Safety of Pregnancy in BRCA Mutated Breast Cancer Patients
NCT ID: NCT03673306
Last Updated: 2024-12-13
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
4732 participants
OBSERVATIONAL
2017-01-16
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Pregnant cohort
Women with one or more pregnancies any time after breast cancer diagnosis
Clinical outcomes
Clinical outcomes
Non-pregnant cohort
Women with no subsequent pregnancies after breast cancer diagnosis
Clinical outcomes
Clinical outcomes
Interventions
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Clinical outcomes
Clinical outcomes
Eligibility Criteria
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Inclusion Criteria
* Breast cancer diagnosis at the age of ≤ 40 years;
* Known presence of germline BRCA mutation.
Exclusion Criteria
* 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.
18 Years
40 Years
FEMALE
No
Sponsors
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Jules Bordet Institute
OTHER
Responsible Party
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Locations
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Yale University
New Haven, Connecticut, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Michigan State University
Lansing, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
University of North Carolina - Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Cleveland Clinic Taussig Cancer Institute
Cleveland, Ohio, United States
Lifespan Cancer Institute
Providence, Rhode Island, United States
Hospital Aleman
Buenos Aires, , Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, , Argentina
Instituto Alexander Fleming
Buenos Aires, , Argentina
kConFab, Follow-up Project
Melbourne, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Medical University of Vienna
Vienna, , Austria
Cliniques Universitaires Saint-Luc UCL
Brussels, , Belgium
Institut Jules Bordet
Brussels, , Belgium
University Hospitals Leuven, KU Leuven
Leuven, , Belgium
Clinical Center University of Sarajevo
Sarajevo, , Bosnia and Herzegovina
Hospital Sírio-Libanês
Brasília, , Brazil
Cancer Institute ICESP
São Paulo, , Brazil
Mc Gill University
Montreal, , Canada
Bergonie Institute
Bordeaux, , France
Leon Berard Cancer Center
Lyon, , France
Hopital Saint Louis
Paris, , France
Institut Curie
Paris, , France
Centre Henri Becquerel
Rouen, , France
Institut Gustave Roussy
Villejuif, , France
Todua Clinic
Tbilisi, , Georgia
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Leitung, Brustzentrum der Universität München (LMU)
München, , Germany
Tata Memorial Centre
Mumbai, , India
Sharett Institute of Oncology - Hadassah Hebrew University Medical Center
Jerusalem, , Israel
Davidoff Cancer Center - Rabin Medical Center - Beilinson
Petah Tikva, , Israel
Sheba Medical Center
Tel Aviv, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Università Politecnica delle Marche - Azienda Ospedaliero-Universitaria Ospedali Riuniti Umberto I - GM Lancisi - G Salesi
Ancona, , Italy
Oncological Center CRO
Aviano, , Italy
Azienda Ospedaliera "Papa Giovanni XXIII"
Bergamo, , Italy
Azienda Ospedaliero Universitaria di Cagliari
Cagliari, , Italy
Candiolo Cancer Center (IRCCS)
Candiolo, , Italy
Florence University Hospital - University of Florence
Florence, , Italy
IRCCS Ospedale Policlinico San Martino
Genova, , Italy
Azienda USL Toscana Sud Est - Misericordia Hospital
Grosseto, , Italy
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori
Meldola, , Italy
European Institute of Oncology
Milan, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
IRCCS Ospedale San Raffaele
Milan, , Italy
Azienda Ospedaliero-Universitaria Policlinico, University of Modena and Reggio Emilia
Modena, , Italy
San Gerardo Hospital ASST Monza
Monza, , Italy
University of Naples "Federico II"
Naples, , Italy
IOV (Istituto Oncologico Veneto)
Padua, , Italy
IRCCS Policlinico San Matteo
Pavia, , Italy
Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara
Pisa, , Italy
Nuovo Ospedale di Prato - Santo Stefano
Prato, , Italy
AOU Policlinico Umberto I
Roma, , Italy
ASL Roma 1 - Centro Oncologico S. Spirito - Nuovo Regina Margherita
Rome, , Italy
Policlinico Universitario Agostino Gemelli IRCCS
Rome, , Italy
Saint Joseph University of Beirut
Beirut, , Lebanon
Instituto Nacional de Cancerologia
Mexico City, , Mexico
Hospital Zambrano Hellion - Tecnologico de Monterrey
Monterrey, , Mexico
Netherlands Cancer Institute
Amsterdam, , Netherlands
Medical University of Gdansk
Gdansk, , Poland
Poznan University of Medical Sciences, University Hospital of H. Swiecicki
Poznan, , Poland
