Safety of Pregnancy in BRCA Mutated Breast Cancer Patients

October 28, 2024 updated by: Jules Bordet Institute

A Multicenter Retrospective Study on the Prognostic Impact of Pregnancy in Women With History of BRCA Mutated Breast Cancer

The present study aims at refining the understanding of the effect of pregnancy on breast cancer outcomes in the specific population of BRCA mutated patients with known history of breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

4732

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Hospital Italiano de Buenos Aires
      • Buenos Aires, Argentina
        • Hospital Alemán
      • Buenos Aires, Argentina
        • Instituto Alexander Fleming
  • Australia
    • Victoria
      • Melbourne, Victoria, Australia
        • Peter MacCallum Cancer Centre
      • Melbourne, Victoria, Australia
        • kConFab, Follow-up Project
  • Austria
      • Vienna, Austria
        • Medical University of Vienna
  • Belgium
      • Brussels, Belgium
        • Institut Jules Bordet
      • Brussels, Belgium
        • Cliniques Universitaires Saint-Luc UCL
      • Leuven, Belgium
        • University Hospitals Leuven, KU Leuven
  • Bosnia and Herzegovina
      • Sarajevo, Bosnia and Herzegovina
        • Clinical Center University of Sarajevo
  • Brazil
      • Brasilia, Brazil
        • Hospital Sírio-Libanês
      • São Paulo, Brazil
        • Cancer Institute ICESP
  • Canada
      • Montréal, Canada
        • Mc Gill University
  • France
      • Bordeaux, France
        • Bergonie Institute
      • Lyon, France
        • Leon Berard Cancer Center
      • Paris, France
        • Hopital saint Louis
      • Paris, France
        • Institut Curie
      • Rouen, France
        • Centre Henri Becquerel
      • Villejuif, France
        • Institut Gustave Roussy
  • Georgia
      • Tiflis, Georgia
        • Todua Clinic
  • Germany
      • Hamburg, Germany
        • Universitatsklinikum Hamburg-Eppendorf
      • München, Germany
        • Leitung, Brustzentrum der Universität München (LMU)
  • India
      • Mumbai, India
        • Tata Memorial Centre
  • Israel
      • Jerusalem, Israel
        • Sharett Institute of Oncology - Hadassah Hebrew University Medical Center
      • Petah Tikva, Israel
        • Davidoff Cancer Center - Rabin Medical Center - Beilinson
      • Tel Aviv, Israel
        • Sheba Medical Center
      • Tel Aviv, Israel
        • Tel Aviv Sourasky Medical Center
  • Italy
      • Ancona, Italy
        • Università Politecnica delle Marche - Azienda Ospedaliero-Universitaria Ospedali Riuniti Umberto I - GM Lancisi - G Salesi
      • Aviano, Italy
        • Oncological Center CRO
      • Bergamo, Italy
        • Azienda Ospedaliera "Papa Giovanni XXIII"
      • Cagliari, Italy
        • Azienda Ospedaliero Universitaria di Cagliari
      • Candiolo, Italy
        • Candiolo Cancer Center (IRCCS)
      • Florence, Italy
        • Florence University Hospital - University of Florence
      • Genova, Italy
        • IRCCS Ospedale Policlinico San Martino
      • Grosseto, Italy
        • Azienda USL Toscana Sud Est - Misericordia Hospital
      • Meldola, Italy
        • IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori
      • Milan, Italy
        • European Institute of Oncology
      • Milan, Italy
        • Irccs Ospedale San Raffaele
      • Milan, Italy
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Modena, Italy
        • Azienda Ospedaliero-Universitaria Policlinico, University of Modena and Reggio Emilia
      • Monza, Italy
        • San Gerardo Hospital ASST Monza
      • Naples, Italy
        • University of Naples "Federico II"
      • Padova, Italy
        • IOV (Istituto Oncologico Veneto)
      • Pavia, Italy
        • IRCCS Policlinico San Matteo
      • Pisa, Italy
        • Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara
      • Prato, Italy
        • Nuovo Ospedale di Prato - Santo Stefano
      • Roma, Italy
        • AOU Policlinico Umberto I
      • Rome, Italy
        • ASL Roma 1 - Centro Oncologico S. Spirito - Nuovo Regina Margherita
      • Rome, Italy
        • Policlinico Universitario Agostino Gemelli IRCCS
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • University of Ulsan, College of Medicine, Asan medical center
  • Lebanon
      • Beirut, Lebanon
        • Saint Joseph University of Beirut
  • Mexico
      • Mexico City, Mexico
        • Instituto Nacional de Cancerologia
      • Monterrey, Mexico
        • Hospital Zambrano Hellion - Tecnologico de Monterrey
  • Netherlands
      • Amsterdam, Netherlands
        • Netherlands Cancer Institute
  • Poland
      • Gdańsk, Poland
        • Medical University of Gdansk
      • Poznań, Poland
        • Poznan University of Medical Sciences, University Hospital of H. Swiecicki
      • Warsaw, Poland
        • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
      • Warsaw, Poland
        • Military Institute of Medicine
  • Portugal
      • Lisboa, Portugal
        • Champalimaud Foundation
      • Lisbon, Portugal
        • Hospital de Santa Maria and Instituto de Medicina Molecular of the Faculty of Medicine of the University of Lisbon
  • Romania
      • Cluj-Napoca, Romania
        • Institute of Oncology "Ion Chiricuta"
  • Serbia
      • Belgrade, Serbia
        • Institute for Oncology and Radiology of Serbia
      • Novi Sad, Serbia
        • Oncology Institute of Vojvodina - University of Novi Sad
  • Slovakia
      • Bratislava, Slovakia
        • St. Elisabeth Cancer Institute (Onkologicky ustav sv. Alzbety-OUSA)
  • Spain
      • Barcelona, Spain
        • Vall d'Hebron University Hospital
      • Barcelona, Spain
        • Hospital Clinic of Barcelona
      • Madrid, Spain
        • Hospital Universitario 12 de octubre
      • Madrid, Spain
        • Ramon y Cajal - IOB Institute of Oncology (Madrid) - International Breast Cancer Center (IBCC)
      • Palma De Mallorca, Spain
        • Hospital Universitari Son Espases Palma
      • Valencia, Spain
        • INCLIVA, University Hospital of Valencia
  • Sweden
      • Stockholm, Sweden
        • Karolinska University Hospital
      • Stockholm, Sweden
        • Capio Saint Göran's Hospital
      • Stockholm, Sweden
        • Stockholm Southern Hospital (Södersjukhuset)
  • Switzerland
      • Lugano, Switzerland
        • Oncology Institute of Southern Switzerland
  • United States
    • Connecticut
      • New Haven, Connecticut, United States
        • Yale University
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
    • Michigan
      • Lansing, Michigan, United States
        • Michigan State University
    • Minnesota
      • Rochester, Minnesota, United States
        • Mayo Clinic
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • University of North Carolina - Lineberger Comprehensive Cancer Center
    • Ohio
      • Cleveland, Ohio, United States
        • Cleveland Clinic Taussig Cancer Institute
    • Rhode Island
      • Providence, Rhode Island, United States
        • Lifespan Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with diagnosis of invasive breast cancer between January 2000 and December 2020 at the age of ≤ 40 years and with known presence of germline BRCA mutation.

