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.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
[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
干预措施: [68Ga]Ga-NOTA-anti-HER2-sdAb Positron Emission Tomography (Other)