Recruiting
Evaluation of [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT for Predicting Pathological Complete Response After Neoadjuvant Chemotherapy in HER2 Positive Early Breast Cancer
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.
ClinicalTrials.gov IDNCT07593976
PhasePHASE2
Enrollment42
SponsorCentre Henri Becquerel
Age18 Years
SexFEMALE
Conditions studied
Breast Cancer
About this study
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.
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 outcomes
- Concordance rate between the response estimated by [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT and the invasive pathological complete response (2 weeks after surgery)
Eligibility information
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
Study locations
- Centre Henri Becquerel, Rouen, France
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.