A Multicenter Prospective Observational Cohort Study: Predicting Neoadjuvant Chemotherapy Response Using Pre-Treatment DCE-MRI-Based AI Models in HR+/HER2- Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Incidence of Residual Cancer Burden (RCB) 0-1
研究概览
简要总结
This study is a multicenter, prospective, observational cohort study to evaluate the predictive performance of pre-treatment DCE-MRI-based artificial intelligence (AI) models for neoadjuvant chemotherapy benefit in HR+/HER2- breast cancer. The study plans to enroll eligible HR+/HER2- breast cancer patients receiving routine standard neoadjuvant chemotherapy and stratify participants into high-benefit and low-benefit subgroups via the established AI model based on baseline breast DCE-MRI images.
All enrolled patients will undergo systematic collection of baseline clinical-pathological data, pre-treatment DCE-MRI scans, neoadjuvant chemotherapy regimens, postoperative residual cancer burden (RCB) classification, objective response rate (ORR), and long-term survival endpoints including disease-free survival (DFS) and overall survival (OS). The primary objective compares the rate of RCB 0-1 between AI-defined high-benefit patients and published historical control data; secondary analyses compare ORR, RCB 0-1 proportion, DFS and OS between AI-stratified high-benefit and low-benefit subgroups to comprehensively verify the clinical value of this imaging AI model for individualized neoadjuvant chemotherapy selection.
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
- 否
入选标准
- •Female patients aged ≥ 18 years old.
- •Histopathologically confirmed invasive breast carcinoma.
- •Hormone receptor positive (ER and/or PR ≥1%), HER2-negative status (IHC 0-1+, or IHC 2+ with negative FISH result).
- •Clinical stage II-III breast cancer per the 8th AJCC staging system, with clinical indication for neoadjuvant chemotherapy or primary surgery.
- •Standard pre-treatment breast DCE-MRI performed before neoadjuvant chemotherapy, with image quality eligible for AI model analysis.
- •ECOG performance status 0 or 1; adequate function of major vital organs to tolerate planned clinical treatment.
- •Voluntary participation with written informed consent obtained.
排除标准
- •Prior systemic anti-tumor therapy for breast cancer other than planned neoadjuvant chemotherapy.
- •Inflammatory breast cancer or distant metastatic disease (M1).
- •Concurrent active malignant tumors of other origins.
- •Contraindications to MRI examination or unqualified MRI images that cannot support model analysis.
- •Severe comorbidities incompatible with neoadjuvant chemotherapy or surgical resection.
- •Any other conditions judged ineligible for enrollment by the investigator.
研究组 & 干预措施
HR+/HER2- Breast Cancer Cohort Receiving Neoadjuvant Chemotherapy
Multicenter prospective observational cohort of patients with HR+/HER2- invasive breast cancer who receive routine standard neoadjuvant chemotherapy. All participants undergo pre-treatment DCE-MRI scanning, and an MRI-based AI model is applied to stratify patients into high and low chemotherapy benefit subgroups.
干预措施: Pre-treatment DCE-MRI-based AI model (Diagnostic Test)
结局指标
主要结局
Incidence of Residual Cancer Burden (RCB) 0-1
时间窗: After completion of neoadjuvant chemotherapy and definitive surgery (approximately 3-6 months after enrollment)
Compare the incidence of RCB 0-1 among HR+/HER2- breast cancer patients stratified as high chemotherapy benefit by pre-treatment DCE-MRI AI model against published historical control data to verify the predictive value of the imaging AI model.
次要结局
- Objective response rate (ORR) of AI-defined high neoadjuvant chemotherapy benefit group(Imaging assessment after completion of neoadjuvant chemotherapy and prior to surgery)
- Between-subgroup differences in RCB 0-1 rate(RCB classification obtained after definitive surgical resection, approximately 3-6 months after enrollment)
- Between-subgroup differences in objective response rate (ORR)(ORR imaging assessment after neoadjuvant chemotherapy before surgery)
- Disease-free survival (DFS) between high and low chemotherapy benefit subgroups(From the date of surgery until the first recurrence, metastasis, or death, whichever came first, assessed up to 60 months)
- Overall survival (OS) between high and low chemotherapy benefit subgroups(From the date of surgery until death from any cause, assessed up to 60 months)