3, 16 Phase 1, 8 Not applicable, 2 Phase 4.
Follow pyrotinib: new trials by email Literature Review of pyrotinib trials Research Report on pyrotinib
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study of RC48-ADC Combined With Pyrotinib For Treatment of Local Advanced or Metastasis NSCLC With HER2 Mutation RC48-ADC, Pyrotinib - Non-small Cell Lung Cancer | Phase 1 / Phase 2 | Not yet recruiting | RemeGen Co., Ltd. | 26 | 2027-12-01 | 2026-09-22 |
| Trastuzumab Rezetecan Followed by Pyrotinib, Fulvestrant, and Dalpiciclib in HR-Positive, HER2-Positive Advanced Breast Cancer Fulvestrant, Pyrotinib, Dalpiciclib - Metastatic Breast Cancer (MBC), HER2-Positive Breast Cancer | Phase 3 | Not yet recruiting | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | 226 | 2026-11-01 | 2026-10-23 |
| A Phase II Study of Trastuzumab Deruxtecan (T-DXd) Plus Pyrotinib in HER2-Positive Advanced Breast Cancer After Progression on T-DXd Trastuzumab Deruxtecan (T-DXd), Pyrotinib - Breast Cancer | Phase 2 | Not yet recruiting | Fujian Medical University | 28 | 2026-10-10 | 2026-09-23 |
| Trastuzumab Rezetecan Followed by Pyrotinib, and Trastuzumab Combined With Capecitabine as First-line Treatment for Advanced HER2-positive Breast Cancer Trastuzumab Rezetecan, Pyrotinib, trastuzumab - HER2 + Breast Cancer, Advanced Breast Cancer | Phase 2 | Not yet recruiting | Fujian Cancer Hospital | 50 | 2026-09-30 | 2026-08-14 |
| Pyrotinib for HER2-Positive Advanced Breast Cancer Previously Treated With Trastuzumab and Pertuzumab Pyrotinib 400mg - Breast Cancer | Active not recruiting | Beijing 302 Hospital | 200 | 2026-09-02 | 2026-09-09 | |
| Real-world Study of Pyrotinib-containing Regimens of Advanced HER2-positive Breast Cancer Pyrotinib, Trastuzumab Rezetecan - HER2 + Breast Cancer, Advanced Breast Cancer | Phase 4 | Recruiting | Peking University People's Hospital | 500 | 2026-07-06 | 2026-07-13 |
| Neoadjuvant Pyrotinib-to-pertuzumab in HER2+ eBC Docetaxel, Pyrotinib, Trastuzumab (Herceptin) - Breast Cancer Early Stage Breast Cancer (Stage 1-3) | Phase 3 | Recruiting | Shanghai Jiao Tong University School of Medicine | 220 | 2026-07-01 | 2026-09-01 |
| Precision Medicine for Immunotherapy-Resistant Advanced Esophageal Cancer Afatinib + Toripalimab, Dalpiciclib + Pyrotinib, Camrelizumab + Apatinib - Esophageal Squamous Cell Carcinoma | Phase 2 / Phase 3 | Not yet recruiting | Peking University Cancer Hospital & Institute | 90 | 2026-07-01 | 2026-06-17 |
| Dalpiciclib, Anti-HER2 Therapy, and Endocrine Therapy for Hormone-Receptor-Positive, HER2-Positive Metastatic Breast Cancer Dalpiciclib, Trastuzumab (Herceptin), Pertuzumab - Advanced/Metastatic Breast Cancer, HER2-Positive Metastatic Breast Cancer | Phase 2 | Recruiting | Sun Yat-sen University | 57 | 2026-06-01 | 2026-05-28 |
| The Real World Study of Pyrotinib in the Treatment of Advanced Breast Cancer With HER2 Positive Pyrotinib - Breast Cancer, RWS | Not applicable | Not yet recruiting | Tianjin Medical University Cancer Institute and Hospital | 500 | 2026-04-01 | 2026-03-20 |
| SHR-A1811 vs Pyrotinib/Capecitabine in Trastuzumab-Resistant HER2+ Advanced Breast Cancer: A Randomized Study SHR-A1811, Pyrotinib, Capecitabine - Breast Cancer, HER2-positive Breast Cancer | Phase 2 | Not yet recruiting | Peking University Cancer Hospital & Institute | 100 | 2026-03-31 | 2026-02-18 |
| Pyrotinib Combined With Trastuzumab and Pertuzumab for Maintenance Therapy in HER2-Positive Advanced Breast Cancer Pyrotinib, Trastuzuma, Pertuzumab - HER2-positive Breast Cancer | Not yet recruiting | Peking University Cancer Hospital & Institute | 42 | 2026-03-31 | 2026-03-13 | |
| Neoadjuvant Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab in HER2+ Breast Cancer Trastuzumab Deruxtecan, Pertuzumab, Taxane Chemotherapy - HER2 + Breast Cancer | Phase 2 | Recruiting | Shanghai Jiao Tong University School of Medicine | 50 | 2026-02-02 | 2026-02-06 |
