Evaluation of [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT for Predicting Pathological Complete Response After Neoadjuvant Chemotherapy in HER2 Positive Early Breast Cancer
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: [68Ga]Ga-NOTA-anti-HER2-sdAb Positron Emission Tomography.
- Кому может быть актуально
- Состояния в реестре: Breast Cancer. Базовые параметры: от 18 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Evaluation of [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT for Predicting Pathological Complete Response After Neoadjuvant Chemotherapy in HER2 Positive Early Breast Cancer (GATHER): a Study Protocol for a Monocentric, Prospective, Interventional, Phase 2, Imaging Biomarker Trial.
Обзор
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.
Подробное описание
In early-stage HER2-positive breast cancer, neoadjuvant chemotherapy is frequently required, and pathological complete response (pCR) correlates with excellent prognosis. However, no non-invasive imaging method reliably predicts pCR, making surgery mandatory despite its aesthetic, functional, and psychological burden. Recently, new functional imaging tracers targeting the HER2 protein have been developed. Among these, \[68Ga\]Ga-NOTA-anti-HER2-sdAb is of particular interest due to its molecular characteristic; it has demonstrated favorable safety profile and ability to identify HER2+ cells in vivo. This trial evaluates its ability to predict pCR, with the prospect of paving the way for future therapeutic de escalation and surgical sparing.
Вмешательства
- Другое [68Ga]Ga-NOTA-anti-HER2-sdAb Positron Emission Tomography
Patients will undergo an \[68Ga\]Ga-NOTA-anti-HER2-sdAb PET/CT before neoadjuvant chemotherapy and 15 days prior the scheduled surgery
Первичные конечные точки
- Concordance rate between the response estimated by [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT and the invasive pathological complete response [Срок оценки: 2 weeks after surgery]
Вторичные конечные точки (2)
- Concordance rate between the response estimated by [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT and the pCR on both invasive and non-invasive components [Срок оценки: two weeks after surgery]
- Comparison of the diagnostic performance of [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT against other conventional imaging modalities in predicting the invasive pCR [Срок оценки: Two weeks after surgery]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Диагностика
Центры проведения
Франция · 1 центр
- Centre Henri Becquerel — Rouen
Идентификаторы
NCT: NCT07593976 · CHB25.04 · 2025-523286-23-00