Breast CancerNCT03673306
Safety of Pregnancy in BRCA Mutated Breast Cancer Patients
An observational study of Breast Cancer, run by Jules Bordet Institute at 81 sites in 26 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Clinical outcomes
- How many people
- 4,732 participants
- Where
- 81 sitesin 26 countries
- Study dates
- 16 Jan 2017to Dec 2023
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
81 sites in 26 countries.
81 sites in 26 countries
Italy22 sites
Università Politecnica delle Marche - Azienda Ospedaliero-Universitaria Ospedali Riuniti Umberto I - GM Lancisi - G Salesi
Ancona
Oncological Center CRO
Aviano
Azienda Ospedaliera "Papa Giovanni XXIII"
Bergamo
Azienda Ospedaliero Universitaria di Cagliari
Cagliari
Candiolo Cancer Center (IRCCS)
Candiolo
Florence University Hospital - University of Florence
Florence
IRCCS Ospedale Policlinico San Martino
Genova
Azienda USL Toscana Sud Est - Misericordia Hospital
Grosseto
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori
Meldola
European Institute of Oncology
Milan
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan
IRCCS Ospedale San Raffaele
Milan
Azienda Ospedaliero-Universitaria Policlinico, University of Modena and Reggio Emilia
Modena
San Gerardo Hospital ASST Monza
Monza
University of Naples "Federico II"
Naples
IOV (Istituto Oncologico Veneto)
Padova
IRCCS Policlinico San Matteo
Pavia
Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara
Pisa
Nuovo Ospedale di Prato - Santo Stefano
Prato
AOU Policlinico Umberto I
Roma
ASL Roma 1 - Centro Oncologico S. Spirito - Nuovo Regina Margherita
Rome
Policlinico Universitario Agostino Gemelli IRCCS
Rome
United States7 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
University of North Carolina - Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina
Cleveland Clinic Taussig Cancer Institute
Cleveland, Ohio
Michigan State University
Lansing, Michigan
Yale University
New Haven, Connecticut
Lifespan Cancer Institute
Providence, Rhode Island
Mayo Clinic
Rochester, Minnesota
France6 sites
Bergonie Institute
Bordeaux
Leon Berard Cancer Center
Lyon
Hopital Saint Louis
Paris
Institut Curie
Paris
Centre Henri Becquerel
Rouen
Institut Gustave Roussy
Villejuif
Spain6 sites
Hospital Clínic of Barcelona
Barcelona
Vall D'Hebron University Hospital
Barcelona
Hospital Universitario 12 de Octubre
Madrid
Ramon y Cajal - IOB Institute of Oncology (Madrid) - International Breast Cancer Center (IBCC)
Madrid
Hospital Universitari Son Espases Palma
Palma de Mallorca
INCLIVA, University Hospital of Valencia
Valencia
Israel4 sites
Sharett Institute of Oncology - Hadassah Hebrew University Medical Center
Jerusalem
Davidoff Cancer Center - Rabin Medical Center - Beilinson
Petah Tikva
Sheba Medical Center
Tel Aviv
Tel Aviv Sourasky Medical Center
Tel Aviv
Poland4 sites
Medical University of Gdansk
Gdansk
Poznan University of Medical Sciences, University Hospital of H. Swiecicki
Poznan
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw
Military institute of Medicine
Warsaw
Argentina3 sites
Hospital Aleman
Buenos Aires
Hospital Italiano de Buenos Aires
Buenos Aires
Instituto Alexander Fleming
Buenos Aires
Belgium3 sites
Cliniques Universitaires Saint-Luc UCL
Brussels
Institut Jules Bordet
Brussels
University Hospitals Leuven, KU Leuven
Leuven
Sweden3 sites
Capio Saint Göran's Hospital
Stockholm
Karolinska University Hospital
Stockholm
Stockholm Southern Hospital (Södersjukhuset)
Stockholm
Australia2 sites
kConFab, Follow-up Project
Melbourne, Victoria
Peter MacCallum Cancer Centre
Melbourne, Victoria
Germany2 sites
Universitätsklinikum Hamburg-Eppendorf
Hamburg
Leitung, Brustzentrum der Universität München (LMU)
München
Mexico2 sites
Instituto Nacional de Cancerologia
Mexico City
Hospital Zambrano Hellion - Tecnologico de Monterrey
Monterrey
Portugal2 sites
Champalimaud Foundation
Lisbon
Hospital de Santa Maria and Instituto de Medicina Molecular of the Faculty of Medicine of the University of Lisbon
Lisbon
Serbia2 sites
Institute for Oncology and Radiology of Serbia
Belgrade
Oncology Institute of Vojvodina - University of Novi Sad
Novi Sad
Bosnia and Herzegovina1 site
Clinical Center University of Sarajevo
Sarajevo
Slovakia1 site
St. Elisabeth Cancer Institute (Onkologicky ustav sv. Alzbety-OUSA)
Bratislava
South Korea1 site
University of Ulsan, College of Medicine, Asan medical center
Seoul
About this study
Official title: 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.
