Pregnancy Outcomes After Breast Cancer in Young Women With Germline Pathogenic Variants in Genes Other Than BRCA (Beyond BCY)
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"
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Eva Blondeaux, MD
- Telefonnummer: +39 010 555 8502
- E-post: BCYcollaboration@aomliguria.it
Studer Kontakt Backup
- Navn: Luca Arecco, MD
- E-post: BCYcollaboration@aomliguria.it
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
Gravid kohort
Kvinner med en eller flere graviditeter når som helst etter diagnosen brystkreft
|
|
Ikke-gravid kohort
Kvinner uten påfølgende graviditet etter brystkreftdiagnose
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Cumulative Incidence of Pregnancy After Breast Cancer Diagnosis
Tidsramme: Up to 20 years from breast cancer diagnosis
|
Up to 20 years from breast cancer diagnosis
|
|
Invasive Disease-Free Survival (iDFS)
Tidsramme: Up to 20 years from breast cancer diagnosis
|
Up to 20 years from breast cancer diagnosis
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Matteo Lambertini, MD, PhD, IRCCS Azienda Ospedaliera Metropolitana
- Hovedetterforsker: Evandro de Azambuja, MD, PhD, Jules Bordet Institute
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IJB-BEYOND-BCY-01
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .