Identifying genetic factors affecting treatment response in HER2-positive breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Institut de cancérologie Strasbourg Europe
  Strasbourg, France Recruiting

Study contacts

• Study coordinator: Valérie SARTORI
• Email: v.sartori@icans.eu
• Phone: 368767223

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Can we skip radiation after lumpectomy for low-risk HER2-positive breast cancer?

  This study tests whether patients who had breast-conserving surgery and low-risk HER2-positive breast cancer can safely skip radiation therapy while receiving HER2-targeted treatment.

  Recruiting at 7 sites Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07895511

• Breast cancer subtypes and outcomes in Colombian women

  This study looks back at medical records of women with breast cancer to see how different molecular subtypes relate to survival and recurrence in a single Colombian hospital.

  Recruiting Fundación Santa Fe de Bogota · Bogotá, Bogota D.C. · NCT07856225

• SMP-656 in HER2-positive advanced breast cancer after ADC therapy

  This trial tests whether SMP-656 given by IV every 3 weeks can help people with HER2-positive locally advanced or metastatic breast cancer who progressed after a HER2-targeted antibody-drug conjugate.

  Recruiting Phase 2 Chengdu SciMount Pharmatech Co., Ltd. · Hefei, Anhui and 14 other locations · NCT07726342

• Entinostat with Pyrotinib and Endocrine Therapy in HER2-positive, HR-positive Advanced Breast Cancer after Trastuzumab Failure

  This study tests whether adding entinostat to pyrotinib and hormone therapy is safe and helps patients with advanced HR+/HER2+ breast cancer who progressed after trastuzumab.

  Recruiting Phase 1/2 Tianjin Medical University Cancer Institute and Hospital · Tianjin, Tianjin Municipality · NCT07708194

• GQ1005 versus T-DM1 in HER2-positive unresectable or metastatic breast cancer

  This trial tests whether GQ1005 works as well as T-DM1 for adults with HER2-positive unresectable or metastatic breast cancer who have already had trastuzumab and taxane.

  Recruiting at 70 sites Phase 3 GeneQuantum Healthcare (Suzhou) Co., Ltd. · Bengbu, Anhui and 69 other locations · NCT07673029

• Trastuzumab Rezetecan Neoadjuvant Therapy for HER2-Positive Breast Cancer

  This trial tests whether adding trastuzumab rezetecan after an initial THP treatment helps patients with HER2-positive breast cancer decide if they should switch therapies based on response.

  Recruiting Phase 2 The First Affiliated Hospital of Soochow University · Suzhou, Jiangsu · NCT07647263

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.