Triple Negative Breast Cancer: Study of Molecular and Genetic Factors

Breast Cancer Clinical Trial

Official title:

Triple Negative Breast Cancer: Study of Molecular and Genetic Factors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01434420
• Other study ID #: SA03/IPC 2010-003
• Status: Active, not recruiting
• Phase: N/A
• First received: September 13, 2011
• Last updated: December 30, 2014
• Start date: March 2011
• Est. completion date: March 2020

Study information

• Verified date: December 2014
• Source: Institut Paoli-Calmettes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: March 2020
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Triple Negative Breast Neoplasms

Intervention

Genetic:
• BRCA1 BRCA2 PTEN PALB2 mutation
detection of BRCA1 BRCA2 PTEN PALB2 mutation

Locations

Country	Name	City	State
France	Centre jean Perrin	Clermont-Ferrand
France	Hopital La Timone	Marseille
France	Institut Paoli-Calmettes	Marseille
France	Centre Antoine Lacassagne	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	molecular profiles	2) Determine by tissue micro- array and transcriptome the molecular profiles and their correlation with the presence of a mutation	up to 1 month	No
Secondary	years relapse-free survival	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	No

External Links

•   sponsor web site