Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07601152

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Breast Cancer Behavior Breast Diseases Breast Feeding Breast Neoplasms Feeding Behavior Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

Up to 45 year

Sex eligibility

Female

Study type

Observational

Primary location

Institut de Cancerologie de L'Ouest

Saint-Herblain, 44800, France

Location contact

Laetitia HIMPE

CONTACT

[email protected]

+33240679747

Marie ROBERT, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No Intervention: Observational Cohort

Other

No intervention

Primary outcomes

  1. event-free survival

    Time frame: 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)

Secondary outcomes

  1. Describe the association between age at diagnosis and event-free survival (EFS) and overall survival.

    Time frame: 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)

  2. Describe the association between previous pregnancy and overall survival according to age at diagnosis (≤45 years or ≥55 years).

    Time frame: 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)

  3. Describe the association between breastfeeding and EFS/overall survival in nulliparous women according to age at diagnosis (≤45 years or ≥55 years).

    Time frame: 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)

  4. 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).

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Marie ROBERT, MD

CONTACT

[email protected]

+33240679900

Vincent GUEN, Ph D

CONTACT

[email protected]

+ 33 2 28 08 02 89

Sponsors and collaborators

Lead sponsor

Institut Cancerologie de l'Ouest

Other

Registry information

Acronym: ARTEMIS

Important dates

Study start
2026
Primary completion
2026
Study completion
2031
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.