HER2-positive Breast CancerSIGHERNCT04638725
Identification of Genetic Determinants for Treatment Resistance/Sensitivity and/or Toxicity in Adjuvant Setting for HER2 Positive Breast Cancer
An observational study of HER2-positive Breast Cancer, run by Centre Paul Strauss at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- Blood sample for genetic analysis
- How many people
- 9,000 participants
- Where
- 1 siteFrance
- Study dates
- 15 Dec 2021to 15 Dec 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: HER2-positive Breast Cancer
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut de cancérologie Strasbourg Europe
Strasbourg, 67033
Valérie SARTORI, 368767223 ext. +33, v.sartori@icans.eu
Claire VIT, 388258529 ext. +33, promotion-rc@icans.eu
About this study
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.
Read the 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
- Being tested
- Blood sample for genetic analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample for genetic analysisOther
Blood samples will be collected in two 6 ml EDTA tubes after informed consent and inclusion in the study
| Study group | Role | What they receive |
|---|---|---|
| HER2 positive breast cancer treated only with trastuzumab | Not described Receives: Other: Blood sample for genetic analysis | |
| HER2 positive breast cancer treated with pertuzumab | Not described Receives: Other: Blood sample for genetic analysis | |
| HER2 positive breast cancer treated with neratinib | Not described Receives: Other: Blood sample for genetic analysis | |
| HER2 positive breast cancer treated with Trastuzumab emtansine (TDM1) | Not described Receives: Other: Blood sample for genetic analysis | |
| HER2 positive breast cancer treated with TDM1 and neratinib | Not described Receives: Other: Blood sample for genetic analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response (pCR)
Constitutional genetic variants using a genome-wide approach will be tested for association with pCR as a function of neoadjuvant treatment targeting HER2.
Measured: at the end of enrollment (3 years)
Disease Free Survival (DFS)
Constitutional genetic variants using a genome-wide approach will be tested for association with DFS as a function of treatment
Measured: At the end of the study (8 years)
Overall Survival (OS)
Constitutional genetic variants using a genome-wide approach will be tested for association with OS as a function of treatment
Measured: At the end of the study (8 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start15 Dec 2021
- Primary completion15 Dec 2033 (estimated)
- Study completion15 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Paul Strauss
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638725
- Sponsor's protocol ID
- 2020-010
- Acronym
- SIGHER
- Status last verified
- Jun 2026
- First submitted
- 9 Nov 2020
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Genetic Determinants for Treatment Resistance/Sensitivity and/or Toxicity in Adjuvant Setting for HER2 Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT04638725
- Acronym / sponsor ID
- SIGHER / 2020-010
- Conditions
- HER2-positive Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 9,000 participants (estimated)
- Lead sponsor
- Centre Paul StraussUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 15 Dec 2033 (estimated)
- Study completion
- 15 Dec 2033 (estimated)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| HER2 positive breast cancer treated only with trastuzumab | – | Other: Blood sample for genetic analysis |
| HER2 positive breast cancer treated with pertuzumab | – | Other: Blood sample for genetic analysis |
| HER2 positive breast cancer treated with neratinib | – | Other: Blood sample for genetic analysis |
| HER2 positive breast cancer treated with Trastuzumab emtansine (TDM1) | – | Other: Blood sample for genetic analysis |
| HER2 positive breast cancer treated with TDM1 and neratinib | – | Other: Blood sample for genetic analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HER2-positive Breast Cancer
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample for genetic analysisBlood samples will be collected in two 6 ml EDTA tubes after informed consent and inclusion in the study | Other | HER2 positive breast cancer treated only with trastuzumab, HER2 positive breast cancer treated with TDM1 and neratinib, HER2 positive breast cancer treated with Trastuzumab emtansine (TDM1), HER2 positive breast cancer treated with neratinib, HER2 positive breast cancer treated with pertuzumab |
Primary outcome
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.
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HER2-positive Breast Cancer, run by Centre Paul Strauss at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valérie SARTORI (368767223 ext. 33, v.sartori@icans.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Complete Response (pCR) (time frame: at the end of enrollment (3 years)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.