Clinical trial · Observational
Identification of Genetic Determinants for Treatment Resistance/Sensitivity and/or Toxicity in Adjuvant Setting for HER2 Positive Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample for genetic analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- label
- HER2 positive breast cancer treated only with trastuzumab
- interventionNames
- Other: Blood sample for genetic analysis
- label
- HER2 positive breast cancer treated with pertuzumab
- interventionNames
- Other: Blood sample for genetic analysis
- label
- HER2 positive breast cancer treated with neratinib
- interventionNames
- Other: Blood sample for genetic analysis
- label
- HER2 positive breast cancer treated with Trastuzumab emtansine (TDM1)
- interventionNames
- Other: Blood sample for genetic analysis
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available