Brief Summary

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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

200

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline

Completed

Started Mar 2011

Longer than P75 for not_applicable breast-cancer

Geographic Reach

1 country

4 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

9 years study duration

Study Start

First participant enrolled

March 1, 2011

Completed

7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2011

Completed

1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2011

Completed

2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed

5.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed

Last Updated

December 31, 2014

Status Verified

December 1, 2014

Enrollment Period

3.4 years

First QC Date

September 13, 2011

Last Update Submit

December 30, 2014

Conditions

Breast Cancer

Keywords

triple negative breast cancer

Outcome Measures

Primary Outcomes (1)

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
up to 1 month

Secondary Outcomes (2)

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

Study Arms (1)