A Multicenter, Single-arm, Prospective Study of Neoadjuvant Pyrotinib Combined With Trastuzumab,Carboplatin and Paclitaxel for ER+/HER2+ Early or Locally Advanced Breast Cancer
This study is a multicenter, single-arm, prospective, open clinical study to evaluate the efficacy and safety of pyrotinib in combination with trastuzumab, albumin paclitaxel, and carboplatin in neoadjuvant therapy for ER+/HER2+ early or locally advanced breast cancer.
• Newly treated female patients aged ≥18 years and ≤75 years;
• ECOG score 0\
∙ 1;
• Pathologically diagnosed as HER2-positive breast cancer patients with early or locally advanced tumor stage, primary tumor diameter T≥2cm or lymph node positive;
• Hormone receptor status (ER and PgR) is known, where ER≥10%
• Normal function of major organs:
‣ The standard of blood routine examination should meet: ANC ≥1.5×109/L; PLT≥90×109/L; Hb ≥90g/L
⁃ Biochemical examination should meet the following standards: TBIL≤ the upper limit of normal value(ULN); ALT and AST≤1.5 times the upper limit of normal (ULN); Alkaline phosphatase ≤2.5 times the upper limit of normal (ULN); BUN and Cr≤1.5×ULN and creatinine clearance ≥50 mL/min (CockcroftGault formula);
⁃ Cardiac color ultrasound and echocardiography: left ventricular ejection fraction(LVEF≥55%)
⁃ Fridericia calibrated QT interval (QTcF) for 18-lead ECG \<470 ms;
• For female patients who are not menopausal or have not been surgically sterilized: consent to abstinence or use of an effective contraceptive method during treatment and for at least 7 months after the last dose in the study treatment;
• Volunteer to join the study and sign the informed consent.