Clinical trial NCT06756802: Reproductive Health in Breast Cancer Survivor
Official title: Reproductive Health in Breast Cancer Survivor
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Keywords: breast cancer
health reproductive
fertility
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
Collaborators: name: UNICANCER
First posted: 2025-01-03
Enrollment: 22000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with Breast cancer / Women not diagnosed with breast cancer

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.

Eligibility criteria: Exposed cohort (Breast cancer patient)

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.

Primary outcomes:
measure: 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.
timeFrame: 4 years
Secondary outcomes:
measure: 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
timeFrame: 4 years
measure: 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.
timeFrame: 4 years
measure: 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.
timeFrame: 4 years
measure: 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.
timeFrame: 4 years
measure: 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.
timeFrame: 4 years
measure: f) To describe fetal malformations and perinatal pathologies in children born after tamoxifen was stopped 3 to 9 months before the start of pregnancy and after no tamoxifen was taken, in patients aged 18 to 40 at the time of diagnosis of breast cancer.
timeFrame: 4 years
measure: g) To describe the care pathway for patients aged between 18 and 50 at the time of diagnosis of breast cancer
timeFrame: 4 years
measure: h) To describe contraception and the rate of abortion during and after treatment for breast cancer in patients aged between 18 and 50 at the time of their diagnosis.
timeFrame: 4 years
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Leon Berard
city: Paris
country: France
facility: Institut Curie
city: Saint Herblain
country: France
facility: Institut de Cancerologie de L'Ouest
Study officials:
affiliation: INSTITUT DE CANCEROLOGIE DE L'OUEST
name: Aliette DEZELLUS, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: INSTITUT DE CANCERORLOGIE DE L'OUEST
name: Marie ROBERT, MD
role: PRINCIPAL_INVESTIGATOR
References: