Not yet recruiting NCT07591532

Pregnancy Outcomes After Breast Cancer in Young Women With Germline Pathogenic Variants in Genes Other Than BRCA

— Observational Breast Cancer Breast Cancer and Pregnancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to: Registry conditions: Breast Cancer, Breast Cancer and Pregnancy. Basic parameters: 18 years — 40 years · Female.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Center list to be confirmed — check the primary protocol.
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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"

Overview

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.

Primary outcome measures

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]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07591532 · IJB-BEYOND-BCY-01

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