Triple Negative Breast Cancer: Study of Molecular and Genetic Factors

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Institut Paoli-Calmettes
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes
ClinicalTrials.gov Identifier:
NCT01434420
First received: September 13, 2011
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

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 Intervention
Breast Cancer
Genetic: BRCA1 BRCA2 PTEN PALB2 mutation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Triple Negative Breast Cancer: Study of Molecular and Genetic Factors

Resource links provided by NLM:


Further study details as provided by Institut Paoli-Calmettes:

Primary Outcome Measures:
  • incidence of BRCA1/2, PALB2, PTEN, PALB2 mutations [ Time Frame: up to 1 month ] [ Designated as safety issue: No ]
    1) Determine the incidence of the BRCA1/2, PALB2, PTEN, PALB2 mutations in patients having at diagnosis a non metastatic triple negative breast cancer


Secondary Outcome Measures:
  • molecular profiles [ Time Frame: up to 1 month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    3) Determine the 5 years relapse-free survival in presence or not of a mutation, and according to the molecular profile of expression.


Estimated Enrollment: 200
Study Start Date: March 2011
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Triple negative breast cancer
Triple negative breast cancer
Genetic: BRCA1 BRCA2 PTEN PALB2 mutation
detection of BRCA1 BRCA2 PTEN PALB2 mutation
Other Name: BRCA1 BRCA2 PTEN PALB2 mutation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01434420

Contacts
Contact: Dominique GENRE, MD 33491223778 drci.up@ipc.unicancer.fr
Contact: Agnès BOYER CHAMMARD, MD 33491223778 drci.up@ipc.unicancer.fr

Locations
France
Centre jean Perrin Recruiting
Clermont-Ferrand, France, 63011
Contact: Jean-Yves BIGNON, MD PhD         
Institut Paoli-Calmettes Recruiting
Marseille, France, 13009
Contact: Jean-Marc EXTRA, MD         
Hopital La Timone Recruiting
Marseille, France, 13005
Contact: Didier COWEN, MD PhD         
Centre Antoine Lacassagne Recruiting
Nice, France, 06189
Contact: Jean-Marc FERRERO, MD         
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
Principal Investigator: Jean-Marc EXTRA, MD Institut Paoli-Calmettes
  More Information

Additional Information:
No publications provided

Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT01434420     History of Changes
Other Study ID Numbers: SA03/IPC 2010-003
Study First Received: September 13, 2011
Last Updated: October 30, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Paoli-Calmettes:
triple negative breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 20, 2014