This study is a single-arm, single-center exploratory clinical study. Twenty patients with early-stage HER2-positive breast cancer are planned to be included, and the primary objective is to evaluate the efficacy of neoadjuvant regimen of Pyrotinib in combination with trastuzumab + pertuzumab.
Female patients aged 18-70 years.
ECOG score must be 0 or 1.
Patients with clinical stage II to III new breast cancer, all diagnosed by hollow-core needle aspiration biopsy pathological histology prior to treatment and surgically resectable breast cancer with positive immunohistochemical staining (IHC) for HER2 (3+) or HER2 (2+) supplemented with fluorescence in situ hybridization technique (FISH).
The presence of at least one measurable lesion according to RECIST 1.1 criteria.
Female patients of childbearing age who are pregnant, breastfeeding, or unwilling to use effective contraception throughout the trial period.
Patients with combined severe cardiac, hepatic, renal, or endocrine system diseases and with expected survival of < 2 years for the above diseases.
Inability to swallow, intestinal obstruction, the presence of other factors affecting drug administration and absorption or a history of allergy to this drug
Karnofsky scale score below 60
Single group
Pyrotinib Maleate Tablets
DrugAddition of Pyrotinib in the EC phase to the standard treatment EC-THP regimen recommended by the guidelines.
pCR rate
Complete remission of pathology
RFS
RELAPSE-FREE SURVIVAL
OS
Overall survival
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This trial is not recruiting at the moment. You can still explore other options:
