Informations générales (source: ClinicalTrials.gov)
Identification of Genetic Determinants for Treatment Resistance/Sensitivity and/or Toxicity in Adjuvant Setting for HER2 Positive Breast Cancer (SIGHER)
Observational
Institut de cancérologie Strasbourg Europe (Voir sur ClinicalTrials)
décembre 2021
décembre 2029
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL NOVO | NGUEFACK Rolande | 14/02/2025 09:03:20 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Institut de cancérologie Strasbourg Europe - 67033 - Strasbourg - France | Valérie SARTORI | Contact (sur clinicalTrials) | |||
Critères
Femme
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.
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.