Triple Negative Breast Cancer: Study of Molecular and Genetic Factors

December 30, 2014 updated by: Institut Paoli-Calmettes

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63011
        • Centre Jean Perrin
      • Marseille, France, 13009
        • Institut Paoli-Calmettes
      • Marseille, France, 13005
        • Hôpital La Timone
      • Nice, France, 06189
        • Centre Antoine Lacassagne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Triple negative breast cancer
Genetic: BRCA1 BRCA2 PTEN PALB2 mutation
detection of BRCA1 BRCA2 PTEN PALB2 mutation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 1 month
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.
at 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Paoli-Calmettes

Investigators

  • Principal Investigator: Jean-Marc EXTRA, MD, Institut Paoli-Calmettes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

August 1, 2014

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

September 13, 2011

First Submitted That Met QC Criteria

September 13, 2011

First Posted (Estimate)

September 14, 2011

Study Record Updates

Last Update Posted (Estimate)

December 31, 2014

Last Update Submitted That Met QC Criteria

December 30, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SA03/IPC 2010-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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