Neoadjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer (NeoATP)

Shanghai Jiao Tong University

Status and phase

Active, not recruiting

Phase 2

Conditions

Breast Cancer Female

Treatments

Drug: Pyrotinib

Study type

Interventional

Funder types

Other

Identifiers

KY2019-023

Details and patient eligibility

About

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

Enrollment

53 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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
ECOG 0-1
Adequate organ function

Exclusion criteria

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