Breast CancerISISNCT06756802
Reproductive Health in Breast Cancer Survivor
An observational study of Breast Cancer, run by Institut Cancerologie de l'Ouest at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- How many people
- 22,000 participants
- Where
- 4 sitesFrance
- Study dates
- 1 Dec 2025to 11 Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women with Breast cancer / Women not diagnosed with breast cancer
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Centre Oscar Lambret
Lille, 59000
Centre Leon Berard
Lyon, 69000
Institut Curie
Paris, 75000
Institut de Cancerologie de L'Ouest
Saint-Herblain, 44805
About this study
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.
Read the 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
- Keywords
- breast cancer, health reproductive, fertility
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Pregnancy rates, as well as all the criteria mentioned in the primary endpoint, will be compared between patients with stage 1 to 3 breast cancer aged 18 to 40 at the time of diagnosis and women without breast cancer from the SNDS. Subpopulations according to treatment will concern only the exposed population.
Measured: 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.
Number of oncofertility consultations and number of fertility preservation acts for each preservation technique, for women with stage 1 to 3 breast cancer, aged 18 to 40 at diagnosis.
Measured: 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.
Relapse-free survival for women with stage 1 to 3 breast cancer, aged 18 to 40 at diagnosis according to the use of MAP method.
Measured: 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.
The risk of breast cancer recurrence will be assessed by recurrence-free survival according to the duration between stopping and restarting tamoxifen, for patients aged 18 to 40 at the time of breast cancer diagnosis.
Measured: 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.
Fetal malformations and perinatal pathologies of the children born will be evaluated by the rates of FCS, fetal malformations, IMG, fetal deaths in utero, neonatal deaths according to the duration of tamoxifen discontinuation (between 3 and 9 months vs. > 9 months), for patients aged 18 to 40 years at the time of breast cancer diagnosis.
Measured: 4 years
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.
Fetal malformations and perinatal pathologies of the children born will be evaluated by the rates of FCS, fetal malformations, IMG, fetal deaths in utero, neonatal deaths, for patients who received tamoxifen and stopped between 3 and 9 months before pregnancy, and for patients who did not receive tamoxifen, among patients aged 18 to 40 years at the time of breast cancer diagnosis.
Measured: 4 years
g) To describe the care pathway for patients aged between 18 and 50 at the time of diagnosis of breast cancer
Time between the diagnostic and, on one hand, first medical gesture, and the other hand, oncogenetic consultation, for women with stage 1 to 3 breast cancer, aged 18 to 50 at diagnosis
Measured: 4 years
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.
Number of women using a contraceptive method and number of unwanted prenancies, for women with stage 1 to 3 breast cancer, aged 18 to 40 at diagnosis, during and after treatment.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start1 Dec 2025
- Primary completion11 Jul 2029 (estimated)
- Study completion11 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 22,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Collaborators
- UNICANCER
- Responsible party
- Sponsor
- Investigators
- Aliette DEZELLUS, MD, Principal investigator, INSTITUT DE CANCEROLOGIE DE L'OUESTMarie ROBERT, MD, Principal investigator, INSTITUT DE CANCERORLOGIE DE L'OUEST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756802
- Sponsor's protocol ID
- ICO-2021-41
- Acronym
- ISIS
- Status last verified
- Feb 2026
- First submitted
- 4 Dec 2024
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The base will be added to the HDH catalogue
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproductive Health in Breast Cancer Survivor
- ClinicalTrials.gov ID
- NCT06756802
- Acronym / sponsor ID
- ISIS / ICO-2021-41
- Conditions
- Breast Cancer
- Keywords
- breast cancer, health reproductive, fertility
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 22,000 participants (estimated)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Collaborators
- UNICANCER
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 11 Jul 2029 (estimated)
- Study completion
- 11 Jul 2029 (estimated)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women with Breast cancer / Women not diagnosed with breast cancer
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- Diagnosis of metastatic breast cancer (stage 4)
- Patients opposed to the use of their data for research purposes
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 4 years
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.
8 secondary outcomes
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 4 years
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.
Time frame: 4 years
g) To describe the care pathway for patients aged between 18 and 50 at the time of diagnosis of breast cancer
Time frame: 4 years
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.
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Yes. The base will be added to the HDH catalogue
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aliette DEZELLUS, MD principal investigator
INSTITUT DE CANCEROLOGIE DE L'OUEST
Marie ROBERT, MD principal investigator
INSTITUT DE CANCERORLOGIE DE L'OUEST
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Institut Cancerologie de l'Ouest at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.