Clinical trial NCT01460186: Evaluation of the Predictive and Prognostic Value of Germ-line Polymorphisms in Patients With Metastatic Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Metastasis
Keywords: Germ line polymorphisms
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
Collaborators: name: Centre de Recherche en Cancérologie de Lyon
First posted: 2011-10-26
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Germ line genetic factors associated with metastatic relapse
timeFrame: at the end of enrollment (2 years)
Secondary outcomes:
measure: Genetic determinants that predispose to specific metastatic localizations
timeFrame: at the end of enrollment (2 years)
measure: Genetic determinants that predispose to metastatic relapse of specific molecular subtype of breast cancer
timeFrame: at the end of enrollment (2 years)
measure: Overall survival
timeFrame: At the end of the study (7 years: 2 years of enrollment and 5 years of follow-up)
measure: Progression free survival
timeFrame: At the end of the study (7 years: 2 years of enrollment and 5 years of follow-up)
Other outcomes:
Locations:
city: BESANCON Cedex
country: France
facility: Hôpital Jean Minjoz - CHU Besançon
city: Bordeaux
country: France
facility: Institut Bergonié
city: Caen
country: France
facility: Centre François Baclesse
city: DIJON Cedex
country: France
facility: Centre Georges François Leclerc
city: Grenoble
country: France
facility: Institut Daniel Hollard
city: LIMOGES Cedex
country: France
facility: Hôpital Dupuytren
city: LYON Cedex 08
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Montpellier
country: France
facility: Val d'Aurelle
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: PARIS Cedex 05
country: France
facility: Institut Curie
city: Reims
country: France
facility: Institut Jean Godinot
city: SAINT HERBLAIN Cedex
country: France
facility: Centre René Gauducheau
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: TOULOUSE Cedex
country: France
facility: Institut Claudius Regaud
city: Vandoeuvre les Nancy
country: France
facility: Centre Alexis Vautrin
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Centre Leon Berard
name: Thomas BACHELOT, MD
role: PRINCIPAL_INVESTIGATOR
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