Evaluation of [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT for Predicting Pathological Complete Response After Neoadjuvant Chemotherapy in HER2 Positive Early Breast Cancer
Recruiting · NCT07593976 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
[68Ga]Ga-NOTA-anti-HER2-sdAb Positron Emission Tomography
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Centre Henri Becquerel - Rouen, France