A Study of Neoadjuvant TCHpy(Pyrotinib ,Trastuzumab,Carboplatin and Paclitaxel)for ER+/HER2+ Breast Cancer
Breast Cancer, Neoadjuvant
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Stage IV (metastatic) breast cancer; Inflammatory breast cancer; Previous antitumor therapy or radiation therapy for any malignancies, excluding cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma; Also receiving antitumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy, or immunotherapy; Had a major surgery not related to breast cancer in the 4 weeks prior to enrollment, or had not fully recovered from such surgery; Serious heart disease or discomfort, including but not limited to the following: History of heart failure or systolic dysfunction (LVEF < 50%) High-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate >100 bpm, significant ventricular arrhythmias (such as ventricular tachycardia), or higher-grade atrioventricular block (i.e. Mobitz II second- degree atrioventricular block or third-degree atrioventricular block Inability to swallow, intestinal obstruction, or other factors affecting the use and absorption of the drug; Known allergic history of the drug components of this protocol; A history of immunodeficiency, including HIV testing positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation; Women who are pregnant or nursing, women who are fertile and have a positive baseline pregnancy test, or women of childbearing age who are unwilling to use effective contraception throughout the trial period and within 7 months after the last study medication; Have a serious concomitant condition or other comorbid condition that interferes with planned treatment, or any other condition in which the investigator deems the patient unsuitable for participation in the study.
Sites / Locations
- WuhanHURecruiting
- Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
Arms of the Study
Arm 1
Experimental
pyrotinib,Trastuzumab,carboplatin,Albumin paclitaxel
Pyrotinib tablets: 320mg qd, 21 days for 1 cycle, continuous administration of 6 cycles. Trastuzumab: The first cycle was 8mg/kg, the second to sixth cycle was 6mg/kg, 21 days was 1 cycle, continuous administration of 6 cycles. Albuminpaclitaxel: On the first day of cycle 1, 260mg/m2 was given intravenously, 21 days for 1 cycle, and 6 consecutive cycles were given. Carboplatin: Endogenous creatinine clearance was calculated using the Cockcroft formula, with AUC 5 for the 1st to 6th cycle and 1 cycle for the 21st day and 6 consecutive cycles of administration