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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut Cancerologie de l'Ouest

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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