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Triple Negative Breast Cancer: Study of Molecular and Genetic Factors

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01434420
First Posted: September 14, 2011
Last Update Posted: December 31, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Institut Paoli-Calmettes
  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: None (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 ]
    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 ]
    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 ]
    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
Primary Completion Date: August 2014 (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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01434420


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

Additional Information:
Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT01434420     History of Changes
Other Study ID Numbers: SA03/IPC 2010-003
First Submitted: September 13, 2011
First Posted: September 14, 2011
Last Update Posted: December 31, 2014
Last Verified: December 2014

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

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