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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07601152
Acronym
ARTEMIS
Enrollment
1000
Registered
2026-05-22
Start date
2026-05-01
Completion date
2031-02-01
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Early breast cancer, breastfeeding, pregnancy, reproductive cycle

Brief 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.

Interventions

OTHERNo Intervention: Observational Cohort

No intervention

Sponsors

Institut Cancerologie de l'Ouest
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
No minimum to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
event-free survivalup to 5 yearsevent-free survival (time between diagnosis and the occurrence of the first event among the following: local recurrence, metastatic recurrence, death)

Secondary

MeasureTime frameDescription
Describe the association between age at diagnosis and event-free survival (EFS) and overall survival.up to 5 yearsDescribe 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 yearsDescribe 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 yearsDescribe 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 yearsDescribe 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)

Countries

France

Contacts

CONTACTMarie ROBERT, MD
marie.robert@ico.unicancer.fr+33240679900
CONTACTVincent GUEN, Ph D
Vincent.Guen@univ-nantes.fr+ 33 2 28 08 02 89
PRINCIPAL_INVESTIGATORMarie ROBERT, MD

INSTITUT DE CANCEROLOGIE DE L'OUEST

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026