Identification of Genetic Determinants for Treatment Resistance/Sensitivity and/or Toxicity in Adjuvant Setting for HER2 Positive Breast Cancer

Summary

Participation Requirements

Description

The purpose of the SIGHER trial is to create a cohort of 9000 patients with HER2-positive breast cancer including detailed epidemiologic and treatment data. The distribution of constitutional genetic variants will be evaluated within groups of patients treated with different regimes of targeted ther...

The purpose of the SIGHER trial is to create a cohort of 9000 patients with HER2-positive breast cancer including detailed epidemiologic and treatment data. The distribution of constitutional genetic variants will be evaluated within groups of patients treated with different regimes of targeted therapies, identifying variants associated with histological response, as well as sensitivity or resistance to these therapies. Blood samples will be collected in two 6ml ethylenediaminetetraacetic acid (EDTA) tubes after informed consent and inclusion in the 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.

Tracking Information