Triple Negative Breast Cancer: Study of Molecular and Genetic Factors
NCT ID: NCT01434420
Last Updated: 2014-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2011-03-31
2020-03-31
Brief Summary
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Breast cancers by constitutional mutation of BRCA1 / BRCA2 (5 % of breast cancers) are mostly of basal type and their prognostic seems better that what could be expected from high grade tumours and without hormonal receptors. They would be much more frequent in the TN group. However, at this day, no prospective study was led to estimate this incidence, or to study the intervention of other genes of predisposition, as well to analyse the links between this phenotype and their consequences at the germinal or somatic level, in terms of associated molecular changes and prognosis.
The purpose of this study is, on a prospective study, to lead a joined analysis at the germinal level, in search of mutations of the main genes of breast cancer predisposition (BRCA1/2, PALB2, PTEN, PALB2), and at the tumour level (tissue micro-array and transcriptome), by correlating these results to the main clinical parameters.
The 5 years relapse-free survival will also be estimated.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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Triple negative breast cancer
Triple negative breast cancer
BRCA1 BRCA2 PTEN PALB2 mutation
detection of BRCA1 BRCA2 PTEN PALB2 mutation
Interventions
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BRCA1 BRCA2 PTEN PALB2 mutation
detection of BRCA1 BRCA2 PTEN PALB2 mutation
Eligibility Criteria
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Inclusion Criteria
* non metastatic breast cancer
* triple negative
* 5 years follow-up
* signed informed consent
Exclusion Criteria
* metastases at diagnosis
* impossibility of follow-up
18 Years
FEMALE
No
Sponsors
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Institut Paoli-Calmettes
OTHER
Responsible Party
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Principal Investigators
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Jean-Marc EXTRA, MD
Role: PRINCIPAL_INVESTIGATOR
Institut Paoli-Calmettes
Locations
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Centre jean Perrin
Clermont-Ferrand, , France
Hopital La Timone
Marseille, , France
Institut Paoli-Calmettes
Marseille, , France
Centre Antoine Lacassagne
Nice, , France
Countries
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Related Links
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sponsor web site
Other Identifiers
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SA03/IPC 2010-003
Identifier Type: -
Identifier Source: org_study_id