About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial population
HER2-positive Breast Cancer
Trial design
Cohort
Prospective
Treatments tested in this trial
Blood sample for genetic analysis
Other interventionBlood samples will be collected in two 6 ml EDTA tubes after informed consent and inclusion in the study
Treatment groups
Trial outcomes
Primary outcomes
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.
Disease Free Survival (DFS)
Constitutional genetic variants using a genome-wide approach will be tested for association with DFS as a function of treatment
Overall Survival (OS)
Constitutional genetic variants using a genome-wide approach will be tested for association with OS as a function of treatment
Sponsors and contacts
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