Identification of Genetic Determinants for Treatment Resistance/Sensitivity and/or Toxicity in Adjuvant Setting for HER2 Positive Breast Cancer
Recruiting · NCT04638725 · Observational (researchers observe without assigning treatment) · Lead sponsor: Centre Paul Strauss
View the official record on ClinicalTrials.gov →Interventions studied
Blood sample for genetic analysis
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
1 location listed.
- Institut de cancérologie Strasbourg Europe - Strasbourg, France