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Evaluation of [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT for Predicting Pathological Complete Response After Neoadjuvant Chemotherapy in HER2 Positive Early Breast Cancer

RecruitingPhase 2Ages 18 Years - anyFemaleCentre Henri Becquerel
NCT07593976 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The GATHER trial aim to evaluate the diagnostic performance of \[68Ga\]Ga-NOTA-anti-HER2-sdAb PET/CT in predicting pCR following neoadjuvant chemotherapy. This study is part of the development of new functional, non-invasive approaches with the aim of offering personalized therapeutic approaches.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Female aged 18 years or older * Histologically proven HER2-positive early breast cancer, defined as IHC 3+ or IHC 2+ with ISH amplification * Indication for neoadjuvant chemotherapy combined with anti-HER2 targeted therapy followed by surgery, as determined by a multidisciplinary tumor board * ECOG performance status of 0 or 1 * Affiliated to or beneficiary of a social protection scheme * Written informed consent signed prior to any study-specific procedure Exclusion Criteria: * Pregnant or breastfeeding women * Patient not treated with curative intent * History of ipsilateral breast cancer treated by surgery and/or radiotherapy * Lobular histology * Known contraindication or hypersensitivity to \[68Ga\]Ga-NOTA-anti-HER2-sdAb or any of its radiopharmaceutical excipients * Known contraindication or hypersensitivity to \[18F\]F-FDG or any of its radiopharmaceutical excipients * Concurrent enrollment in another clinical trial evaluating radiopharmaceuticals * Patient under guardianship, curatorship, or judicial protection * Patient deprived of liberty * Inability to understand the study or comply with trial constraints due to linguistic, psychological, or geographical barriers
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What it tests

  • [68Ga]Ga-NOTA-anti-HER2-sdAb Positron Emission Tomography
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Where

1 site
Centre Henri Becquerel
Rouen, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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