Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03673306




Registration number
NCT03673306
Ethics application status
Date submitted
13/09/2018
Date registered
17/09/2018
Date last updated
13/12/2024

Titles & IDs
Public title
Safety of Pregnancy in BRCA Mutated Breast Cancer Patients
Scientific title
A Multicenter Retrospective Study on the Prognostic Impact of Pregnancy in Women With History of BRCA Mutated Breast Cancer
Secondary ID [1] 0 0
IJB-BRCAPreg-CE2630
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Clinical outcomes

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


Other interventions: Clinical outcomes
Clinical outcomes
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease-free Survival
Timepoint [1] 0 0
10 years
Primary outcome [2] 0 0
Cumulative Incidence of Pregnancy After Breast Cancer
Timepoint [2] 0 0
10 years
Secondary outcome [1] 0 0
Breast Cancer-Specific Survival
Timepoint [1] 0 0
10 years
Secondary outcome [2] 0 0
Overall Survival
Timepoint [2] 0 0
10 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2023
Sample size
Target
Accrual to date
Final
4732
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
kConFab, Follow-up Project - Melbourne
Recruitment hospital [2] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Rhode Island
Country [8] 0 0
Argentina
State/province [8] 0 0
Buenos Aires
Country [9] 0 0
Austria
State/province [9] 0 0
Vienna
Country [10] 0 0
Belgium
State/province [10] 0 0
Brussels
Country [11] 0 0
Belgium
State/province [11] 0 0
Leuven
Country [12] 0 0
Bosnia and Herzegovina
State/province [12] 0 0
Sarajevo
Country [13] 0 0
Brazil
State/province [13] 0 0
Brasilia
Country [14] 0 0
Brazil
State/province [14] 0 0
São Paulo
Country [15] 0 0
Canada
State/province [15] 0 0
Montréal
Country [16] 0 0
France
State/province [16] 0 0
Bordeaux
Country [17] 0 0
France
State/province [17] 0 0
Lyon
Country [18] 0 0
France
State/province [18] 0 0
Paris
Country [19] 0 0
France
State/province [19] 0 0
Rouen
Country [20] 0 0
France
State/province [20] 0 0
Villejuif
Country [21] 0 0
Georgia
State/province [21] 0 0
Tiflis
Country [22] 0 0
Germany
State/province [22] 0 0
Hamburg
Country [23] 0 0
Germany
State/province [23] 0 0
München
Country [24] 0 0
India
State/province [24] 0 0
Mumbai
Country [25] 0 0
Israel
State/province [25] 0 0
Jerusalem
Country [26] 0 0
Israel
State/province [26] 0 0
Petah Tikva
Country [27] 0 0
Israel
State/province [27] 0 0
Tel Aviv
Country [28] 0 0
Italy
State/province [28] 0 0
Ancona
Country [29] 0 0
Italy
State/province [29] 0 0
Aviano
Country [30] 0 0
Italy
State/province [30] 0 0
Bergamo
Country [31] 0 0
Italy
State/province [31] 0 0
Cagliari
Country [32] 0 0
Italy
State/province [32] 0 0
Candiolo
Country [33] 0 0
Italy
State/province [33] 0 0
Florence
Country [34] 0 0
Italy
State/province [34] 0 0
Genova
Country [35] 0 0
Italy
State/province [35] 0 0
Grosseto
Country [36] 0 0
Italy
State/province [36] 0 0
Meldola
Country [37] 0 0
Italy
State/province [37] 0 0
Milan
Country [38] 0 0
Italy
State/province [38] 0 0
Modena
Country [39] 0 0
Italy
State/province [39] 0 0
Monza
Country [40] 0 0
Italy
State/province [40] 0 0
Naples
Country [41] 0 0
Italy
State/province [41] 0 0
Padova
Country [42] 0 0
Italy
State/province [42] 0 0
Pavia
Country [43] 0 0
Italy
State/province [43] 0 0
Pisa
Country [44] 0 0
Italy
State/province [44] 0 0
Prato
Country [45] 0 0
Italy
State/province [45] 0 0
Roma
Country [46] 0 0
Italy
State/province [46] 0 0
Rome
Country [47] 0 0
Korea, Republic of
State/province [47] 0 0
Seoul
Country [48] 0 0
Lebanon
State/province [48] 0 0
Beirut
Country [49] 0 0
Mexico
State/province [49] 0 0
Mexico City
Country [50] 0 0
Mexico
State/province [50] 0 0
Monterrey
Country [51] 0 0
Netherlands
State/province [51] 0 0
Amsterdam
Country [52] 0 0
Poland
State/province [52] 0 0
Gdansk
Country [53] 0 0
Poland
State/province [53] 0 0
Poznan
Country [54] 0 0
Poland
State/province [54] 0 0
Warsaw
Country [55] 0 0
Portugal
State/province [55] 0 0
Lisboa
Country [56] 0 0
Portugal
State/province [56] 0 0
Lisbon
Country [57] 0 0
Romania
State/province [57] 0 0
Cluj-Napoca
Country [58] 0 0
Serbia
State/province [58] 0 0
Belgrade
Country [59] 0 0
Serbia
State/province [59] 0 0
Novi Sad
Country [60] 0 0
Slovakia
State/province [60] 0 0
Bratislava
Country [61] 0 0
Spain
State/province [61] 0 0
Barcelona
Country [62] 0 0
Spain
State/province [62] 0 0
Madrid
Country [63] 0 0
Spain
State/province [63] 0 0
Palma De Mallorca
Country [64] 0 0
Spain
State/province [64] 0 0
Valencia
Country [65] 0 0
Sweden
State/province [65] 0 0
Stockholm
Country [66] 0 0
Switzerland
State/province [66] 0 0
Lugano

Funding & Sponsors
Primary sponsor type
Other
Name
Jules Bordet Institute
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?



Results publications and other study-related documents


Results are available at https://clinicaltrials.gov/study/NCT03673306