Breast CancerARTEMISNCT07601152
Clinical and Biological Study of Early-onset Breast Cancer and the Influence of the Reproductive Cycle on the Aggressiveness of the Disease
An observational study of Breast Cancer, run by Institut Cancerologie de l'Ouest at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 45 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- May 2026to Feb 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 45 years
- Women only
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- Availability of a diagnostic tumor sample
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Institut de Cancerologie de L'Ouest
Saint-Herblain, 44800
Laetitia HIMPE, +33240679747, laetitia.himpe@ico.unicancer.fr
Marie ROBERT, MD
About this study
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.
- Conditions
- Breast Cancer
- Being tested
- No Intervention: Observational Cohort
- Keywords
- Early breast cancer, breastfeeding, pregnancy, reproductive cycle
- Medical subject headings
- Breast Neoplasms, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Patient aged ≤ 45 years at diagnosis Triple-negative breast cancer | Not described Receives: Other: No Intervention: Observational Cohort | |
| Patient aged ≤ 45 years at diagnosis RH+ breast cancer | Not described Receives: Other: No Intervention: Observational Cohort | |
| Patient aged ≥ 55 years at diagnosis Triple-negative breast cancer | Not described Receives: Other: No Intervention: Observational Cohort | |
| Patient aged ≥ 55 years at diagnosis RH+ breast cancer | Not described Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
event-free survival
event-free survival (time between diagnosis and the occurrence of the first event among the following: local recurrence, metastatic recurrence, death)
Measured: up to 5 years
Secondary outcomes (4)
Describe the association between age at diagnosis and event-free survival (EFS) and overall survival.
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)
Measured: up to 5 years
Describe the association between previous pregnancy and overall survival according to age at diagnosis (≤45 years or ≥55 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)
Measured: 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).
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)
Measured: 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).
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)
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study startMay 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie ROBERT, MD, Principal investigator, INSTITUT DE CANCEROLOGIE DE L'OUEST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601152
- Sponsor's protocol ID
- ICO-2024-25
- Other IDs
- 2025-A02135-4
- Acronym
- ARTEMIS
- Status last verified
- Apr 2026
- First submitted
- 12 Feb 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Biological Study of Early-onset Breast Cancer and the Influence of the Reproductive Cycle on the Aggressiveness of the Disease
- ClinicalTrials.gov ID
- NCT07601152
- Acronym / sponsor ID
- ARTEMIS / ICO-2024-25
- Conditions
- Breast Cancer
- Keywords
- Early breast cancer, breastfeeding, pregnancy, reproductive cycle
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patient aged ≤ 45 years at diagnosis Triple-negative breast cancer | – | Other: No Intervention: Observational Cohort |
| Patient aged ≤ 45 years at diagnosis RH+ breast cancer | – | Other: No Intervention: Observational Cohort |
| Patient aged ≥ 55 years at diagnosis Triple-negative breast cancer | – | Other: No Intervention: Observational Cohort |
| Patient aged ≥ 55 years at diagnosis RH+ breast cancer | – | Other: No Intervention: Observational Cohort |
Who may qualify
- Ages
- Up to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Availability of a diagnostic tumor sample
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortNo intervention | Other | Patient aged ≤ 45 years at diagnosis RH+ breast cancer, Patient aged ≤ 45 years at diagnosis Triple-negative breast cancer, Patient aged ≥ 55 years at diagnosis RH+ breast cancer, Patient aged ≥ 55 years at diagnosis Triple-negative breast cancer |
Primary outcome
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)
4 secondary outcomes
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 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 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 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie ROBERT, MD principal investigator
INSTITUT DE CANCEROLOGIE DE L'OUEST
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Institut Cancerologie de l'Ouest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie ROBERT, MD (+33240679900, marie.robert@ico.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
event-free survival (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.