An interventional study of BRCA1 BRCA2 PTEN PALB2 mutation in Breast Cancer, sponsored by Institut Paoli-Calmettes. Status unknown at 4 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-31.
Sponsored by Institut Paoli-Calmettes · Not applicable and Interventional
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 200 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Institut Paoli-Calmettes is the lead sponsor of 168 studies on the registry; 50 are open to participants now.
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Exclusion Criteria:
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
1) Determine the incidence of the BRCA1/2, PALB2, PTEN, PALB2 mutations in patients having at diagnosis a non metastatic triple negative breast cancer
Time frame: up to 1 month
molecular profiles
2) Determine by tissue micro- array and transcriptome the molecular profiles and their correlation with the presence of a mutation
Time frame: up to 1 month
years relapse-free survival
3) Determine the 5 years relapse-free survival in presence or not of a mutation, and according to the molecular profile of expression.
Time frame: at 5 years
This study is status unknown, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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Institut Paoli-Calmettes