This trial is active, not recruiting.

Condition breast cancer
Treatment brca1 brca2 pten palb2 mutation
Sponsor Institut Paoli-Calmettes
Start date March 2011
End date August 2014
Trial size 200 participants
Trial identifier NCT01434420, SA03/IPC 2010-003


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Triple negative breast cancer
brca1 brca2 pten palb2 mutation BRCA1 BRCA2 PTEN PALB2 mutation
detection of BRCA1 BRCA2 PTEN PALB2 mutation

Primary Outcomes

incidence of BRCA1/2, PALB2, PTEN, PALB2 mutations
time frame: up to 1 month

Secondary Outcomes

molecular profiles
time frame: up to 1 month
years relapse-free survival
time frame: at 5 years

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - women > 18 - non metastatic breast cancer - triple negative - 5 years follow-up - signed informed consent Exclusion Criteria: - other cancer (except in situ) - metastases at diagnosis - impossibility of follow-up

Additional Information

Official title Triple Negative Breast Cancer: Study of Molecular and Genetic Factors
Principal investigator Jean-Marc EXTRA, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Institut Paoli-Calmettes.