Evaluation of the Predictive and Prognostic Value of Germ-line Polymorphisms in Patients With Metastatic Breast Cancer

Breast Cancer Clinical Trial

— StoRM  

Official title:

Evaluation of the Predictive and Prognostic Value of Germ-line Polymorphisms in Patients With Metastatic Breast Cancer : a Multicenter Non-randomized Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01460186
• Other study ID #: StoRM
• Status: Completed
• Phase: N/A
• Start date: December 2011
• Est. completion date: September 1, 2017

Study information

• Verified date: January 2019
• Source: Centre Leon Berard
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, non-randomized, prospective cohort study. The purpose of the study is to identify germ line genetic factors that influence the risk of metastatic breast cancer.

1500 patients will be enrolled in this study. Blood samples will be collected after informed consent and inclusion in the study.

Patients will be treated and followed according to the standards of their treating center.

They will be followed during at least 5 years every 6 months for 3 years then every year.

Description:

The StoRM trial is designed for analysis in association with the SIGNAL study which aims to decipher the genetic risk of breast cancer displaying amplification of the HER2 gene as well as resistance or toxicity to adjuvant treatments. SIGNAL study is in the process of recruiting 6000 localized breast cancer patients.

The purpose of the StoRM trial is to create a cohort of 1500 patients with metastatic breast cancer including detailed epidemiologic and treatment data. Using germ line polymorphisms in these patients and comparing them to patients with localized cancer from the SIGNAL study, the investigators will answer questions specific to the genetic influence on the prognosis of breast cancer and its response to treatments in the metastatic phase.

Blood samples will be collected in one 6 ml EDTA and one 6 ml ACD tube after informed consent and inclusion in the study. To simplify the evolution of the study and to avoid all confusion, the sample collection procedures followed will be identical to those used in the SIGNAL study.

As the samples are received at the biological resource center, the plasma will be aliquoted into a 500 µl tube and frozen at -80° C. DNA will be extracted using standard protocols. Plasma and DNA will be stored in anticipation of genetic analyses. An aliquot of the DNA sample will be genotyped for a panel of high-density genetic markers covering the whole genome, for genome-wide association studies.

The collected plasma may also be used for analyses to determine the expression profile of proteins, alone or combined with genetic factors that allow distinguishing between groups of patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: September 1, 2017
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women with a histologically proven breast adenocarcinoma, with metastatic progression diagnosed within one year (inclusion of patients who have a metastatic progression more than one year ago would favor the inclusion of patients with indolent cancer, possibly biasing the study) or locally advanced (no curative treatment)

• ER, PR and HER2 status known

• Age >= 18 years

• Affiliation with a social security scheme

• Signed informed consent

Exclusion Criteria:

• Coexisting or other cancer diagnosed within the previous 5 years that may be responsible for the current metastasis

• Patient who cannot follow medical surveillance due to geographical, social or psychological reasons

• Patient included in the SIGNAL study

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Metastasis

Intervention

Other:
• Blood sample for genetic analysis (Identification of germ line genetic factors that influence the risk of metastatic breast cancer)
Blood samples will be collected in one 6 ml EDTA and one 6 ml ACD tube after informed consent and inclusion in the study.

Locations

Country	Name	City	State
France	Hôpital Jean Minjoz - CHU Besançon	BESANCON Cedex
France	Institut Bergonié	Bordeaux
France	Centre François Baclesse	Caen
France	Centre Georges François Leclerc	DIJON Cedex
France	Institut Daniel Hollard	Grenoble
France	Hôpital Dupuytren	LIMOGES Cedex
France	Centre Léon Bérard	LYON Cedex 08
France	Institut Paoli Calmettes	Marseille
France	Val d'Aurelle	Montpellier
France	Centre Antoine Lacassagne	Nice
France	Institut Curie	PARIS Cedex 05
France	Institut Jean Godinot	Reims
France	Centre René Gauducheau	SAINT HERBLAIN Cedex
France	Centre Paul Strauss	Strasbourg
France	Institut Claudius Regaud	TOULOUSE Cedex
France	Centre Alexis Vautrin	Vandoeuvre les Nancy
France	Institut Gustave Roussy	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
Centre Leon Berard	Centre de Recherche en Cancérologie de Lyon

Country where clinical trial is conducted

France, 

References & Publications (14)

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* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Germ line genetic factors associated with metastatic relapse	Genetic determinants that predispose to a metastatic relapse of brest cancer by establishing germ line genetic variation based on single nucleotide polymorphisms of patients with metastatic breast cancer and comparing this variation to a cohort of patients with localized breast cancer (SIGNAL study)(correlation between polymorphisms and risk of relapse)	at the end of enrollment (2 years)
Secondary	Genetic determinants that predispose to specific metastatic localizations	Germ line polymorphisms will be analysed and tested for association with specific metastatic localizations as bone, lung, liver or central nervous system.	at the end of enrollment (2 years)
Secondary	Genetic determinants that predispose to metastatic relapse of specific molecular subtype of breast cancer	Germ line polymorphisms will be analysed and tested for association with metastatic relapse as a function of immunohistochemical/molecular characteristics of the primary tumor	at the end of enrollment (2 years)
Secondary	Overall survival	Evaluate as a function of germ line polymorphisms overall survival after first-line treatment in metastatic setting	At the end of the study (7 years: 2 years of enrollment and 5 years of follow-up)
Secondary	Progression free survival	Evaluate as a function of germ line polymorphisms progression free survival after first-line treatment in metastatic setting	At the end of the study (7 years: 2 years of enrollment and 5 years of follow-up)