ClinicalTrials.gg
Not yet recruitingNCT07601152ARTEMISUpdated May 22, 2026

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

An observational study in Breast Cancer, sponsored by Institut Cancerologie de l'Ouest. Not yet recruiting at 1 site in France. Open to female participants aged Up to 45 Years. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by Institut Cancerologie de l'Ouest · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,000
Ages
Up to 45 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 35 studies in Breast Neoplasms by Institut Cancerologie de l'Ouest — 7 open to participants now, 12 under way, none of them phase 3. Breast Neoplasms · Institut Cancerologie de l'Ouest.

Planned enrollment
2nd of 12
1,000 · median 195
Started
2026
with 2 others
Observational
12 of 35
2 open now
Primary completion
2026-09
later than 4 of 11 live
Registered
33rd of 35
by date

Among the 35 studies in Breast Neoplasms by Institut Cancerologie de l'Ouest, this one is the 2nd largest by planned enrollment of the 12 observational ones that give a count, is one of 3 that started in 2026, is one of 12 observational ones, reaches primary completion later than 4 of the 11 other live ones, and was the 33rd registered.

Breast Neoplasms

14,829 studies on the registry are indexed under Breast Neoplasms; 3,318 are open to participants now.

Browse Breast Neoplasms studies →

Open to participants now

7 of the 35 studies in Breast Neoplasms by Institut Cancerologie de l'Ouest are open now, in 1 country. Recruiting first, the newest first:

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By country, each count listing its studies:

All 7 open studies →

Where they have run

Who these studies take

Of the 2,398 Breast Neoplasms studies recruiting now, 1,569 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.

This study: Up to 45 Years · female · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Breast Cancer

Keywords

  • Early breast cancer
  • breastfeeding
  • pregnancy
  • reproductive cycle
04

Who can participate

Ages eligible
Up to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Triple-negative breast cancer or RH+/-
  • Patient aged ≤ 45 years at the time of diagnosis ou Patient aged ≥ 55 years at the time of diagnosis

Exclusion criteria

Exclusion Criteria:

  • Availability of a diagnostic tumor sample
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HER2

HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.

In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • OtherNo Intervention: Observational Cohort

    No intervention

06

What researchers measure

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

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes — 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).

Supporting information: 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for May 2026; primary completion for Sep 2026, 4 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 12, 2026
First posted
May 22, 2026
StartEst.
May 2026
Primary completionEst.
Sep 2026
CompletionEst.
Feb 2031
Last update
May 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07601152
Responsible party
Sponsor
First posted
May 22, 2026
Start date
May 2026 (estimated)
Primary completion
Sep 2026 (estimated)
Completion
Feb 2031 (estimated)
Last update
May 22, 2026

Study contacts

Marie ROBERT, MD
Contact
marie.robert@ico.unicancer.fr
+33240679900
Vincent GUEN, Ph D
Contact
Vincent.Guen@univ-nantes.fr
+ 33 2 28 08 02 89
Marie ROBERT, MD
principal investigator · INSTITUT DE CANCEROLOGIE DE L'OUEST

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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