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

NCT07591532 | Not Yet Recruiting

• 1 other identifier: IJB-BEYOND-BCY-01
• Study Type: observational
• Target: 2,200
• Locations: 0 countries
• Sites: N/A

Brief 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

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

Outcome Measures

Primary Outcomes (2)

• Cumulative Incidence of Pregnancy After Breast Cancer Diagnosis

  Up to 20 years from breast cancer diagnosis

• Invasive Disease-Free Survival (iDFS)

  Up to 20 years from breast cancer diagnosis

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jules Bordet Institute: lead

MeSH Terms

Conditions

Breast Neoplasms; Breast Cancer, Familial

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Matteo Lambertini, MD, PhD

  IRCCS Azienda Ospedaliera Metropolitana

  PRINCIPAL INVESTIGATOR

• Evandro de Azambuja, MD, PhD

  Jules Bordet Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Blondeaux, MD

CONTACT

+39 010 555 8502; BCYcollaboration@aomliguria.it

Luca Arecco, MD

CONTACT

BCYcollaboration@aomliguria.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 15, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 15, 2026

Record last verified: 2026-04