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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant cohort | Women with one or more pregnancies any time after breast cancer diagnosis |
| |
| Non-pregnant cohort | Women with no subsequent pregnancies after breast cancer diagnosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical outcomes | Other | Clinical outcomes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free Survival | The primary end points were the cumulative incidence of pregnancy and disease-free survival. | 10 years |
| Cumulative Incidence of Pregnancy After Breast Cancer | The primary end points were the cumulative incidence of pregnancy and disease-free survival. | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 years |
| Overall Survival |
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Inclusion Criteria:
Exclusion Criteria:
Women only
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | United States | |||
| Dana-Farber Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32673153 | Result | 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. | |
| 38059899 |
| Label | URL |
|---|---|
| Related Info | View source |
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Undecided
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Subjects should meet all eligibility criteria and have available information on pregnancy status before assignment to groups
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregnant Cohort | Women with one or more pregnancies any time after breast cancer diagnosis Clinical outcomes: Clinical outcomes |
| FG001 | Non-pregnant Cohort | Women with no subsequent pregnancies after breast cancer diagnosis Clinical outcomes: Clinical outcomes |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 10, 2022 |
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An overall survival event was defined as death due to any cause.
| 10 years |
| Boston |
| Massachusetts |
| 02215 |
| 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 SÃrio-Libanês | BrasÃlia | 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) | Padova | 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 ClÃnic 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 |
| Result |
| 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. |
| 41260260 | Derived | Toss 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. |
| 40347973 | Derived | 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. |
| 39993249 | Derived | 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. |
| Related Info | View source |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregnant Cohort | Women with one or more pregnancies any time after breast cancer diagnosis Clinical outcomes: Clinical outcomes |
| BG001 | Non-pregnant Cohort | Women with no subsequent pregnancies after breast cancer diagnosis Clinical outcomes: Clinical outcomes |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Disease-free Survival | The primary end points were the cumulative incidence of pregnancy and disease-free survival. | A disease-free survival event was defined as the occurrence of 1 of the following invasive events: locoregional recurrence, distant metastases, new contralateral or ipsilateral invasive breast cancer, second primary malignancy, or death due to any cause. | Posted | Number | DFS events/100*person-year | 10 years |
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| Primary | Cumulative Incidence of Pregnancy After Breast Cancer | The primary end points were the cumulative incidence of pregnancy and disease-free survival. | Posted | Number | 95% Confidence Interval | Percentage (Cumulative incidence at 10y) | 10 years |
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| Secondary | 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. | Breast cancer-specific survival | Posted | Count of Participants | Participants | 10 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival | An overall survival event was defined as death due to any cause. | Posted | Count of Participants | Participants | 10 years |
|
|
10 years
All-Cause Mortality was recorded and is reported below. Adverse events were not collected. Please consider that this is a restrospective, observational study. No intervention was performed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pregnancy Cohort | Women with one or more pregnancies any time after breast cancer diagnosis | 39 | 659 | 0 | 0 | 0 | 0 |
| EG001 | No Pregnancy Cohort | Women with no pregnancies after breast cancer diagnosis | 570 | 4,073 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matteo Lambertini | IRCCS Ospedale Policlinico San Martino, Genoa, Italy | +39 010 555 4254 | matteo.lambertini@unige.it |
| Apr 26, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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