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, , Poland
Military institute of Medicine
Warsaw, , Poland
Champalimaud Foundation
Lisbon, , Portugal
Hospital de Santa Maria and Instituto de Medicina Molecular of the Faculty of Medicine of the University of Lisbon
Lisbon, , Portugal
Institute of Oncology "Ion Chiricuta"
Cluj-Napoca, , Romania
Institute for Oncology and Radiology of Serbia
Belgrade, , Serbia
Oncology Institute of Vojvodina - University of Novi Sad
Novi Sad, , Serbia
St. Elisabeth Cancer Institute (Onkologicky ustav sv. Alzbety-OUSA)
Bratislava, , Slovakia
University of Ulsan, College of Medicine, Asan medical center
Seoul, , South Korea
Hospital Clínic of Barcelona
Barcelona, , Spain
Vall D'Hebron University Hospital
Barcelona, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Ramon y Cajal - IOB Institute of Oncology (Madrid) - International Breast Cancer Center (IBCC)
Madrid, , Spain
Hospital Universitari Son Espases Palma
Palma de Mallorca, , Spain
INCLIVA, University Hospital of Valencia
Valencia, , Spain
Capio Saint Göran's Hospital
Stockholm, , Sweden
Karolinska University Hospital
Stockholm, , Sweden
Stockholm Southern Hospital (Södersjukhuset)
Stockholm, , Sweden
Oncology Institute of Southern Switzerland
Lugano, , Switzerland
Countries
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References
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Lambertini M, Ameye L, Hamy AS, Zingarello A, Poorvu PD, Carrasco E, Grinshpun A, Han S, Rousset-Jablonski C, Ferrari A, Paluch-Shimon S, Cortesi L, Senechal C, Miolo G, Pogoda K, Perez-Fidalgo JA, De Marchis L, Ponzone R, Livraghi L, Estevez-Diz MDP, Villarreal-Garza C, Dieci MV, Clatot F, Berliere M, Graffeo R, Teixeira L, Cordoba O, Sonnenblick A, Luna Pais H, Ignatiadis M, Paesmans M, Partridge AH, Caron O, Saule C, Del Mastro L, Peccatori FA, Azim HA Jr. Pregnancy After Breast Cancer in Patients With Germline BRCA Mutations. J Clin Oncol. 2020 Sep 10;38(26):3012-3023. doi: 10.1200/JCO.19.02399. Epub 2020 Jul 16.
Lambertini M, Blondeaux E, Agostinetto E, Hamy AS, Kim HJ, Di Meglio A, Bernstein Molho R, Hilbers F, Pogoda K, Carrasco E, Punie K, Bajpai J, Ignatiadis M, Moore HCF, Phillips KA, Toss A, Rousset-Jablonski C, Peccatori FA, Renaud T, Ferrari A, Paluch-Shimon S, Fruscio R, Cui W, Wong SM, Vernieri C, Ruddy KJ, Dieci MV, Matikas A, Rozenblit M, Villarreal-Garza C, De Marchis L, Del Mastro L, Puglisi F, Del Pilar Estevez-Diz M, Rodriguez-Wallberg KA, Mrinakova B, Meister S, Livraghi L, Clatot F, Yerushalmi R, De Angelis C, Sanchez-Bayona R, Meattini I, Cichowska-Cwalinska N, Berliere M, Salama M, De Giorgi U, Sonnenblick A, Chiodi C, Lee YJ, Maria C, Azim HA Jr, Boni L, Partridge AH; BRCA BCY Collaboration. Pregnancy After Breast Cancer in Young BRCA Carriers: An International Hospital-Based Cohort Study. JAMA. 2024 Jan 2;331(1):49-59. doi: 10.1001/jama.2023.25463.
Blondeaux E, Sonnenblick A, Agostinetto E, Bas R, Kim HJ, Franzoi MA, Bernstein-Molho R, Linn S, Kwong A, Pogoda K, Balmana J, Smeets A, Bajpai J, Moore HCF, Partridge AH, Phillips KA, Toss A, Rousset-Jablonski C, Peccatori FA, Renaud T, Ferrari A, Paluch-Shimon S, Mando P, Lee JE, Fruscio R, Cui W, Wong SM, Vernieri C, Ruddy KJ, Dieci MV, Matikas A, Rozenblit M, Guven DC, Lee M, Villarreal-Garza C, Hwang SE, De Marchis L, Puglisi F, Kemp Z, Meireles PA, Parokonnaya A, Werutsky G, Okano M, Azim HA Jr, Mati K, Rosenberg S, Gelber R, Boni L, Lambertini M. Association between risk-reducing surgeries and survival in young BRCA carriers with breast cancer: an international cohort study. Lancet Oncol. 2025 Jun;26(6):759-770. doi: 10.1016/S1470-2045(25)00152-4. Epub 2025 May 8.
Lambertini M, Blondeaux E, Tomasello LM, Agostinetto E, Hamy AS, Kim HJ, Franzoi MA, Bernstein-Molho R, Hilbers F, Pogoda K, Wildiers H, Bajpai J, Ignatiadis M, Moore HCF, Partridge AH, Phillips KA, Toss A, Rousset-Jablonski C, Criscitiello C, Renaud T, Ferrari A, Paluch-Shimon S, Fruscio R, Cui W, Wong SM, Vernieri C, Ruddy KJ, Dieci MV, Matikas A, Rozenblit M, Villarreal-Garza C, De Marchis L, Puglisi F, Rodriguez-Wallberg KA, Duhoux FP, Livraghi L, Bruzzone M, Boni L, Balmana J. Clinical Behavior of Breast Cancer in Young BRCA Carriers and Prediagnostic Awareness of Germline BRCA Status. J Clin Oncol. 2025 May 10;43(14):1706-1719. doi: 10.1200/JCO-24-01334. Epub 2025 Feb 24.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Related Info
Related Info
Other Identifiers
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IJB-BRCAPreg-CE2630
Identifier Type: -
Identifier Source: org_study_id