| 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 Nab paclitaxel, Carboplatin, Trastuzumab - HER2-positive Early Breast Cancer | Phase 2 | Recruiting | Second Affiliated Hospital, Zhejiang University, School of Medicine | 200 | 2025-12-25 | 2026-01-21 |
| 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 SHR- A1811 - SHR-A1811, HER2-Postive Breast Cancer | Phase 2 | Not yet recruiting | Tianjin Medical University Cancer Institute and Hospital | 30 | 2025-12-20 | 2025-12-29 |
| Maintenance Therapy in HER2-Positive Unresectable Locally Recurrent or Metastatic Breast Cancer: A Phase II Study Trastuzumab rezetecan, Pyrotinib, Dalpiciclib - HER2-positive Breast Cancer | Phase 2 | Not yet recruiting | Fudan University | 288 | 2025-09-10 | 2025-09-18 |
| This Study Aims to Optimize Neoadjuvant Therapy for HER2-positive Breast Cancer by Implementing a Dynamic Monitoring-guided Treatment Strategy. Patients will initially receive trastuzumab, pyrotinib, and albumin-bound paclitaxel. Those who do not achieve a radiological response after Cycle 2 will switch to SHR-A1811 (a HER2-targeted antibody, Patients will initially receive trastuzumab, pyrotinib, and nab-paclitaxel. Those who achieve a partial response (PR) or complete response (CR) after cycle 2 will continue on the same regimen. - HER2-positive Breast Cancer | Phase 2 | Not yet recruiting | Hebei Medical University Fourth Hospital | 30 | 2025-09-01 | 2025-08-05 |
| SHR-A1811 Combine With Pyrotinib for Locally Advanced/Metastatic HER2 Positive Breast Cancer SHR-A1811 4.0mg/kg, Pyrotinib 240mg, SHR-A1811 4.8mg/kg - Metastatic Breast Cancer With HER2 Positive | Phase 2 | Not yet recruiting | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | 84 | 2025-08-30 | 2025-08-20 |
| Continuous or Intermittent Pyrotinib for HER2-positive Advanced Breast Cancer Pyrotinib - Advanced Breast Cancer | Phase 2 | Recruiting | Wenjin Yin | 186 | 2025-08-28 | 2025-11-18 |
| 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 Sintilimab, Pyrotinib, Optional Chemotherapy - Advanced Digestive System Tumor | Phase 2 | Not yet recruiting | Tongji Hospital | 80 | 2025-08-15 | 2025-07-08 |
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Breast Neoplasms (79) · Carcinoma, Non-Small-Cell Lung (6) · Brain Neoplasms (4) · Breast Diseases (4) · Colorectal Neoplasms (2) · Esophageal Squamous Cell Carcinoma (2) · Salivary Gland Neoplasms (2) · Stomach Neoplasms (2) · Triple Negative Breast Neoplasms (2) · Carcinoma, Transitional Cell (1) · Digestive System Neoplasms (1) · Lung Neoplasms (1) · Neoplasm Metastasis (1) · Pathologic Complete Response (1)
Fudan University (16) · Jiangsu HengRui Medicine Co., Ltd. (15) · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (8) · The First Affiliated Hospital with Nanjing Medical University (8) · Henan Cancer Hospital (7) · Tianjin Medical University Cancer Institute and Hospital (7) · Chinese Academy of Medical Sciences (6) · Sun Yat-sen University (6) · Cancer Institute and Hospital, Chinese Academy of Medical Sciences (5) · Shanghai Jiao Tong University School of Medicine (5) · Hebei Medical University Fourth Hospital (3) · Peking Union Medical College (3) · Peking Union Medical College Hospital (3) · Peking University Cancer Hospital & Institute (3) · RenJi Hospital (3)
China (121) · United States (2) · Australia (1) · Belgium (1) · France (1) · Germany (1) · Italy (1) · Poland (1) · Russia (1) · South Korea (1) · Spain (1) · Taiwan (1) · Turkey (Türkiye) (1)
Binghe Xu (2) · Hongxia Wang, Chief physician (2) · Jinsong Lu (2) · Min Yan (2) · Wenjin Yin, M.D. (2) · Xuexin He, MD (2) · Ying Wang (2) · Biyun Wang, Chief physician (1) · Cai-Gang Liu, MD (1) · Caicun Zhou, MD,PhD (1) · Caigang Liu, MD (1) · Chang Gong, Prof (1) · Chen Xi, PhD (1)
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