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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Aleman
      • 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
        • Universitätsklinikum 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 Gdańsk
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 16, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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