Clinical trial NCT03673306: Safety of Pregnancy in BRCA Mutated Breast Cancer Patients
Official title: A Multicenter Retrospective Study on the Prognostic Impact of Pregnancy in Women With History of BRCA Mutated Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast cancer
BRCA
Young
Survivorship
Lead sponsor: Jules Bordet Institute
Sponsor class: OTHER
First posted: 2018-09-17
Enrollment: 4732
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Disease-free Survival
timeFrame: 10 years
measure: Cumulative Incidence of Pregnancy After Breast Cancer
timeFrame: 10 years
Secondary outcomes:
measure: Breast Cancer-Specific Survival
timeFrame: 10 years
measure: Overall Survival
timeFrame: 10 years
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Lansing
country: United States
facility: Michigan State University
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Chapel Hill
country: United States
facility: University of North Carolina - Lineberger Comprehensive Cancer Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Institute
state: Ohio
city: Providence
country: United States
facility: Lifespan Cancer Institute
state: Rhode Island
city: Buenos Aires
country: Argentina
facility: Hospital Aleman
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Instituto Alexander Fleming
city: Melbourne
country: Australia
facility: kConFab, Follow-up Project
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc UCL
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Leuven
country: Belgium
facility: University Hospitals Leuven, KU Leuven
city: Sarajevo
country: Bosnia and Herzegovina
facility: Clinical Center University of Sarajevo
city: Brasilia
country: Brazil
facility: Hospital Sírio-Libanês
city: São Paulo
country: Brazil
facility: Cancer Institute ICESP
city: Montréal
country: Canada
facility: Mc Gill University
city: Bordeaux
country: France
facility: Bergonie Institute
city: Lyon
country: France
facility: Leon Berard Cancer Center
city: Paris
country: France
facility: Hopital Saint Louis
city: Paris
country: France
facility: Institut Curie
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Tiflis
country: Georgia
facility: Todua Clinic
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: München
country: Germany
facility: Leitung, Brustzentrum der Universität München (LMU)
city: Mumbai
country: India
facility: Tata Memorial Centre
city: Jerusalem
country: Israel
facility: Sharett Institute of Oncology - Hadassah Hebrew University Medical Center
city: Petah Tikva
country: Israel
facility: Davidoff Cancer Center - Rabin Medical Center - Beilinson
city: Tel Aviv
country: Israel
facility: Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Ancona
country: Italy
facility: Università Politecnica delle Marche - Azienda Ospedaliero-Universitaria Ospedali Riuniti Umberto I - GM Lancisi - G Salesi
city: Aviano
country: Italy
facility: Oncological Center CRO
city: Bergamo
country: Italy
facility: Azienda Ospedaliera "Papa Giovanni XXIII"
city: Cagliari
country: Italy
facility: Azienda Ospedaliero Universitaria di Cagliari
city: Candiolo
country: Italy
facility: Candiolo Cancer Center (IRCCS)
city: Florence
country: Italy
facility: Florence University Hospital - University of Florence
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
city: Grosseto
country: Italy
facility: Azienda USL Toscana Sud Est - Misericordia Hospital
city: Meldola
country: Italy
facility: IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori
city: Milan
country: Italy
facility: European Institute of Oncology
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Modena
country: Italy
facility: Azienda Ospedaliero-Universitaria Policlinico, University of Modena and Reggio Emilia
city: Monza
country: Italy
facility: San Gerardo Hospital ASST Monza
city: Naples
country: Italy
facility: University of Naples "Federico II"
city: Padova
country: Italy
facility: IOV (Istituto Oncologico Veneto)
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara
city: Prato
country: Italy
facility: Nuovo Ospedale di Prato - Santo Stefano
city: Roma
country: Italy
facility: AOU Policlinico Umberto I
city: Rome
country: Italy
facility: ASL Roma 1 - Centro Oncologico S. Spirito - Nuovo Regina Margherita
city: Rome
country: Italy
facility: Policlinico Universitario Agostino Gemelli IRCCS
city: Seoul
country: Korea, Republic of
facility: University of Ulsan, College of Medicine, Asan medical center
city: Beirut
country: Lebanon
facility: Saint Joseph University of Beirut
city: Mexico City
country: Mexico
facility: Instituto Nacional de Cancerologia
city: Monterrey
country: Mexico
facility: Hospital Zambrano Hellion - Tecnologico de Monterrey
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute
city: Gdańsk
country: Poland
facility: Medical University of Gdansk
city: Poznań
country: Poland
facility: Poznan University of Medical Sciences, University Hospital of H. Swiecicki
city: Warsaw
country: Poland
facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
city: Warsaw
country: Poland
facility: Military institute of Medicine
city: Lisboa
country: Portugal
facility: Champalimaud Foundation
city: Lisbon
country: Portugal
facility: Hospital de Santa Maria and Instituto de Medicina Molecular of the Faculty of Medicine of the University of Lisbon
city: Cluj-Napoca
country: Romania
facility: Institute of Oncology "Ion Chiricuta"
city: Belgrade
country: Serbia
facility: Institute for Oncology and Radiology of Serbia
city: Novi Sad
country: Serbia
facility: Oncology Institute of Vojvodina - University of Novi Sad
city: Bratislava
country: Slovakia
facility: St. Elisabeth Cancer Institute (Onkologicky ustav sv. Alzbety-OUSA)
city: Barcelona
country: Spain
facility: Hospital Clínic of Barcelona
city: Barcelona
country: Spain
facility: Vall D'Hebron University Hospital
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Ramon y Cajal - IOB Institute of Oncology (Madrid) - International Breast Cancer Center (IBCC)
city: Palma De Mallorca
country: Spain
facility: Hospital Universitari Son Espases Palma
city: Valencia
country: Spain
facility: INCLIVA, University Hospital of Valencia
city: Stockholm
country: Sweden
facility: Capio Saint Göran's Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Stockholm
country: Sweden
facility: Stockholm Southern Hospital (Södersjukhuset)
city: Lugano
country: Switzerland
facility: Oncology Institute of Southern Switzerland
Study officials:
References:
citation: 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.
citation: 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.