Pyrotinib

Generic Name: Pyrotinib

Drug Type: Small Molecule

Chemical Formula: C_₃₂H_₃₁ClN_₆O_₃

CAS Number: 1269662-73-8

Unique Ingredient Identifier: CJN36EQM0H

Background: Pyrotinib is under investigation in clinical trial NCT03756064 (Neoadjuvant Study of Pyrotinib in Patients With HER2 Positive Breast Cancer).

Clinical Trials

Trastuzumab Combined With Pertuzumab for Adjuvant Treatment of Breast Cancer After Neoadjuvant Therapy

Phase 3

Not yet recruiting

Conditions: Breast Cancer

Interventions: Drug: Pyrotinib
Drug: Trastuzumab

First Posted Date: 2021-07-22

Last Posted Date: 2021-07-22

Lead Sponsor: Shengjing Hospital

Target Recruit Count: 450

Registration Number: NCT04973319

Locations: 🇨🇳
Shengjing Hospital affiliated to China Medical University, Shenyang, Liaoning, China

Pyrotinib and Vinorelbine Tartrate Capsules With or Without Inetetamab for First Line Treatment in Patients With Trastuzumab-resistant HER2-positive Advanced Breast Cancer

Phase 2

Conditions: Metastatic Breast Cancer

Interventions: Drug: Pyrotinib
Drug: Vinorelbine
Drug: Inetetamab

First Posted Date: 2021-07-15

Last Posted Date: 2021-07-15

Lead Sponsor: Zhiyong Yu

Target Recruit Count: 100

Registration Number: NCT04963595

Efficacy and Safety of Pyrotinib in HER2 Positive Gastrointestinal Tumors

Phase 2

Conditions: Effect of Drug
Gastrointestinal Tumor

Interventions: Drug: Pyrotinib with or without trastuzumab

First Posted Date: 2021-07-14

Last Posted Date: 2021-07-14

Lead Sponsor: Fudan University

Target Recruit Count: 60

Registration Number: NCT04960943

Locations: 🇨🇳
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

Exploratory Study of Neoadjuvant Treatment of HER2-positive Breast Cancer With Py in Combination With HP

Phase 4

Not yet recruiting

Conditions: Breast Cancer

Interventions: Drug: Pyrotinib Maleate Tablets

First Posted Date: 2021-06-18

Last Posted Date: 2022-01-05

Lead Sponsor: Wuhan University

Target Recruit Count: 20

Registration Number: NCT04929548

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

Phase 2

Recruiting

Conditions: Breast Cancer

Interventions: Drug: Pyrotinib combined with albumin-bound paclitaxel and trastuzumab

First Posted Date: 2021-06-08

Last Posted Date: 2022-10-10

Lead Sponsor: West China Hospital

Target Recruit Count: 216

Registration Number: NCT04917900

Locations: 🇨🇳
West China Hospital, Sichuan University, Chengdu, Chengdu, Sichuan, China, China

Pyrotinib Maleate Combined With Vinorelbine in the Treatment of HER2-positive Advanced Breast Cancer

Phase 2

Completed

Conditions: HER2-positive Advanced Breast Cancer

Interventions: Drug: Pyrotinib Maleate
Drug: Vinorelbine

First Posted Date: 2021-05-26

Last Posted Date: 2022-04-07

Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Target Recruit Count: 30

Registration Number: NCT04903652

Locations: 🇨🇳
Tianjin Cancer Hospital, Tianjin, China

Pyrotinib Versus Pertuzumab in Combination With Neoadjuvant Trastuzumab and Nab-Paclitaxel in HER2+ Early or Locally Advanced Breast Cancer

Phase 2

Not yet recruiting

Conditions: HER2+ Early or Locally Advanced Breast Cancer

Interventions: Drug: pyrotinib + trastuzumab + nab-paclitaxel
Drug: pertuzumab + trastuzumab + nab-paclitaxel

First Posted Date: 2021-05-25

Last Posted Date: 2021-05-25

Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Target Recruit Count: 490

Registration Number: NCT04900311

Treatment With Pyrotinib-Based Therapy in Lapatinib Resistant HER2-Positive Metastatic Breast Cancer

Conditions: Breast Cancer

Interventions: Drug: Pyrotinib

First Posted Date: 2021-05-24

Last Posted Date: 2021-05-24

Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Target Recruit Count: 100

Registration Number: NCT04899128

Locations: 🇨🇳
Jiangsu Provincial People's Hospital, Nanjing, Jiangsu, China

Pyrotinib in Combination with Neoadjuvant Chemotherapy in HR+/HER2-, HER4 High Expression Breast Cancer Patients: a Phase II Trial

Phase 2

Recruiting

Conditions: Breast Cancer
Hormone-receptor Positive Breast Cancer

Interventions: Drug: Pyrotinib
Drug: Epirubicin
Drug: Doxorubicin Hydrochloride Liposome Injection
Drug: Cyclophosphamide
Drug: Docetaxel
Drug: Nab paclitaxel
Drug: Placebo

First Posted Date: 2021-05-05

Last Posted Date: 2024-11-04

Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Target Recruit Count: 140

Registration Number: NCT04872985

Locations: 🇨🇳
Sun-Yat-Sen Memorial Hospital of Sun-Yat-Sen University, Guangzhou, Guangdong, China

18F-FDG Uptake Heterogeneity Predicts Pyrotinib Response

Completed

Conditions: HER2-positive Breast Cancer

Interventions: Drug: Pyrotinib

First Posted Date: 2021-02-16

Last Posted Date: 2021-02-16

Lead Sponsor: Biyun Wang, MD

Target Recruit Count: 30

Registration Number: NCT04756921

Locations: 🇨🇳
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

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