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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorCentre Paul Strauss

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

Qualifiers

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 design

Treatments tested in this trial

  • Blood sample for genetic analysis

Treatment groups

9,000 Participants
are divided into 5 treatment groups

Locations

1
Institut de cancérologie Strasbourg Europe67033, Strasbourg France

Sponsors and collaborators

Centre Paul Strauss

Lead sponsor