Clinical trial · Observational
Reproductive Health in Breast Cancer Survivor
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Exposed cohort
- description
- Patients in ConSoRe data with a diagnosis of stage 1 to 3 breast cancer between 01/01/2010 and 31/12/2018.
- label
- Non-exposed cohort
- description
- Women present in the SNDS data, without a diagnosis of breast cancer, born between 01/01/1970 and 31/12/2000.
- label
- Cohort associated with the exposed cohort
- description
- Children of included patients born after diagnosis of breast cancer.
Primary outcomes (1)
- 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
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available