Evaluation of [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT for Predicting Pathological Complete Response After Neoadjuvant Chemotherapy in HER2 Positive Early Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: [68Ga]Ga-NOTA-anti-HER2-sdAb Positron Emission Tomography.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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.
Overview
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.
Detailed description
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.
Interventions
- Other [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
Primary outcome measures
- Concordance rate between the response estimated by [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT and the invasive pathological complete response [Time frame: 2 weeks after surgery]
Secondary outcome measures (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 [Time frame: 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 [Time frame: Two weeks after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- Centre Henri Becquerel — Rouen
Identifiers
NCT: NCT07593976 · CHB25.04 · 2025-523286-23-00