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

• 2 other identifiers: ICO-2024-252025-A02135-4
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Early breast cancer; breastfeeding; pregnancy; reproductive cycle

Outcome Measures

Primary Outcomes (1)

• event-free survival

  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 Outcomes (4)

• Describe the association between age at diagnosis and event-free survival (EFS) and overall survival.

  up to 5 years

• 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 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 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

Study Arms (4)

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

Interventions

No Intervention: Observational Cohort OTHER

No intervention

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

Eligibility Criteria

• Age: Up to 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Availability of a diagnostic tumor sample

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (1)

Institut de Cancerologie de L'Ouest

Saint-Herblain, 44800, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Diagnostic frozen tumor samples and FFPE tissue sections

MeSH Terms

Conditions

Breast Neoplasms; Breast Feeding

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Feeding Behavior; Behavior

Study Officials

• Marie ROBERT, MD

  INSTITUT DE CANCEROLOGIE DE L'OUEST

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie ROBERT, MD

CONTACT

+33240679900; marie.robert@ico.unicancer.fr

Vincent GUEN, Ph D

CONTACT

+ 33 2 28 08 02 89; Vincent.Guen@univ-nantes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: May 22, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): February 1, 2031
• Last Updated: May 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• 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.

Locations

FR (1)