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

Treatment of Dalpiciclib Combined With Pyrotinib for Trastuzumab-sensitive HER2+ Advanced Breast Cancer(DAP-Her-02)

Phase 2

Recruiting

Conditions: Breast Neoplasms

Interventions: Drug: Pyrotinib Maleate
Drug: Dalpiciclib Isethionate Tablets
Drug: Inetetamab
Drug: Fulvestrant

First Posted Date: 2022-04-14

Last Posted Date: 2023-09-25

Lead Sponsor: Henan Cancer Hospital

Target Recruit Count: 120

Registration Number: NCT05328440

Locations: 🇨🇳
Henan Cancer Hospital, Zhengzhou, Henan, China

An Exploratory Basket Study of Pyrotinib Maleate Tablets in HER2 Mutated or Amplified of Metastatic Solid Tumors

Phase 2

Conditions: Solid Tumor

Interventions: Drug: Pyrotinib Maleate
Other: standard regimen

First Posted Date: 2022-03-10

Last Posted Date: 2022-03-10

Lead Sponsor: Zhongshan Hospital Xiamen University

Target Recruit Count: 60

Registration Number: NCT05274191

Pyrotinib Plus Trastuzumab After First-line TH (P) Treatment With HER-2 Positive Breast Cancer

Phase 2

Not yet recruiting

Conditions: Advanced Breast Cancer

Interventions: Drug: pyrotinib

First Posted Date: 2022-02-24

Last Posted Date: 2022-02-24

Lead Sponsor: Fujian Medical University Union Hospital

Target Recruit Count: 60

Registration Number: NCT05255523

Effect of Montmorillonite Power or Loperamide on the Pharmacokinetics of Pyrotinib in Healthy Subjects

Phase 1

Completed

Conditions: HER2-positive Recurrent / Metastatic Breast Cancer

Interventions: Drug: pyrotinib tablet
Drug: Montmorillonite Power
Drug: Loperamide

First Posted Date: 2022-02-23

Last Posted Date: 2022-12-23

Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Target Recruit Count: 36

Registration Number: NCT05252546

Locations: 🇨🇳
Xiangya Hospital Central South University, Changsha, Hunan, China

Pyrotinib Maleate, Trastuzumab, SHR6390 and Letrozole in Combination for Stage II-III TPBC

Phase 2

Recruiting

Conditions: Breast Cancer

Interventions: Drug: Pyrotinib maleate, dalpiciclib, Trastuzumab, letrozole

First Posted Date: 2022-02-08

Last Posted Date: 2022-09-13

Lead Sponsor: Shengjing Hospital

Target Recruit Count: 12

Registration Number: NCT05228951

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

Phase 2

Active, not recruiting

Conditions: HER2-low-expressing Breast Cancer
Neoadjuvant Therapy
Breast Cancer
Hormone Receptor-positive Breast Cancer

Interventions: Drug: Pyrotinib + epirubicin and cyclophosphamide followed by docetaxel treatment

First Posted Date: 2021-12-21

Last Posted Date: 2024-11-28

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

Target Recruit Count: 48

Registration Number: NCT05165225

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

Camrelizumab Plus Pyrotinib Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Phase 2

Conditions: Gastric Neoplasms
Gastroesophageal Junction Adenocarcinoma

Interventions: Drug: Camrelizumab
Drug: Pyrotinib
Drug: Capecitabine
Drug: Oxaliplatin
Drug: Paclitaxel
Drug: S-1

First Posted Date: 2021-11-08

Last Posted Date: 2021-11-08

Lead Sponsor: Fudan University

Target Recruit Count: 65

Registration Number: NCT05111444

Locations: 🇨🇳
270 Dongan Road, Fudan University Shanghai Cancer Center, Shanghai, China

Exploratory Study of Molecular Profile-Associated Evidence Guided Precision Therapy for Salivary Gland Cancer（MAPS）

Conditions: Salivary Gland Neoplasms

Interventions: Drug: Pyrotinib
Drug: Bicalutamide
Drug: Leuprorelin

First Posted Date: 2021-10-21

Last Posted Date: 2021-10-21

Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Target Recruit Count: 182

Registration Number: NCT05087706

Locations: 🇨🇳
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai, Shanghai, China

Neoadjuvant With Trastuzumab, Pyrotinib Plus Palbociclib and Fulvestrant in HER2-positive, ER-positive Breast Cancer

Phase 2

Recruiting

Conditions: Estrogen Receptor-positive Breast Cancer
HER2-positive Breast Cancer

Interventions: Drug: Palbociclib
Drug: trastuzumab
Drug: pyrotinib
Drug: fulvestrant

First Posted Date: 2021-10-13

Last Posted Date: 2021-10-13

Lead Sponsor: Fudan University

Target Recruit Count: 37

Registration Number: NCT05076695

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

A Study of Diarrhea and Intestinal Flora Changes Caused by Pyrotinib in Breast Cancer

Conditions: Breast Cancer

First Posted Date: 2021-09-01

Last Posted Date: 2022-03-02

Lead Sponsor: Zhejiang Cancer Hospital

Target Recruit Count: 50

Registration Number: NCT05030519

Locations: 🇨🇳
China, Zhejiang, Hangzhou, China

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