Reproductive Health in Breast Cancer Survivor

NCT ID: NCT06756802

Last Updated: 2025-01-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 22000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-11
• Study Completion Date: 2029-07-11

Brief 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.

Detailed Description

The impact of cancer treatments on reproductive life and the health of unborn children is a major concern for young patients diagnosed and treated for cancer.

The information gathered by this project will make it possible to provide clearer and more accurate information to patients about the consequences of cancer therapies on their reproductive lives. In addition, the investigator hope to be able to reassure doctors about the use of fertility preservation before breast cancer and MPA after breast cancer, and to have arguments for fertility preservation and MPA to be offered more systematically to patients.

Answering such questions in prospective trials would require a long follow-up period and the inclusion of a very large number of patients. The creation of a multicentre retrospective database could provide answers to a large number of questions about the impact of anti-cancer therapies on reproductive life in the management of female breast cancer. In addition, to limit the risk of bias, these data will be compared with those of a population of women of the same age without breast cancer.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Exposed cohort

Patients in ConSoRe data with a diagnosis of stage 1 to 3 breast cancer between 01/01/2010 and 31/12/2018.

No interventions assigned to this group

Non-exposed cohort

Women present in the SNDS data, without a diagnosis of breast cancer, born between 01/01/1970 and 31/12/2000.

No interventions assigned to this group

Cohort associated with the exposed cohort

Children of included patients born after diagnosis of breast cancer.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients aged between 18 and 50 at the time of diagnosis of breast cancer
• Diagnosed with stage 1 to 3 breast cancer between 01/01/2010 and 31/12/2018
• Patients treated in one of the identified ConSoRe partner centres (CLB, ICO, COL, IC)

Exclusion Criteria

• Diagnosis of metastatic breast cancer (stage 4)
• Patients opposed to the use of their data for research purposes

Unexposed cohort (data from the SNDS) :

Population derived from the SNDS, among women not diagnosed with breast cancer, of the same ages (same year of birth) and the same geographical area (same département of residence) as the exposed population.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

UNICANCER

OTHER

Sponsor Role: collaborator

Institut Cancerologie de l'Ouest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aliette DEZELLUS, MD

Role: PRINCIPAL_INVESTIGATOR

INSTITUT DE CANCEROLOGIE DE L'OUEST

Marie ROBERT, MD

Role: PRINCIPAL_INVESTIGATOR

INSTITUT DE CANCERORLOGIE DE L'OUEST

Locations

Centre Oscar Lambret

Lille, , France

Centre Leon Berard

Lyon, , France

Institut Curie

Paris, , France

Institut de Cancerologie de L'Ouest

Saint-Herblain, , France

Countries

France

Other Identifiers

ICO-2021-41

Identifier Type: -

Identifier Source: org_study_id