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临床试验/NCT04909554
NCT04909554已完成不适用

MRI-based Approaches for Multi-parametric Model to Early Predict Pathological Complete Response to Neoadjuvant Chemotherapy in Breast Cancer (NeoMDSS)

Guangdong Provincial People's Hospital1 个研究点 分布在 1 个国家目标入组 301 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
301
试验地点
1
主要终点
Sensitivity

研究概览

简要总结

The purpose of this clinical research is to evaluate the accuracy of a multi-parametric model based on magnetic resonance imaging (MRI) in predicting pathological complete response (pCR) after the first cycle of neoadjuvant therapy (NAT) given to patients with locally advanced breast cancer, thus allowing early chemotherapy regimen modification to increase number of patients achieving pCR or save patients from toxic effects of ineffective chemotherapy.

详细描述

Breast cancer is the most prevalent cancer among women worldwide. NAT has been well established in managing breast cancer for patients with locally advanced cancer and early-stage operable breast cancers of specific molecular subtypes. Though pCR has been demonstrated to be associated with better survival, it can only be judged by pathological testing of surgically resected specimens. Thus, predicting pCR earlier during NAT is imperative and can timely switch to a new personalized treatment strategy and exempt from unnecessary chemotherapy toxicity for patients.

This is a multicenter, prospective cohort study of 301 patients undergoing MRI after the first cycle of neoadjuvant chemotherapy. This project plans to establish and validate a model for determining pCR during NAT in breast cancer based on clinical information, imaging and pathological information of patients in multiple centers, in order to provide important references for further early diagnosis and personalized treatment.

  1. Collecting MRI images data, clinical and pathological information, treatment regimens, and curative effect information to build an MRI-based, multi-parametric model.
  2. Evaluating the performance of model through internal and external validation cohort by using the receiver operating characteristic (ROC) curve, the area under the curve (AUC), discrimination and calibration measures.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Age ≥18 years;
  • Histologically confirmed invasive breast carcinoma;
  • Clinical stage II-III at presentation;
  • Complete basic information and image data;
  • Have MRI imaging data at baseline and after the first cycle of NAC;
  • Finish the standard NAC treatment and undergo surgery;

排除标准

  • With chemotherapy contraindications;
  • Multifocal of multicentric lesions;
  • Poor quality of MRI images;
  • For validation cohort:
  • Inclusion Criteria:
  • Age ≥18 years;
  • Complete basic information and image data;
  • Clinical stage II-III at presentation;
  • Scheduled for neoadjuvant chemotherapy;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-
  • Signed informed consent;
  • Exclusion Criteria:
  • With chemotherapy contraindications;
  • Metastatic breast cancer;
  • Multifocal of multicentric lesions;

结局指标

主要结局

Sensitivity

时间窗: up to 28 weeks

Testing the sensitivity of NeoMDSS model to predict pCR using the area under receiver operating characteristic curve.

次要结局

  • Specificity(up to 6 weeks)

研究者

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

Kun Wang

Professor

Guangdong Provincial People's Hospital

研究点 (1)

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