Breast Cancer Female
Conditions
Keywords
neoadjuvant, pyrotinib, trastuzumab, paclitaxel, cisplatin
Brief summary
This is a prospective, open label study to evaluate the efficacy and safety of neoadjuvant pyrotinib in early breast cancer patients.
Interventions
DRUGPyrotinib
dual HER2 blockade in the neoadjuvant setting
Sponsors
RenJi Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pCR | 1-2 weeks after surgery | pathological complete response |
Countries
China
Outcome results
None listed