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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
42
Patients will undergo an \[68Ga\]Ga-NOTA-anti-HER2-sdAb PET/CT before neoadjuvant chemotherapy and 15 days prior the scheduled surgery
Centre Henri Becquerel
Rouen, France
RECRUITINGConcordance rate between the response estimated by [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT and the invasive pathological complete response
The concordance rate is defined as the proportion of patients correctly classified by the post-therapeutic PET/CT compared to the gold standard histopathological assessment (ypT0/is ypN0).
Time frame: 2 weeks after surgery
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
The concordance rate is calculated as the proportion of correctly classified patients compared to the non-invasive pCR definition (ypT0 ypN0), in addition to the invasive definition (ypT0/is ypN0)
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
ΔSUV is defined as the relative change in SUVmax between the baseline and post-therapeutic \[68Ga\]Ga-NOTA-anti-HER2-sdAb PET/CT, compared according to invasive pathological complete response (ypT0/is ypN0).
Time frame: Two weeks after surgery
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