NCT06000917招募中2 期
A Multicenter, Single-arm, Prospective Study of Neoadjuvant Pyrotinib Combined With Trastuzumab，Carboplatin and Paclitaxel for ER+/HER2+ Early or Locally Advanced Breast Cancer
Wuhan Union Hospital, China2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2023年5月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- total Pathological Complete Response(tPCR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
pyrotinib,Trastuzumab，carboplatin，Albumin paclitaxel
Experimental
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
干预措施: pyrotinib,Trastuzumab，carboplatin，Albumin paclitaxel (Drug)
结局指标
主要结局
total Pathological Complete Response(tPCR)
时间窗: 2 years
次要结局
- breast Pathological Complete Response(bPCR)(2 years)
- overall response rate(ORR)(2 years)
- event-free survival(EFS)(5 years)
研究者
研究点 (2)
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