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

NCT07601152 — Not yet recruiting, 1000 participants, Institut Cancerologie de l'Ouest

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT07601152, acronym ARTEMIS
Status	Not yet recruiting
Study type	Observational
Enrollment	1000 (Estimated)
Sponsor	Institut Cancerologie de l'Ouest (Other)
Conditions	Breast Cancer
Interventions	No Intervention: Observational Cohort (Other)
Dates	start 2026-05-01 (estimated), primary completion 2026-09-01 (estimated), completion 2031-02-01 (estimated), first posted 2026-05-22, last updated 2026-05-22
Locations	1 site in France

-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. 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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
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

No Intervention: Observational Cohort (Other): No intervention

+Outcome measures

Primary outcomes

event-free survival [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

Describe the association between age at diagnosis and event-free survival (EFS) and overall survival. [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)
Describe the association between previous pregnancy and overall survival according to age at diagnosis (≤45 years or ≥55 years). [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)
Describe the association between breastfeeding and EFS/overall survival in nulliparous women according to age at diagnosis (≤45 years or ≥55 years). [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)
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). [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)

+Eligibility

Sex: Female, ages: any to 45 Years

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

+Locations (1)

Facility	City	Country	Status
Institut de Cancerologie de L'Ouest	Saint-Herblain	France

+Investigators

Marie ROBERT, MD, Principal investigator, INSTITUT DE CANCEROLOGIE DE L'OUEST