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

May 20, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Saint-Herblain, France, 44800
        • Institut de Cancérologie de l'Ouest
        • Contact:
        • Principal Investigator:
          • Marie ROBERT, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient aged ≤ 45 years at diagnosis Triple-negative breast cancer
Other: No Intervention: Observational Cohort
No intervention
Patient aged ≤ 45 years at diagnosis RH+ breast cancer
Other: No Intervention: Observational Cohort
No intervention
Patient aged ≥ 55 years at diagnosis Triple-negative breast cancer
Other: No Intervention: Observational Cohort
No intervention
Patient aged ≥ 55 years at diagnosis RH+ breast cancer
Other: No Intervention: Observational Cohort
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
up to 5 years
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)
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).
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)
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).
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)
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Cancerologie de l'Ouest

Investigators

  • Principal Investigator: Marie ROBERT, MD, Institut de Cancérologie de l'Ouest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

February 1, 2031

Study Registration Dates

First Submitted

February 12, 2026

First Submitted That Met QC Criteria

May 20, 2026

First Posted (Actual)

May 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICO-2024-25
  • 2025-A02135-4 (Other Identifier: INSTITUT DE CANCEROLOGIE DE L'OUEST)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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 Sharing Time Frame

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 Sharing Access Criteria

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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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