Breast CancerBeyond BCYNCT07591532
Pregnancy Outcomes After Breast Cancer in Young Women With Germline Pathogenic Variants in Genes Other Than BRCA
An observational study of Breast Cancer and Breast Cancer and Pregnancy, run by Jules Bordet Institute.
Trial summary
The present study aims to refine the understanding of the prognostic impact of pregnancy after breast cancer in young women harboring germline pathogenic variants in breast cancer susceptibility genes other than BRCA Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Breast Cancer, Breast Cancer and Pregnancy
- How many people
- 2,200 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Dec 2030
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Young women diagnosed at age 40 years or younger with stage I-III invasive breast cancer between January 2000 and December 2025 and harboring a germline pathogenic variant in a breast cancer susceptibility gene other than BRCA1/2, including TP53, PALB2, PTEN, CDH1, STK11, CHEK2, ATM, BARD1, RAD51C, and RAD51D.
Who may be able to join
- Diagnosis of stage I-III invasive breast cancer between January 2000 and December 2025
- Age at breast cancer diagnosis ≤40 years
- Germline pathogenic variant in at least one of the following breast cancer susceptibility genes other than BRCA: TP53, PALB2, PTEN, CDH1, STK11, CHEK2, ATM, BARD1, RAD51C, or RAD51D
Who cannot join
- Known germline pathogenic variant in breast cancer susceptibility genes without a diagnosis of invasive breast cancer
- Diagnosis of ovarian cancer or other malignancies without a prior history of invasive breast cancer
- Diagnosis of invasive breast cancer with germline variants of uncertain significance in breast cancer susceptibility genes
- De novo stage IV breast cancer
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Luca Arecco, MD contact
About this study
Official title: Retrospective Observational Study on the Prognostic Impact of Pregnancy in Young Women With Breast Cancer Harboring a Germline Pathogenic Variant in Breast Cancer-related Genes Other Than BRCA1/2: the "Beyond BRCA BCY Collaboration"
The present study aims to refine the understanding of the prognostic impact of pregnancy after breast cancer in young women harboring germline pathogenic variants in breast cancer susceptibility genes other than BRCA
Read the detailed description
This retrospective, multicenter, observational study aims to evaluate the prognostic impact of pregnancy after breast cancer diagnosis in young women harboring germline pathogenic variants in breast cancer susceptibility genes other than BRCA1/2, including TP53, PALB2, PTEN, CDH1, STK11, CHEK2, ATM, BARD1, RAD51C, and RAD51D.
Although pregnancy after breast cancer has been shown to be safe in the overall population of young breast cancer survivors and in carriers of BRCA1/2 pathogenic variants, evidence remains limited for patients with pathogenic variants in other breast cancer susceptibility genes. This knowledge gap represents a relevant unmet need in oncofertility counseling and survivorship care.
The study will include patients diagnosed with stage I-III invasive breast cancer at age 40 years or younger between January 2000 and December 2025. The primary objectives are to assess the prognostic impact of pregnancy after breast cancer diagnosis and to evaluate the cumulative incidence of pregnancy in this population. Secondary objectives include the assessment of pregnancy, fetal, and obstetrical outcomes, the safety of assisted reproductive technology procedures, patterns of care including risk-reducing surgeries, survival outcomes according to clinicopathologic and genetic subgroups, and the occurrence of second primary malignancies.
Data will be collected retrospectively from participating centers within the Beyond BRCA BCY Collaboration.
- Conditions
- Breast Cancer, Breast Cancer and Pregnancy
- Keywords
- breast cancer, Pregnancy, Young Women, Hereditary Breast Cancer, Germline Pathogenic Variants, Breast Cancer Susceptibility Genes, Oncofertility, TP53, PALB2, PTEN, CDH1, STK11, CHEK2, ATM, BARD1, RAD51C, RAD51D
- Medical subject headings
- Breast Neoplasms, Breast Cancer, Familial
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 |
|---|---|---|
| Pregnant cohort | Women with one or more pregnancies any time after breast cancer diagnosis | |
| Non-pregnant cohort | Women with no subsequent pregnancies after breast cancer diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Incidence of Pregnancy After Breast Cancer Diagnosis
Measured: Up to 20 years from breast cancer diagnosis
Invasive Disease-Free Survival (iDFS)
Measured: Up to 20 years from breast cancer diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2030 (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
- 2,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matteo Lambertini, MD, PhD, Principal investigator, IRCCS Azienda Ospedaliera MetropolitanaEvandro de Azambuja, MD, PhD, Principal investigator, Jules Bordet Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591532
- Sponsor's protocol ID
- IJB-BEYOND-BCY-01
- Acronym
- Beyond BCY
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified individual participant data may be shared upon reasonable request, subject to submission of a formal research proposal to the study Principal Investigators and review and approval by the study leadership. Any data sharing will be subject to applicable ethics approvals, data transfer agreements, local institutional requirements, and data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Observational Study on the Prognostic Impact of Pregnancy in Young Women With Breast Cancer Harboring a Germline Pathogenic Variant in Breast Cancer-related Genes Other Than BRCA1/2: the "Beyond BRCA BCY Collaboration"
- ClinicalTrials.gov ID
- NCT07591532
- Acronym / sponsor ID
- Beyond BCY / IJB-BEYOND-BCY-01
- Conditions
- Breast Cancer, Breast Cancer and Pregnancy
- Keywords
- breast cancer, Pregnancy, Young Women, Hereditary Breast Cancer, Germline Pathogenic Variants, Breast Cancer Susceptibility Genes, Oncofertility, TP53
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 15 May 2026 (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.
