Clinical and Biological Study of Early-onset Breast Cancer and the Influence of the Reproductive Cycle on the Aggressiveness of the Disease (ARTEMIS)
20. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Antatt)
1000
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Marie ROBERT, MD
- Telefonnummer: +33240679900
- E-post: marie.robert@ico.unicancer.fr
Studer Kontakt Backup
- Navn: Vincent GUEN, Ph D
- Telefonnummer: + 33 2 28 08 02 89
- E-post: Vincent.Guen@univ-nantes.fr
Studiesteder
-
-
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Saint-Herblain, Frankrike, 44800
- Institut de Cancérologie de l'Ouest
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Ta kontakt med:
- Laetitia HIMPE
- Telefonnummer: +33240679747
- E-post: laetitia.himpe@ico.unicancer.fr
-
Hovedetterforsker:
- Marie ROBERT, MD
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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Patient aged ≤ 45 years at diagnosis Triple-negative breast cancer
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Ingen inngrep
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Patient aged ≤ 45 years at diagnosis RH+ breast cancer
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Ingen inngrep
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Patient aged ≥ 55 years at diagnosis Triple-negative breast cancer
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Ingen inngrep
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Patient aged ≥ 55 years at diagnosis RH+ breast cancer
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Ingen inngrep
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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event-free survival
Tidsramme: up to 5 years
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event-free survival (time between diagnosis and the occurrence of the first event among the following: local recurrence, metastatic recurrence, death)
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up to 5 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Describe the association between age at diagnosis and event-free survival (EFS) and overall survival.
Tidsramme: up to 5 years
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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)
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up to 5 years
|
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Describe the association between previous pregnancy and overall survival according to age at diagnosis (≤45 years or ≥55 years).
Tidsramme: Up to 5 years
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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
|
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Describe the association between breastfeeding and EFS/overall survival in nulliparous women according to age at diagnosis (≤45 years or ≥55 years).
Tidsramme: Up to 5 years
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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
|
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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).
Tidsramme: 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
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Marie ROBERT, MD, Institut de Cancérologie de l'Ouest
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. mai 2026
Primær fullføring (Antatt)
1. september 2026
Studiet fullført (Antatt)
1. februar 2031
Datoer for studieregistrering
Først innsendt
12. februar 2026
Først innsendt som oppfylte QC-kriteriene
20. mai 2026
Først lagt ut (Faktiske)
22. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. mai 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ICO-2024-25
- 2025-A02135-4 (Annen identifikator: INSTITUT DE CANCEROLOGIE DE L'OUEST)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
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-delingstidsramme
The data will be accessible from 6 months after the publication of the main article, and for up to 3 years after this publication.
Tilgangskriterier for IPD-deling
Access will be granted to researchers submitting a methodologically sound proposal that does not duplicate the secondary analyses planned by the research team.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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