Safety of Pregnancy in BRCA Mutated Breast Cancer Patients
- Conditions
- Breast Cancer
- Interventions
- Other: Clinical outcomes
- Registration Number
- NCT03673306
- Lead Sponsor
- Jules Bordet Institute
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 4732
- Diagnosis of invasive breast cancer between January 2000 and December 2020;
- Breast cancer diagnosis at the age of โค 40 years;
- Known presence of germline BRCA mutation.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pregnant cohort Clinical outcomes Women with one or more pregnancies any time after breast cancer diagnosis Non-pregnant cohort Clinical outcomes Women with no subsequent pregnancies after breast cancer diagnosis
- Primary Outcome Measures
Name Time Method Disease-free Survival 10 years The primary end points were the cumulative incidence of pregnancy and disease-free survival.
Cumulative Incidence of Pregnancy After Breast Cancer 10 years The primary end points were the cumulative incidence of pregnancy and disease-free survival.
- Secondary Outcome Measures
Name Time Method Breast Cancer-Specific Survival 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.
Overall Survival 10 years An overall survival event was defined as death due to any cause.
Trial Locations
- Locations (81)
Yale University
๐บ๐ธNew Haven, Connecticut, United States
Michigan State University
๐บ๐ธLansing, Michigan, United States
Mayo Clinic
๐บ๐ธRochester, Minnesota, United States
Cleveland Clinic Taussig Cancer Institute
๐บ๐ธCleveland, Ohio, United States
Lifespan Cancer Institute
๐บ๐ธProvidence, Rhode Island, United States
Hospital Aleman
๐ฆ๐ทBuenos Aires, Argentina
Hospital Italiano de Buenos Aires
๐ฆ๐ทBuenos Aires, Argentina
Instituto Alexander Fleming
๐ฆ๐ทBuenos Aires, Argentina
University of North Carolina - Lineberger Comprehensive Cancer Center
๐บ๐ธChapel Hill, North Carolina, United States
kConFab, Follow-up Project
๐ฆ๐บMelbourne, Victoria, Australia
Peter MacCallum Cancer Centre
๐ฆ๐บMelbourne, Victoria, Australia
Medical University of Vienna
๐ฆ๐นVienna, Austria
Clinical Center University of Sarajevo
๐ง๐ฆSarajevo, Bosnia and Herzegovina
Hospital Sรญrio-Libanรชs
๐ง๐ทBrasilia, Brazil
Mc Gill University
๐จ๐ฆMontrรฉal, Canada
Todua Clinic
๐ฌ๐ชTiflis, Georgia
Universitรคtsklinikum Hamburg-Eppendorf
๐ฉ๐ชHamburg, Germany
Leitung, Brustzentrum der Universitรคt Mรผnchen (LMU)
๐ฉ๐ชMรผnchen, Germany
Tata Memorial Centre
๐ฎ๐ณMumbai, India
Davidoff Cancer Center - Rabin Medical Center - Beilinson
๐ฎ๐ฑPetah Tikva, Israel
Universitร Politecnica delle Marche - Azienda Ospedaliero-Universitaria Ospedali Riuniti Umberto I - GM Lancisi - G Salesi
๐ฎ๐นAncona, Italy
Azienda Ospedaliero Universitaria di Cagliari
๐ฎ๐นCagliari, Italy
Florence University Hospital - University of Florence
๐ฎ๐นFlorence, Italy
Azienda USL Toscana Sud Est - Misericordia Hospital
๐ฎ๐นGrosseto, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
๐ฎ๐นMilan, Italy
IRCCS Ospedale San Raffaele
๐ฎ๐นMilan, Italy
IRCCS Ospedale Policlinico San Martino
๐ฎ๐นGenova, Italy
San Gerardo Hospital ASST Monza
๐ฎ๐นMonza, Italy
University of Naples "Federico II"
๐ฎ๐นNaples, Italy
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori
