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Last Updated: December 29, 2025

CLINICAL TRIALS PROFILE FOR PYROTINIB


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Clinical Trials for pyrotinib

Trial ID Title Status Sponsor Phase Summary
NCT01937689 ↗ Study of Pyrotinib in Patients With Human Epidermalgrowth Factor Receptor 2 (HER2) Positive Advanced Breast Cancer Completed Chinese Academy of Medical Sciences Phase 1 Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is designed to evaluate the safety and tolerability of Pyrotinib in patients with HER2 positive advanced breast cancer: - To evaluate the safety and tolerability of pyrotinib, and the maximum tolerated dose (MTD) - To determine the dose-limiting toxicity (DLT) - To determine the pharmacokinetic profile of Pyrotinib and its metabolites - To assess preliminary antitumor activity - To determine preliminary regimen dose for phase II study - To explore the relationship between biomarkers and the toxicity/efficacy of Pyrotinib.
NCT01937689 ↗ Study of Pyrotinib in Patients With Human Epidermalgrowth Factor Receptor 2 (HER2) Positive Advanced Breast Cancer Completed Jiangsu HengRui Medicine Co., Ltd. Phase 1 Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is designed to evaluate the safety and tolerability of Pyrotinib in patients with HER2 positive advanced breast cancer: - To evaluate the safety and tolerability of pyrotinib, and the maximum tolerated dose (MTD) - To determine the dose-limiting toxicity (DLT) - To determine the pharmacokinetic profile of Pyrotinib and its metabolites - To assess preliminary antitumor activity - To determine preliminary regimen dose for phase II study - To explore the relationship between biomarkers and the toxicity/efficacy of Pyrotinib.
NCT02361112 ↗ Study Evaluating Pyrotinib in Combination With Capecitabine In Patients With HER2 Positive Metastatic Breast Cancer Completed Cancer Institute and Hospital, Chinese Academy of Medical Sciences Phase 1 Pyrotinib is an oral tyrosine kinase inhibitor targeting both EGFR and HER-2 receptors. This study is designed to evaluate the safety and tolerability of Pyrotinib in combination with capecitabine in patients with HER2 positive metastatic breast cancer: To evaluate the safety and tolerability of pyrotinib, and the maximum tolerated dose (MTD) To determine the dose-limiting toxicity (DLT) To determine the pharmacokinetic profile of Pyrotinib To assess preliminary antitumor activity To determine preliminary regimen dose for phase II study
NCT02361112 ↗ Study Evaluating Pyrotinib in Combination With Capecitabine In Patients With HER2 Positive Metastatic Breast Cancer Completed Jiangsu HengRui Medicine Co., Ltd. Phase 1 Pyrotinib is an oral tyrosine kinase inhibitor targeting both EGFR and HER-2 receptors. This study is designed to evaluate the safety and tolerability of Pyrotinib in combination with capecitabine in patients with HER2 positive metastatic breast cancer: To evaluate the safety and tolerability of pyrotinib, and the maximum tolerated dose (MTD) To determine the dose-limiting toxicity (DLT) To determine the pharmacokinetic profile of Pyrotinib To assess preliminary antitumor activity To determine preliminary regimen dose for phase II study
NCT02378389 ↗ Study Evaluating Pyrotinib/Pyrotinib in Combination With Docetaxel in Patients With HER2+ Advanced Gastric Cancer Unknown status Jiangsu HengRui Medicine Co., Ltd. Phase 1 Pyrotinib is an oral tyrosine kinase inhibitor targeting both EGFR and HER-2 receptors. This study is designed to evaluate the safety and tolerability of Pyrotinib or Pyrotinib in combination with Docetaxel in patients with HER2 positive advanced gastric cancer.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for pyrotinib

Condition Name

Condition Name
Intervention Trials
Breast Cancer 50
HER2-positive Breast Cancer 26
Metastatic Breast Cancer 20
Non-small Cell Lung Cancer 5
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Condition MeSH

Condition MeSH
Intervention Trials
Breast Neoplasms 112
Carcinoma, Non-Small-Cell Lung 13
Brain Neoplasms 8
Lung Neoplasms 8
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Clinical Trial Locations for pyrotinib

Trials by Country

Trials by Country
Location Trials
China 166
United States 16
Russian Federation 2
Australia 2
Taiwan 2
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Trials by US State

Trials by US State
Location Trials
Texas 2
Tennessee 2
New York 2
Florida 2
California 2
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Clinical Trial Progress for pyrotinib

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase Trials
PHASE4 3
PHASE3 2
PHASE2 20
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Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase Trials
Recruiting 69
Not yet recruiting 56
NOT_YET_RECRUITING 17
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Clinical Trial Sponsors for pyrotinib

Sponsor Name

Sponsor Name
Sponsor Trials
Jiangsu HengRui Medicine Co., Ltd. 47
Fudan University 20
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 9
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Sponsor Type

Sponsor Type
Sponsor Trials
Other 182
Industry 57
OTHER_GOV 2
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