The present study aims to refine the understanding of the prognostic impact of pregnancy after breast cancer in young women harboring germline pathogenic variants in breast cancer susceptibility genes other than BRCA
Detailed description
This retrospective, multicenter, observational study aims to evaluate the prognostic impact of pregnancy after breast cancer diagnosis in young women harboring germline pathogenic variants in breast cancer susceptibility genes other than BRCA1/2, including TP53, PALB2, PTEN, CDH1, STK11, CHEK2, ATM, BARD1, RAD51C, and RAD51D.
Although pregnancy after breast cancer has been shown to be safe in the overall population of young breast cancer survivors and in carriers of BRCA1/2 pathogenic variants, evidence remains limited for patients with pathogenic variants in other breast cancer susceptibility genes. This knowledge gap represents a relevant unmet need in oncofertility counseling and survivorship care.
The study will include patients diagnosed with stage I-III invasive breast cancer at age 40 years or younger between January 2000 and December 2025. The primary objectives are to assess the prognostic impact of pregnancy after breast cancer diagnosis and to evaluate the cumulative incidence of pregnancy in this population. Secondary objectives include the assessment of pregnancy, fetal, and obstetrical outcomes, the safety of assisted reproductive technology procedures, patterns of care including risk-reducing surgeries, survival outcomes according to clinicopathologic and genetic subgroups, and the occurrence of second primary malignancies.
Data will be collected retrospectively from participating centers within the Beyond BRCA BCY Collaboration.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant cohort | – | –Women with one or more pregnancies any time after breast cancer diagnosis |
| Non-pregnant cohort | – | –Women with no subsequent pregnancies after breast cancer diagnosis |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Young women diagnosed at age 40 years or younger with stage I-III invasive breast cancer between January 2000 and December 2025 and harboring a germline pathogenic variant in a breast cancer susceptibility gene other than BRCA1/2, including TP53, PALB2, PTEN, CDH1, STK11, CHEK2, ATM, BARD1, RAD51C, and RAD51D.
Key inclusion criteria (3 listed)
- Diagnosis of stage I-III invasive breast cancer between January 2000 and December 2025
- Age at breast cancer diagnosis ≤40 years
- Germline pathogenic variant in at least one of the following breast cancer susceptibility genes other than BRCA: TP53, PALB2, PTEN, CDH1, STK11, CHEK2, ATM, BARD1, RAD51C, or RAD51D
Key exclusion criteria (4 listed)
- Known germline pathogenic variant in breast cancer susceptibility genes without a diagnosis of invasive breast cancer
- Diagnosis of ovarian cancer or other malignancies without a prior history of invasive breast cancer
- Diagnosis of invasive breast cancer with germline variants of uncertain significance in breast cancer susceptibility genes
- De novo stage IV breast cancer
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
Cumulative Incidence of Pregnancy After Breast Cancer Diagnosis
Time frame: Up to 20 years from breast cancer diagnosis
Invasive Disease-Free Survival (iDFS)
Time frame: Up to 20 years from breast cancer diagnosis
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 15 May 2026.
- Individual participant dataSharing planned: Undecided. De-identified individual participant data may be shared upon reasonable request, subject to submission of a formal research proposal to the study Principal Investigators and review and approval by the study leadership. Any data sharing will be subject to applicable ethics approvals, data transfer agreements, local institutional requirements, and data protection regulations.
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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.
Luca Arecco, MD contact
Matteo Lambertini, MD, PhD principal investigator
IRCCS Azienda Ospedaliera Metropolitana
Evandro de Azambuja, MD, PhD principal investigator
Jules Bordet Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Breast Cancer and Pregnancy, run by Jules Bordet Institute.
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: opening soon, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Eva Blondeaux, MD (+39 010 555 8502, BCYcollaboration@aomliguria.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Incidence of Pregnancy After Breast Cancer Diagnosis (time frame: Up to 20 years from breast cancer diagnosis). The study lists 2 primary outcomes in all. 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 15 May 2026.