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

Condition(s) studied

Investigational drug(s) / intervention(s)

Blood sample for genetic analysis: Blood samples will be collected in two 6 ml EDTA tubes after informed consent and inclusion in the study

Study summary

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

Primary outcome measure(s)

• Pathologic Complete Response (pCR) — at the end of enrollment (3 years)
  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) — At the end of the study (8 years)
  Constitutional genetic variants using a genome-wide approach will be tested for association with DFS as a function of treatment
• Overall Survival (OS) — At the end of the study (8 years)
  Constitutional genetic variants using a genome-wide approach will be tested for association with OS as a function of treatment

Trial sites (1)

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