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

ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeUp to 45
SponsorInstitut Cancerologie de l'Ouest

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Availability of a diagnostic tumor sample

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • No Intervention: Observational Cohort

    Other intervention

    No intervention

Treatment groups

1,000 Participants
are divided into 4 treatment groups
Group A: Patient aged ≤ 45 years at diagnosis Triple-negative breast cancer1 intervention
Group B: Patient aged ≤ 45 years at diagnosis RH+ breast cancer1 intervention
Group C: Patient aged ≥ 55 years at diagnosis Triple-negative breast cancer1 intervention
Group D: Patient aged ≥ 55 years at diagnosis RH+ breast cancer1 intervention

Trial outcomes

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)

Time frame
up to 5 years

Secondary outcomes

1

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)

Time frame
up to 5 years
2

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)

Time frame
Up to 5 years
3

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)

Time frame
Up to 5 years
4

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)

Time frame
Up to 5 years

Other outcomes

Sponsors and contacts

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