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

June 3, 2026 updated by: Centre Paul Strauss
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

9000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Strasbourg, France, 67033
        • Recruiting
        • Institut de cancérologie Strasbourg Europe
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

HER2-positive Breast Cancer

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HER2 positive breast cancer treated only with trastuzumab
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
HER2 positive breast cancer treated with pertuzumab
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
HER2 positive breast cancer treated with neratinib
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
HER2 positive breast cancer treated with Trastuzumab emtansine (TDM1)
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
HER2 positive breast cancer treated with TDM1 and neratinib
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathologic Complete Response (pCR)
Time Frame: at the end of enrollment (3 years)
Constitutional genetic variants using a genome-wide approach will be tested for association with pCR as a function of neoadjuvant treatment targeting HER2.
at the end of enrollment (3 years)
Disease Free Survival (DFS)
Time Frame: At the end of the study (8 years)
Constitutional genetic variants using a genome-wide approach will be tested for association with DFS as a function of treatment
At the end of the study (8 years)
Overall Survival (OS)
Time Frame: At the end of the study (8 years)
Constitutional genetic variants using a genome-wide approach will be tested for association with OS as a function of treatment
At the end of the study (8 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Paul Strauss

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2021

Primary Completion (Estimated)

December 15, 2033

Study Completion (Estimated)

December 15, 2033

Study Registration Dates

First Submitted

November 9, 2020

First Submitted That Met QC Criteria

November 16, 2020

First Posted (Actual)

November 20, 2020

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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