RecruitingNCT04638725

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

Sponsor

Institut de cancérologie Strasbourg Europe

Enrollment

9,000 participants

Start Date

Dec 15, 2021

Study Type

OBSERVATIONAL

Conditions

HER2-positive Breast Cancer

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting genetic information from women with HER2-positive breast cancer who received HER2-targeted therapy (such as trastuzumab, pertuzumab, or T-DM1) to find out why some patients respond well and others develop resistance or serious side effects. The goal is to use genetics to personalize HER2-targeted treatment. **You may be eligible if...** - You are 18 or older - You have been diagnosed with HER2-positive breast cancer (non-metastatic) that was treatable with surgery - You received at least one HER2-targeted therapy (in the neoadjuvant or adjuvant setting) for your current breast cancer - Your adjuvant or neoadjuvant chemotherapy started after January 1, 2019 - You are affiliated with the French national or local social security system **You may NOT be eligible if...** - You have had another cancer in the 5 years before your HER2-targeted therapy - You are unable to comply with the study due to geographic, social, or psychological reasons - You are under judicial protection or guardianship Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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