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临床试验/NCT06877416
NCT06877416招募中不适用

A Multi-center, Retrospective, Study on Exploring Optimized Sequential Treatment Strategies of Antibody-Drug Conjugates (ADCs) in HER2-Low-Expressing Breast Cancer

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2020年1月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
700
试验地点
1
主要终点
Progression-free survival

研究概览

简要总结

This study retrospectively analyzes the clinical data of HER2-low breast cancer (IHC 1+/2+ and FISH-negative) patients treated with sequential antibody-drug conjugates (ADCs). Key variables include patient demographics, tumor characteristics, ADC regimens (e.g., trastuzumab deruxtecan, sacituzumab govitecan), treatment sequencing, survival outcomes, and safety profiles. Genomic data (e.g., HER2 expression dynamics, TROP2 levels) are integrated to explore resistance mechanisms and prognostic biomarkers.mechanisms.

This study aims to investigate the efficacy of different ADC sequential regimens in HER2-low breast cancer patients.

详细描述

Breast cancer is one of the most common malignancies in women, posing a significant threat to female health. According to current molecular subtypes, breast cancer is classified into hormone receptor-positive, HER2-positive, and triple-negative breast cancer. However, with the development of novel therapeutic strategies such as antibody-drug conjugates (ADCs), increasing attention has been directed toward HER2-low breast cancer (defined as HER2 immunohistochemistry [IHC] 1+ or 2+/FISH-negative), which accounts for approximately 60%-70% of breast cancer cases. ADCs can exert potential therapeutic effects in HER2-low breast cancer through the "bystander effect" and have been widely adopted in clinical practice. Nevertheless, the optimal sequential treatment strategy for HER2-low patients remains unclear, with a lack of definitive clinical guidelines and limited understanding of resistance mechanisms.

This study aims to investigate the efficacy of different ADC sequential regimens in HER2-low breast cancer patients and explore potential resistance mechanisms. By conducting a retrospective analysis of clinical data from HER2-low patients treated with sequential ADCs, the investigators will evaluate the therapeutic outcomes and safety profiles of various ADC sequencing approaches. Additionally, integrating genomic profiling with routine clinical data, the investigators seek to identify prognostic biomarkers and elucidate resistance pathways. The findings are expected to guide personalized treatment strategies for HER2-low breast cancer patients, ultimately improving clinical outcomes.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Diagnosed with HER2-low breast cancer, defined as immunohistochemistry (IHC) score of 1+ or IHC score of 2+ with negative in situ hybridization (FISH-negative)
  • Received sequential administration of two or more ADCs
  • Complete data for patient's character, laboratory and imaging test, treatment and follow-up are available.

排除标准

  • Concomitant with other tumor components at the time of diagnosis;
  • Have a history of any other malignant tumors;
  • Lack of complete data

结局指标

主要结局

Progression-free survival

时间窗: From date of diagnosis until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.

The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.

次要结局

  • Overall survival(From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 24 months.)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yalan Yang

Clinical Investigator

Sun Yat-sen University

研究点 (1)

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