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Clinical and Biological Study of Early-onset Breast Cancer and the Influence of the Reproductive Cycle on the Aggressiveness of the Disease (ARTEMIS)

2026年5月20日 更新者：Institut Cancerologie de l'Ouest

The incidence of breast cancer is increasing, particularly among young women. Cancers in young women are associated with a poor prognosis. The causes remain poorly understood.

Among young patients, some are nulliparous and others have reported cancer during or after pregnancy. Preliminary studies suggest that breast tissue remodeling associated with pregnancy may influence the emergence and aggressiveness of early-onset cancers. However, breastfeeding and pregnancy are described as protective factors against the onset of breast cancer. The precise biology depending on age and the time between pregnancy and breast cancer is still poorly understood.

The aim of our study is to increase our knowledge of cancer in young women and its potential links to pregnancy and breastfeeding. Information on the contraceptive habits and pregnancies of the patients in the study will be collected, and molecular and cellular analyses will be performed on frozen tumor samples as well as samples fixed and embedded in paraffin.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

观察性的

注册 (估计的)

1000

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 法国
      • Saint-Herblain、法国、44800
        • Institut de Cancérologie de l'Ouest
        • 接触：
        • 首席研究员：
          • Marie ROBERT, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人

接受健康志愿者

不

取样方法

非概率样本

研究人群

Patients with triple-negative (TN) or RH+ breast cancer treated at the ICO who were ≤ 45 years old or ≥ 55 years old at the time of diagnosis.

描述

Inclusion Criteria:

  • Triple-negative breast cancer or RH+/HER2-
  • Patient aged ≤ 45 years at the time of diagnosis ou Patient aged ≥ 55 years at the time of diagnosis

Exclusion Criteria:

  • Availability of a diagnostic tumor sample

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
Patient aged ≤ 45 years at diagnosis Triple-negative breast cancer
其他：无干预：观察队列
不干预
Patient aged ≤ 45 years at diagnosis RH+ breast cancer
其他：无干预：观察队列
不干预
Patient aged ≥ 55 years at diagnosis Triple-negative breast cancer
其他：无干预：观察队列
不干预
Patient aged ≥ 55 years at diagnosis RH+ breast cancer
其他：无干预：观察队列
不干预

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
event-free survival
大体时间：up to 5 years
event-free survival (time between diagnosis and the occurrence of the first event among the following: local recurrence, metastatic recurrence, death)
up to 5 years

次要结果测量

结果测量
措施说明
大体时间
Describe the association between age at diagnosis and event-free survival (EFS) and overall survival.
大体时间：up to 5 years
Describe the association between age at diagnosis and event-free survival (EFS) and overall survival (time between diagnosis and death from all causes. Two overall survival rates will be calculated from two data sources: ICO data and INSEE data)
up to 5 years
Describe the association between previous pregnancy and overall survival according to age at diagnosis (≤45 years or ≥55 years).
大体时间：Up to 5 years
Describe the association between previous pregnancy and overall survival according to age at diagnosis (≤45 years or ≥55 years). (Overall survival: time between diagnosis and death from all causes. Two overall survival rates will be calculated from two data sources: ICO data and INSEE data)
Up to 5 years
Describe the association between breastfeeding and EFS/overall survival in nulliparous women according to age at diagnosis (≤45 years or ≥55 years).
大体时间：Up to 5 years
Describe the association between breastfeeding and EFS/overall survival in nulliparous women according to age at diagnosis (≤45 years or ≥55 years).(Overall survival: time between diagnosis and death from all causes. Two overall survival rates will be calculated from two data sources: ICO data and INSEE data)
Up to 5 years
Describe the association between age at first pregnancy (≥35 years, ≤35 years, nulliparity) and EFS/overall survival according to age at diagnosis (≤45 years or ≥55 years).
大体时间：Up to 5 years
Describe the association between age at first pregnancy (≥35 years, ≤35 years, nulliparity) and EFS/overall survival according to age at diagnosis (≤45 years or ≥55 years).(Overall survival: time between diagnosis and death from all causes. Two overall survival rates will be calculated from two data sources: ICO data and INSEE data)
Up to 5 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Institut Cancerologie de l'Ouest

调查人员

  • 首席研究员：Marie ROBERT, MD、Institut de Cancérologie de l'Ouest

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年5月1日

初级完成 (估计的)

2026年9月1日

研究完成 (估计的)

2031年2月1日

研究注册日期

首次提交

2026年2月12日

首先提交符合 QC 标准的

2026年5月20日

首次发布 (实际的)

2026年5月22日

研究记录更新

最后更新发布 (实际的)

2026年5月22日

上次提交的符合 QC 标准的更新

2026年5月20日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • ICO-2024-25
  • 2025-A02135-4 (其他标识符：INSTITUT DE CANCEROLOGIE DE L'OUEST)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

The anonymized individual participant data used in the primary analysis of the study will be made available. This includes the main manuscript and its supplementary materials (texts, tables, figures, and appendices).

IPD 共享时间框架

The data will be accessible from 6 months after the publication of the main article, and for up to 3 years after this publication.

IPD 共享访问标准

Access will be granted to researchers submitting a methodologically sound proposal that does not duplicate the secondary analyses planned by the research team.

IPD 共享支持信息类型

  • 研究方案

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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