- Conditions
- Breast Cancer
- Being tested
- Clinical outcomes
- Keywords
- Breast cancer, BRCA, Young, Survivorship
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical outcomesOther
Clinical outcomes
| Study group | Role | What they receive |
|---|---|---|
| Pregnant cohort | Women with one or more pregnancies any time after breast cancer diagnosis Receives: Other: Clinical outcomes | |
| Non-pregnant cohort | Women with no subsequent pregnancies after breast cancer diagnosis Receives: Other: Clinical outcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free Survival
The primary end points were the cumulative incidence of pregnancy and disease-free survival.
Measured: 10 years
Cumulative Incidence of Pregnancy After Breast Cancer
The primary end points were the cumulative incidence of pregnancy and disease-free survival.
Measured: 10 years
Secondary outcomes (2)
Breast Cancer-Specific Survival
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.
Measured: 10 years
Overall Survival
An overall survival event was defined as death due to any cause.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start16 Jan 2017
- Primary completionDec 2023
- Study completionDec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,732 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673306
- Sponsor's protocol ID
- IJB-BRCAPreg-CE2630
- Status last verified
- Feb 2024
- First submitted
- 13 Sep 2018
- Last updated
- 13 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Publications
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.
PubMed 32673153Lambertini 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.
PubMed 38059899Toss A, Blondeaux E, Tenedini E, Bonamici L, Graffeo R, Livraghi L, Villarreal-Garza C, Bernstein Molho R, Kwong A, Balmana J, Wildiers H, Agostinetto E, Phillips KA, Pogoda K, Renaud T, Rousset-Jablonski C, Ferrari A, Moore HCF, Peccatori FA, Paluch-Shimon S, Fruscio R, Micheri C, Wong SM, Cui W, Vernieri C, Lee MK, De Marchis L, Couch FJ, Del Mastro L, Puglisi F, Meireles PA, Kemp Z, Matikas A, Plichta J, Del Pilar Estevez-Diz M, Di Meglio A, Cichowska-Cwalinska N, Gianni C, Yerushalmi R, Sanchez-Bayona R, Mrinakova B, Matos L, Bianchini G, Caleffi M, Krivokuca A, Abdou Y, Marino-Marino M, Parokonnaya A, Okano M, Antone N, Saavedra C, Sonnenblick A, Duchnowska R, Pais HL, Harbeck N, Cortesi L, Delucchi V, De Angelis C, Lambertini M. Association between type and location of germline BRCA1/2 pathogenic or likely pathogenic variants with phenotype and prognosis in young patients with breast cancer: results from an international cohort study. Ann Oncol. 2026 Mar;37(3):364-377. doi: 10.1016/j.annonc.2025.11.004. Epub 2025 Nov 17.
PubMed 41260260Blondeaux 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.
PubMed 40347973Lambertini 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.
PubMed 39993249