Identifying genetic factors affecting treatment response in HER2-positive breast cancer
Identification of Genetic Determinants for Treatment Resistance/Sensitivity and/or Toxicity in Adjuvant Setting for HER2 Positive Breast Cancer
Institut de cancérologie Strasbourg Europe · NCT04638725
This study is trying to find out how genetic differences affect how well people with HER2-positive breast cancer respond to treatment and if they experience side effects.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 9000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Institut de cancérologie Strasbourg Europe (other) |
| Drugs / interventions | trastuzumab, pertuzumab, neratinib, chemotherapy |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT04638725 on ClinicalTrials.gov |
What this trial studies
This multicenter, non-randomized, prospective cohort study aims to identify genetic determinants associated with treatment resistance, sensitivity, and toxicity in patients with HER2-positive breast cancer. A total of 9000 patients will be enrolled, and blood samples will be collected for genetic analysis after informed consent. The study will evaluate the distribution of genetic variants among patients treated with various targeted therapies and follow them for five years to assess treatment outcomes. The findings could enhance understanding of how genetic factors influence treatment responses in this patient population.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a histological diagnosis of operable, non-metastatic HER2-positive breast adenocarcinoma who have received or are receiving HER2-targeted therapy.
Not a fit: Patients with a history of cancer in the past five years or those unable to comply with the study protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized treatment strategies for patients with HER2-positive breast cancer, improving outcomes and minimizing toxicity.
How similar studies have performed: Other studies have explored genetic determinants in cancer treatment, but this specific approach focusing on HER2-positive breast cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
For inclusion in the study, patients must be affiliated to the national or local social security, and must meet all the following criteria: 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 this trial is running
Strasbourg
- Institut de cancérologie Strasbourg Europe — Strasbourg, France (RECRUITING)
Study contacts
- Study coordinator: Valérie SARTORI
- Email: v.sartori@icans.eu
- Phone: 368767223
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: HER2-positive Breast Cancer