NeoAdjuvant Trastuzumab/ Pyrotinib Plus Weekly Paclitaxel/Cisplatin in HER2-positive Locally Advanced Breast Cancer Patients

RenJi Hospital1 site in 1 country53 target enrollmentJune 18, 2019

InterventionsPyrotinib

Overview

This is a prospective, open label study to evaluate the efficacy and safety of neoadjuvant pyrotinib in early breast cancer patients.

Registry

clinicaltrials.gov

Start Date

June 18, 2019

End Date

November 1, 2026

Last Updated

7 months ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Sponsor

Responsible Party

Principal Investigator

Wenjin Yin

Deputy Chief of Breast Surgery Department

RenJi Hospital

•Female, Aged ≥18 and ≤70 years
•Histologically confirmed invasive HER2 positive breast cancer, early disease(Stage ⅡA-Ⅲ)
•Subjects with at least one evaluable lesion
•Adequate organ function

•Metastatic disease (Stage IV)
•Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption
•Treated or treating with T-DM1, lapatinib and neratinib before study entry
•History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation
•Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial
•Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test. Female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period
•Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study