Neoadjuvant Treatment of Pyrotinib in Combination With Trastuzumab and Abraxane in Patients With HER2-enriched Early or Locally Advanced Breast Cancer, a Single, One Arm, Multicenter II Phase Study
Breast cancer is kind of highly heterogeneous tumor. The patients with the same stage and with the same treatment regimen, their prognosis varies greatly, mainly due to the different phenotypes of breast cancer and different sensitivities to drug therapy. PMA50 and BluePrint classification divides breast cancer into other inherent subtypes: Luminal A, Luminal B, HER2-enriched (HER2-E) and Basal-like. Previous studies have shown that these patients with inherent subtype of HER2-enriched are more likely to obtain higher pCR after anti-HER2 therapy. And more study and meta analysis had demonstrated the higher pCR is closely related to EFS. The genetic and molecular typing of breast cancer is closely related to the prognosis of breast cancer, so it is imperative to seek a new treatment regimen for precision treatment and maximize the therapeutic benefit of HER2-enriched patients.
• female patients, 18 years ≤ age ≤ 75 years；
• Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
• Histologically confirmed invasive breast cancer（early stage or locally advanced）
• HER2 positive (HER2+++ by IHC or FISH+), and the HER2-enriched subtype screened by BulePrint test;
• Primary breast cancer;
• Known hormone receptor status.
• The organs are functioning normally, like the liver function, the renal function， and the baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO
• Signed informed consent form (ICF)