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

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…

ClinicalTrials.gov IDNCT04638725

PhaseNot Applicable

Enrollment9000

SponsorCentre Paul Strauss

Age18 Years

SexFEMALE

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Conditions studied

HER2-positive Breast Cancer

About this study

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 outcomes

Pathologic Complete Response (pCR) (at the end of enrollment (3 years))
Disease Free Survival (DFS) (At the end of the study (8 years))
Overall Survival (OS) (At the end of the study (8 years))

Eligibility information

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 locations

Institut de cancérologie Strasbourg Europe, Strasbourg, 67033 France

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-29.