NCT04638725

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 9,000 (estimated)
• Sponsor: Institut de cancérologie Strasbourg Europe · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, non-randomized, prospective cohort study. The purpose of the study is to identify constitutional genetic factors associated with histological response, resistance or sensibility to treatment in human epidermal growth factor receptor 2 (HER2)-positive breast cancer. 9000 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 every six months for five years.

Detailed 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 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, total blood will be aliquoted into a 500 µl tube and frozen at -80° C. DNA will be extracted using standard protocols. 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.

Conditions

• HER2-positive Breast Cancer

Interventions

Type	Name	Description
OTHER	Blood sample for genetic analysis	Blood samples will be collected in two 6 ml EDTA tubes after informed consent and inclusion in the study

Timeline

• Start date: 2021-12-15
• Primary completion: 2029-12-15
• Completion: 2029-12-15
• First posted: 2020-11-20
• Last updated: 2022-08-03

Locations

1 site across 1 country: France