跳至主要内容
临床试验/NCT05914402
NCT05914402招募中不适用

Axillary Surgery De-escalation After Neoadjuvant Therapy (NeoaPET) Using a Dedicated Breast PET-based Pathological Response-adapted Strategy in Patients With Axillary-positive Early Breast Cancer

Fudan University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年6月18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
100
试验地点
1
主要终点
Node Recurrence Rate

研究概览

简要总结

Some breast cancer patients with initial axillary metastasis can achieve axillary complete pathological remission(A-pCR) after neoadjuvant therapy(NAT),These patients are candidates for axillary Surgery de-escalation. This prospective study is designed to evaluate the feasibility and safety of axillary surgery de-escalation for the initial axillary metastasis breast cancer patients who are predicted to achieve A-pCR using multiple pathological indicators and imaging examinations (molecular typing, ultrasound and dedicated breast positron emission tomography, etc.) before and after 1-2 cycles NAT

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Node Recurrence Rate

时间窗: 2 years

a recurrence in the ipsilateral axillary, supraclavicular, or internalmammary nodal basins.

次要结局

未报告次要终点

研究者

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

Zhimin Shao

Professor

Fudan University

研究点 (1)

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