Reproductive Health in Breast Cancer Survivor

NCT06756802 | Active Not Recruiting DMC

• 1 other identifier: ICO-2021-41
• Study Type: observational
• Target: 22,000
• Locations: 1 country
• Sites: 4

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.

Conditions

Breast Cancer

Keywords

breast cancer; health reproductive; fertility

Outcome Measures

Primary Outcomes (1)

• to describe pregnancies (number, origin and outcome) after stage 1 to 3 breast cancer in women aged 18 to 40 at diagnosis, according to age at diagnosis and treatment received.

  Number of spontaneous and MPA pregnancies, with viable child or not, after stage 1 to 3 breast cancer in women aged 18 to 40 at diagnosis, according to age at diagnosis and treatments received.

  4 years

Secondary Outcomes (8)

• a) Compare the pregnancy rate after breast cancer, for patients aged 18 to 40 at the time of diagnosis of breast cancer, with the pregnancy rate in a sample of women without breast cancer from the general population, overall and, for patients, by sub-gro

  4 years

• b) To describe the use of fertility preservation before chemotherapy: oncofertility consultation, preservation techniques for patients aged between 18 and 40 at the time of diagnosis of breast cancer.

  4 years

• c) Describe the link between recourse to MAP after cancer and the risk of recurrence, for patients aged between 18 and 40 at the time of diagnosis of breast cancer.

  4 years

• d) To describe the risk of breast cancer recurrence according to the time between stopping and restarting tamoxifen, for patients aged 18 to 40 at the time of diagnosis of breast cancer.

  4 years

• e) To describe fetal malformations and perinatal pathologies in children born according to the duration of tamoxifen discontinuation (3 to 9 months vs. > 9 months), for patients aged 18 to 40 years at the time of breast cancer diagnosis.

  4 years

Study Arms (3)

Exposed cohort

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

Non-exposed cohort

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

Cohort associated with the exposed cohort

Children of included patients born after diagnosis of breast cancer.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women with Breast cancer / Women not diagnosed with breast cancer

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNICANCER: collaborator
• Institut Cancerologie de l'Ouest: lead

Study Sites (4)

Centre Oscar Lambret

Lille, 59000, France

Location

Centre Leon Berard

Lyon, 69000, France

Location

Institut Curie

Paris, 75000, France

Location

Institut de Cancerologie de L'Ouest

Saint-Herblain, 44805, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Aliette DEZELLUS, MD

  INSTITUT DE CANCEROLOGIE DE L'OUEST

  PRINCIPAL INVESTIGATOR

• Marie ROBERT, MD

  INSTITUT DE CANCERORLOGIE DE L'OUEST

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: January 3, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): July 11, 2029
• Study Completion (Estimated): July 11, 2029
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Unknowed

Locations

FR (4)