Clinical Trials in China / NCT04126525
Active, not recruiting
Phase 2
Neoadjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer
NCT04126525 · tracked via the Priya Life Science China tracker
Condition(s) studied
Breast Cancer Female
Investigational drug(s) / intervention(s)
Pyrotinib: dual HER2 blockade in the neoadjuvant setting
Study summary
This is a prospective, open label study to evaluate the efficacy and safety of neoadjuvant pyrotinib in early breast cancer patients.
Eligibility
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
Primary outcome measure(s)
- pCR — 1-2 weeks after surgery
pathological complete response
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Renji Hospital | Shanghai | China |
More RenJi Hospital trials in China
Other trials for the same condition
Young Patients With Early Breast Cancer
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04126525 on ClinicalTrials.gov ↗ ← All trials in China