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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

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
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United States of America
State/province [2] 0 0
Massachusetts
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United States of America
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Michigan
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United States of America
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Minnesota
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Rhode Island
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Argentina
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Buenos Aires
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Austria
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Vienna
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Belgium
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Brussels
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Belgium
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Leuven
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Bosnia and Herzegovina
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Sarajevo
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Brazil
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Brasilia
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Brazil
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São Paulo
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Canada
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Montréal
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France
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Bordeaux
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France
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Lyon
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France
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Paris
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France
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Rouen
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France
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Villejuif
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Georgia
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Tiflis
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Germany
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Hamburg
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Germany
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München
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India
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Mumbai
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Israel
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Jerusalem
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Israel
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Petah Tikva
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Israel
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Tel Aviv
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Italy
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Ancona
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Italy
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Aviano
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Italy
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Bergamo
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Italy
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Cagliari
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Italy
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Candiolo
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Italy
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Florence
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Italy
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Genova
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Italy
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Grosseto
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Italy
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Meldola
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Italy
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Milan
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Italy
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Modena
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Italy
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Monza
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Italy
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Naples
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Italy
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Padova
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Italy
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Pavia
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Italy
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Pisa
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Italy
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Prato
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Italy
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Roma
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Italy
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Rome
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Korea, Republic of
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Seoul
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Lebanon
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Beirut
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Mexico
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Mexico City
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Mexico
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Monterrey
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Netherlands
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Amsterdam
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Poland
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Gdansk
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Poland
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Poznan
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Poland
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Warsaw
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Portugal
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Lisboa
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Portugal
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Lisbon
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Romania
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Cluj-Napoca
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Serbia
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Belgrade
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Serbia
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Novi Sad
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Slovakia
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Bratislava
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Palma De Mallorca
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Spain
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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
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Undecided


What supporting documents are/will be available?




Results publications and other study-related documents



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