Description

Inclusion Criteria:

  • Diagnosis of invasive breast cancer between January 2000 and December 2020;
  • Breast cancer diagnosis at the age of ≤ 40 years;
  • Known presence of germline BRCA mutation.

Exclusion Criteria:

  • Known BRCA mutation with no diagnosis of invasive breast cancer;
  • Diagnosis of ovarian cancer or other malignancies with no history of invasive breast cancer;
  • Diagnosis of hereditary or familiar invasive breast cancer without BRCA mutation or with BRCA genes not tested;
  • Diagnosis of invasive breast cancer with germline BRCA variants of unknown significance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pregnant cohort
Women with one or more pregnancies any time after breast cancer diagnosis
Other: Clinical outcomes
Clinical outcomes
Non-pregnant cohort
Women with no subsequent pregnancies after breast cancer diagnosis
Other: Clinical outcomes
Clinical outcomes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free Survival
Time Frame: 10 years
The primary end points were the cumulative incidence of pregnancy and disease-free survival.
10 years
Cumulative Incidence of Pregnancy After Breast Cancer
Time Frame: 10 years
The primary end points were the cumulative incidence of pregnancy and disease-free survival.
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breast Cancer-Specific Survival
Time Frame: 10 years
A breast cancer-specific survival event was defined as death due to breast cancer, and patients who died for reasons other than breast cancer were censored at the date of death.
10 years
Overall Survival
Time Frame: 10 years
An overall survival event was defined as death due to any cause.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jules Bordet Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2017

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

September 13, 2018

First Submitted That Met QC Criteria

September 14, 2018

First Posted (Actual)

September 17, 2018

Study Record Updates

Last Update Posted (Actual)

December 13, 2024

Last Update Submitted That Met QC Criteria

October 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IJB-BRCAPreg-CE2630

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Clinical outcomes

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe