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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Metastasis
• Intervention / Treatment: Other: Blood sample for genetic analysis (Identification of germ line genetic factors that influence the risk of metastatic breast cancer)

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • BESANCON Cedex, France, 25030
    • Hôpital Jean Minjoz - CHU Besançon
  • Bordeaux, France, 33000
    • Institut Bergonie
  • Caen, France, 14000
    • Centre Francois Baclesse
  • DIJON Cedex, France, 21079
    • Centre Georges François Leclerc
  • Grenoble, France, 38028
    • Institut Daniel Hollard
  • LIMOGES Cedex, France, 87042
    • Hôpital Dupuytren
  • LYON Cedex 08, France, 69373
    • Centre Léon Bérard
  • Marseille, France, 13009
    • Institut Paoli Calmettes
  • Montpellier, France, 34000
    • Val d'Aurelle
  • Nice, France, 06000
    • Centre Antoine Lacassagne
  • PARIS Cedex 05, France, 75248
    • Institut Curie
  • Reims, France, 51100
    • Institut Jean Godinot
  • SAINT HERBLAIN Cedex, France, 44805
    • Centre René Gauducheau
  • Strasbourg, France, 67065
    • Centre Paul Strauss
  • TOULOUSE Cedex, France, 31052
    • Institut Claudius Regaud
  • Vandoeuvre les Nancy, France, 54511
    • Centre Alexis Vautrin
  • Villejuif, France, 94805
    • Institut Gustave Roussy

Participation Criteria

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blood samples	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Centre Leon Berard
• Collaborators: Centre de Recherche en Cancérologie de Lyon
• Investigators: Principal Investigator: Thomas Bachelot, MD, Centre Léon Bérard

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2011
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: August 2, 2011
• First Submitted That Met QC Criteria: October 24, 2011
• First Posted (Estimate): October 26, 2011

Study Record Updates

• Last Update Posted (Actual): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 14, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Germ line polymorphisms
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: STORM