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Neoadjuvant Inituomab, Pyrrolidone and Nab-paclitaxel for HER2+Breast Cancer

2022年6月29日 更新者:Xijing Hospital

A Prospective, Open-label, Single-arm Phase II Study of Neoadjuvant Ertuzumab Combined With Pyrrolidone and Nab-paclitaxel in Patients With HER2-positive Early and Locally Advanced Breast Cancer

explore the efficacy and safety of the combination of nintedanib and paclitaxel in the neoadjuvant treatment of HER2 positive early or locally advanced breast cancer

研究概览

地位

尚未招聘

条件

详细说明

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 nituximab + pyrrolidine + nab-paclitaxel. To explore the efficacy and safety of the combination of nintedanib and paclitaxel in the neoadjuvant treatment of HER2 positive early or locally advanced breast cancer

研究类型

介入性

注册 (预期的)

20

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

有资格学习的性别

女性

描述

Inclusion Criteria:

  1. female treatment-naive patients aged ≥ 18 years and ≤ 75 years;
  2. ECOG score 0 ~ 1;
  3. 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).
  4. known hormone receptor status (ER and PgR);
  5. 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; 6. 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.

Exclusion Criteria:

  1. stage IV (metastatic) breast cancer;
  2. inflammatory breast cancer;
  3. 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;
  4. concurrent anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy or immunotherapy;
  5. Patients who have undergone major surgical procedures unrelated to breast cancer before enrollment, or have not fully recovered from such surgical procedures;
  6. severe heart disease or discomfort
  7. inability to swallow, intestinal obstruction, or other factors affecting drug administration and absorption;
  8. 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; 9. 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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Intuzumab + pyrrolidone + nab-paclitaxel

Pyrrolidone 400 mg, qd; nab-paclitaxel 125 mg/m2, qw, D1/8/15; inituzumab 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.

Pyrrolidone 400 mg, qd; nab-paclitaxel 125 mg/m2, qw, D1/8/15; inituzumab 6 mg/kg (first dose 8 mg/kg) q3w, D1; 4 cycles in total (q3w as 1 cycle).

The patient's postoperative adjuvant therapy was 4 cycles of epirubicin + cyclophosphamide + physician's choice of anti-HER2 targeted therapy.

Multiple drug interruptions for adverse events were allowed throughout.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Pathological complete response rate (pCR)
大体时间: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)
At the end of Cycle 1 (each cycle is 14 days)

次要结果测量

结果测量
措施说明
大体时间
adverse effects
大体时间:during the period of neadjuvant chemotherapy,an average of 4 weeks
Serious adverse effect occur within neoadjuvant chemotherapy
during the period of neadjuvant chemotherapy,an average of 4 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2022年11月1日

初级完成 (预期的)

2023年8月31日

研究完成 (预期的)

2023年12月31日

研究注册日期

首次提交

2022年6月26日

首先提交符合 QC 标准的

2022年6月29日

首次发布 (实际的)

2022年7月6日

研究记录更新

最后更新发布 (实际的)

2022年7月6日

上次提交的符合 QC 标准的更新

2022年6月29日

最后验证

2022年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Intuzumab, pyrrolidone, nab-paclitaxel的临床试验

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