Identification of Genetic Determinants for Treatment Resistance/Sensitivity and/or Toxicity in Adjuvant Setting for HER2 Positive Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood sample for genetic analysis.
- Who it may be relevant to
- Registry conditions: HER2-positive Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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
Primary outcome measures
- Pathologic Complete Response (pCR) [Time frame: at the end of enrollment (3 years)]
- Disease Free Survival (DFS) [Time frame: At the end of the study (8 years)]
- Overall Survival (OS) [Time frame: At the end of the study (8 years)]
Eligibility criteria
For inclusion in the study, patients must be affiliated to the national or local social security, and must meet all the following criteria:
Inclusion criteria
- Age ≥ 18 years
- Histological diagnosis of breast adenocarcinoma. Non-metastatic and operable.
- Current or prior treatment with one therapy targeting HER2 in adjuvant or neoadjuvant phase for the current breast cancer
- Given written informed consent
Exclusion criteria
- Patients not able to comply to the protocol assessments for geographic, social or psychological reasons
- Patients placed under judicial protection, guardianship, or supervision
- History of cancer in the 5 years preceding anti-HER2 therapy initiation
- Concomitant cancer (except for an other non metastatic cancer treated only with surgery)
Note : Patients are eligible at any time of the follow-up if the adjuvant or neoadjuvant chemotherapy started after 01/01/2019. Patients treated with trastuzumab, pertuzumab, neratinib or T-DM1 in a clinical trial are eligible in the SIGHER study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Institut de cancérologie Strasbourg Europe — Strasbourg
Identifiers
NCT: NCT04638725 · 2020-010