Reproductive Health in Breast Cancer Survivor

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.

NCT Number	NCT06756802
Lead Sponsor	Institut Cancerologie de l'Ouest Collaborators: UNICANCER
Conditions	Breast Cancer
Enrollment	22,000 participants
Start Date	2025-12-01
Primary Completion	2029-07-11 (estimated)
Study Completion	2029-07-11 (estimated)
Updated on ClinicalTrials.gov	2026-02-17