Overview

Neoadjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer

Status:
Unknown status
Trial end date:
2020-09-01
Target enrollment:
0
Participant gender:
Female
Summary
This is a prospective, open label study to evaluate the efficacy and safety of neoadjuvant pyrotinib in early breast cancer patients.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
RenJi Hospital
Treatments:
Cisplatin
Paclitaxel
Trastuzumab
Criteria
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