Know Cancer

forgot password

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

18 Years
Open (Enrolling)
Breast Cancer, Metastasis

Thank you

Trial Information

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

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 1000 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

Inclusion Criteria:

- Women with a histologically proven breast cancer, 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

Type of Study:


Study Design:


Outcome Measure:

Germ line genetic factors associated with metastatic relapse

Outcome Description:

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)

Outcome Time Frame:

at the end of enrollment (2 years)

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Léon Bérard


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

December 2011

Completion Date:

December 2023

Related Keywords:

  • Breast Cancer
  • Metastasis
  • Germ line polymorphisms
  • Breast Neoplasms
  • Neoplasm Metastasis