๐ฎ๐นMeldola, Italy
Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara
๐ฎ๐นPisa, Italy
Nuovo Ospedale di Prato - Santo Stefano
๐ฎ๐นPrato, Italy
ASL Roma 1 - Centro Oncologico S. Spirito - Nuovo Regina Margherita
๐ฎ๐นRome, Italy
Policlinico Universitario Agostino Gemelli IRCCS
๐ฎ๐นRome, Italy
University of Ulsan, College of Medicine, Asan medical center
๐ฐ๐ทSeoul, Korea, Republic of
Saint Joseph University of Beirut
๐ฑ๐งBeirut, Lebanon
Hospital Zambrano Hellion - Tecnologico de Monterrey
๐ฒ๐ฝMonterrey, Mexico
Netherlands Cancer Institute
๐ณ๐ฑAmsterdam, Netherlands
Medical University of Gdansk
๐ต๐ฑGdaลsk, Poland
Poznan University of Medical Sciences, University Hospital of H. Swiecicki
๐ต๐ฑPoznaล, Poland
Military institute of Medicine
๐ต๐ฑWarsaw, Poland
Champalimaud Foundation
๐ต๐นLisboa, Portugal
Institute of Oncology "Ion Chiricuta"
๐ท๐ดCluj-Napoca, Romania
Institute for Oncology and Radiology of Serbia
๐ท๐ธBelgrade, Serbia
Oncology Institute of Vojvodina - University of Novi Sad
๐ท๐ธNovi Sad, Serbia
St. Elisabeth Cancer Institute (Onkologicky ustav sv. Alzbety-OUSA)
๐ธ๐ฐBratislava, Slovakia
Hospital Clรญnic of Barcelona
๐ช๐ธBarcelona, Spain
Hospital Universitario 12 de Octubre
๐ช๐ธMadrid, Spain
Ramon y Cajal - IOB Institute of Oncology (Madrid) - International Breast Cancer Center (IBCC)
๐ช๐ธMadrid, Spain
Capio Saint Gรถran's Hospital
๐ธ๐ชStockholm, Sweden
Karolinska University Hospital
๐ธ๐ชStockholm, Sweden
Stockholm Southern Hospital (Sรถdersjukhuset)
๐ธ๐ชStockholm, Sweden
Dana-Farber Cancer Institute
๐บ๐ธBoston, Massachusetts, United States
Cliniques Universitaires Saint-Luc UCL
๐ง๐ชBrussels, Belgium
Institut Jules Bordet
๐ง๐ชBrussels, Belgium
University Hospitals Leuven, KU Leuven
๐ง๐ชLeuven, Belgium
Cancer Institute ICESP
๐ง๐ทSรฃo Paulo, Brazil
Bergonie Institute
๐ซ๐ทBordeaux, France
Leon Berard Cancer Center
๐ซ๐ทLyon, France
Hopital Saint Louis
๐ซ๐ทParis, France
Institut Curie
๐ซ๐ทParis, France
Centre Henri Becquerel
๐ซ๐ทRouen, France
Institut Gustave Roussy
๐ซ๐ทVillejuif, France
Sharett Institute of Oncology - Hadassah Hebrew University Medical Center
๐ฎ๐ฑJerusalem, Israel
Sheba Medical Center
๐ฎ๐ฑTel Aviv, Israel
Tel Aviv Sourasky Medical Center
๐ฎ๐ฑTel Aviv, Israel
Oncological Center CRO
๐ฎ๐นAviano, Italy
Azienda Ospedaliera "Papa Giovanni XXIII"
๐ฎ๐นBergamo, Italy
Candiolo Cancer Center (IRCCS)
๐ฎ๐นCandiolo, Italy
European Institute of Oncology
๐ฎ๐นMilan, Italy
Azienda Ospedaliero-Universitaria Policlinico, University of Modena and Reggio Emilia
๐ฎ๐นModena, Italy
IOV (Istituto Oncologico Veneto)
๐ฎ๐นPadova, Italy
IRCCS Policlinico San Matteo
๐ฎ๐นPavia, Italy
AOU Policlinico Umberto I
๐ฎ๐นRoma, Italy
Instituto Nacional de Cancerologia
๐ฒ๐ฝMexico City, Mexico
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
๐ต๐ฑWarsaw, Poland
Hospital de Santa Maria and Instituto de Medicina Molecular of the Faculty of Medicine of the University of Lisbon
๐ต๐นLisbon, Portugal
Vall D'Hebron University Hospital
๐ช๐ธBarcelona, Spain
Hospital Universitari Son Espases Palma
๐ช๐ธPalma De Mallorca, Spain
INCLIVA, University Hospital of Valencia
๐ช๐ธValencia, Spain
Oncology Institute of Southern Switzerland
๐จ๐ญLugano, Switzerland