A Prospective, Open-label, Single-arm Phase II Study of Neoadjuvant Inetetamab Combined With Pyrotinib and Nab-paclitaxel in Patients With HER2-positive Early and Locally Advanced Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pathological complete response rate (pCR)
研究概览
简要总结
Explore the efficacy and safety of the combination of inetetamab, pyrotinib and nab-paclitaxel in the neoadjuvant treatment of HER2 positive early or locally advanced breast cancer
详细描述
This study is a prospective, open-label, single-arm clinical study, and it is planned to include 20 treatment-naive patients with HER2-positive early or locally advanced breast cancer (clinical stage IIA ~ IIIC). Neoadjuvant treatment regimen was inetetamab + pyrotinib + nab-paclitaxel. To explore the efficacy and safety of the combination of inetetamab,pyrotinib and nab-paclitaxel in the neoadjuvant treatment of HER2 positive 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
- •female treatment-naive patients aged ≥ 18 years and ≤ 75 years;
- •ECOG score 0 ~ 1;
- •HER2-positive breast cancer confirmed by pathological examination, defined as an immunohistochemical (IHC) score of 3 + in > 10% of immunoreactive cells or HER2 gene amplification by in situ hybridization (ISH) results (HER2 gene signal to centromere 17 signal ratio ≥ 2.0 or HER2 gene copy number ≥ 6).
- •known hormone receptor status (ER and PgR);
- •The functional level of major organs must meet the following requirements (no blood transfusion, no leukocyte-elevating and platelet-elevating drugs are used 2 before screening):
- •1) Blood routine neutrophil (ANC) ≥ 1.5 × 109/L; platelet count (PLT) ≥ 90 × 109/L; hemoglobin (Hb) ≥ 90 g/L; 2) Blood biochemical total bilirubin (TBIL) ≤ upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; blood urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN; 3) echocardiography score (LVEF) ≥ 55%; 4) 12 ECG Fridericia-corrected QT interval (QTcF) < 470 msec;
- •For premenopausal or non-surgically sterile female patients: agree to abstain from sexual intercourse or use effective contraceptive methods during treatment and for at least 7 months after the last dose of the study treatment.
- •7. Voluntarily join this study, sign the informed consent form, have good compliance and are willing to cooperate with the follow-up.
排除标准
- •stage IV (metastatic) breast cancer;
- •inflammatory breast cancer;
- •Previous anti-tumor therapy or radiotherapy for any malignant tumor, excluding cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma and other malignant tumors;
- •concurrent anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy or immunotherapy;
- •Patients who have undergone major surgical procedures unrelated to breast cancer before enrollment, or have not fully recovered from such surgical procedures;
- •severe heart disease or discomfort
- •inability to swallow, intestinal obstruction, or other factors affecting drug administration and absorption;
- •known to have a history of allergy to the drug components of this protocol: a history of immunodeficiency, including HIV test positive, or suffering from other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;
- •pregnant and lactating female patients, female patients with fertility and positive baseline pregnancy test, or patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial and within 7 months after the study;
- •10. suffering from serious concomitant diseases or other diseases that will interfere with the planned treatment of concomitant diseases, or any other conditions that the investigator believes that the patient is not suitable for this study
研究组 & 干预措施
Inetetamab + pyrotinib + nab-paclitaxel
pyrotinib 400 mg, qd; nab-paclitaxel 125 mg/m2, qw, D1/8/15; Inetetamab 6 mg/kg (first dose 8 mg/kg) q3w, D1; 4 cycles in total (q3w as 1 cycle).
Postoperative adjuvant therapy:4 cycles of epirubicin + cyclophosphamide + physician's choice of anti-HER2 targeted therapy.
干预措施: Inetetamab, pyrotinib, nab-paclitaxel (Drug)
结局指标
主要结局
Pathological complete response rate (pCR)
时间窗: At the end of Cycle 1 (each cycle is 14 days)
absence of invasive carcinoma in the breast and axillary lymph nodes, while residual ductal carcinoma in situ was accepted (ypT0orTisypN0)
次要结局
- Objective response rate (ORR)(During the period of neadjuvant treatment, an average of 4 weeks)
- adverse effects(during the period of neadjuvant treatment, an average of 4 weeks)