跳至主要内容
临床试验/NCT05206396
NCT05206396招募中不适用

Do Tumor-Infiltrating Lymphocytes Predict Complete Pathologic Response to Neoadjuvant Systemic Therapy in Breast Cancer Patients?

Ain Shams University1 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2022年7月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
270
试验地点
1
主要终点
Assessment of TIL relation to pathologic complete response

研究概览

简要总结

Neoadjuvant systemic treatment for breast cancer (used in locally advanced and operable breast cancer) includes anthracycline based chemotherapy (Doxorubicin/Cyclophosphamide) followed by taxanes (weekly Paclitaxel or Docetaxel) with antiHer-2 Trastuzumab or dual antiHer-2 Trastuzumab plus Pertuzumab. Other regimens include Docetaxel plus Carboplatin plus Trastuzumab alone or combined with pertuzumab for Her-2 positive patients.

The tumor microenvironment, which includes extracellular matrix and stromal cells, is a key factor in tumorigenicity and the prediction of the efficacy of immunotherapy, conventional chemotherapy, and other anticancer therapies. Tumor-infiltrating lymphocytes (TILs), one of the most important components of the tumor microenvironment, were reported to predict the response to NAC both for tumors and axillary lymph nodes in breast cancer patients. This study is conducted to examine the relationship between tumor-infiltrating lymphocytes (categorized into three levels) and the pathologic complete response to neoadjuvant systemic therapy in breast cancer patients, and to examine the relationship between TILs and 1-year invasive disease-free survival (IDFS).

详细描述

Neoadjuvant systemic treatment for breast cancer is used in locally advanced and operable breast cancer. Standard neoadjuvant systemic therapy regimens for breast cancer patients include anthracycline based chemotherapy (Doxorubicin/Cyclophosphamide) followed by taxanes (weekly Paclitaxel or Docetaxel) with antiHer-2 Trastuzumab or dual antiHer-2 Trastuzumab plus Pertuzumab. Other regimens include Docetaxel plus Carboplatin plus Trastuzumab alone or combined with pertuzumab for Her-2 positive patients.

The tumor microenvironment, which includes extracellular matrix and stromal cells, is a key factor in tumorigenicity and the prediction of the efficacy of immunotherapy, conventional chemotherapy, and other anticancer therapies. Tumor-infiltrating lymphocytes (TILs), one of the most important components of the tumor microenvironment, were reported to predict the response to NAC both for tumors and axillary lymph nodes in breast cancer patients. This study is conducted to examine the relationship between tumor-infiltrating lymphocytes (categorized into three levels) and the pathologic complete response to neoadjuvant systemic therapy in breast cancer patients, and to examine the relationship between TILs and 1-year invasive disease-free survival (IDFS).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients aged 18 years old or more
  • Histologically proven invasive breast cancer
  • All patients diagnosed with breast cancer except T1N0 and Metastatic breast cancer
  • Patients who completed their systemic neoadjuvant therapy

排除标准

  • Second malignancy
  • Patients who started but didn't complete neoadjuvant systemic therapy
  • Patients who didn't undergo surgery after neoadjuvant systemic therapy
  • Pregnant patients

结局指标

主要结局

Assessment of TIL relation to pathologic complete response

时间窗: 1 year

TIL examined from pre-existing histopathological specimens and data of pathologic complete response will be collected from medical records

次要结局

  • 1-year disease-free interval(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Iman Aly

Professor

Ain Shams University

研究点 (1)

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