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Reproductive Health in Breast Cancer Survivor

NCT06756802 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 22000

Last updated 2026-02-17

No results posted yet for this study

Summary

With the age of first pregnancy increasing (average age of mother at childbirth: 31.0 in 2022), and the incidence of breast cancer increasing in young women (+2.1% per year according to some registries, more and more women will develop breast cancer before they have a child. FP must be offered to all women under 40 who are going to receive potentially gonadotoxic treatment (French bioethics law of 06/08/04, revised on 07/07/2011). It therefore seems appropriate to collect data from patients aged between 18 and 40 at diagnosis (previous fertility, fertility preservation before chemotherapy). Furthermore, the theoretical risk of pregnancy persists until the menopause. For the study of contraception, patients aged up to 50 at diagnosis will therefore be included. In view of the EMA's recent warning on the genotoxic risk of tamoxifen, the investigator feel that it would be relevant to collect data on the health status of newborns born after breast cancer (three compulsory medical examinations in the first month of life to detect any malformative pathologies).

A better understanding of these issues would enable national and even international recommendations to be updated, patients to be better informed and the long-term consequences on fertility to be better managed.

Conditions

Sponsors & Collaborators

  • UNICANCER

    collaborator OTHER

  • Institut Cancerologie de l'Ouest

    lead OTHER

Principal Investigators

  • Aliette DEZELLUS, MD · INSTITUT DE CANCEROLOGIE DE L'OUEST

  • Marie ROBERT, MD · INSTITUT DE CANCERORLOGIE DE L'OUEST

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2029-07-11
Completion
2029-07-11

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06756802 on ClinicalTrials.gov