Triple Negative Breast Cancer: Study of Molecular and Genetic Factors
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|ClinicalTrials.gov Identifier: NCT01434420|
Recruitment Status : Active, not recruiting
First Posted : September 14, 2011
Last Update Posted : December 31, 2014
Breast cancer triples negatives (TN; 15 % of the cases) are characterized by a high histoprognostic grade, a strong proliferation, a strong metastatic power, and a worse prognosis than the other forms of breast cancer. It is however a heterogenous group for histological and molecular level, but also for evolution. Most of the TN is part of the basal breast cancer subcategory. Until now, the medical treatment is based on chemotherapy.
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Genetic: BRCA1 BRCA2 PTEN PALB2 mutation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Triple Negative Breast Cancer: Study of Molecular and Genetic Factors|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||August 2014|
|Estimated Study Completion Date :||March 2020|
Experimental: Triple negative breast cancer
Triple negative breast cancer
Genetic: BRCA1 BRCA2 PTEN PALB2 mutation
detection of BRCA1 BRCA2 PTEN PALB2 mutation
- incidence of BRCA1/2, PALB2, PTEN, PALB2 mutations [ Time Frame: up to 1 month ]1) Determine the incidence of the BRCA1/2, PALB2, PTEN, PALB2 mutations in patients having at diagnosis a non metastatic triple negative breast cancer
- molecular profiles [ Time Frame: up to 1 month ]2) Determine by tissue micro- array and transcriptome the molecular profiles and their correlation with the presence of a mutation
- years relapse-free survival [ Time Frame: at 5 years ]3) Determine the 5 years relapse-free survival in presence or not of a mutation, and according to the molecular profile of expression.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01434420
|Centre jean Perrin|
|Clermont-Ferrand, France, 63011|
|Hopital La Timone|
|Marseille, France, 13005|
|Marseille, France, 13009|
|Centre Antoine Lacassagne|
|Nice, France, 06189|
|Principal Investigator:||Jean-Marc EXTRA, MD||Institut Paoli-Calmettes|