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.
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
Pregnant or breastfeeding women
Patient not treated with curative intent
History of ipsilateral breast cancer treated by surgery and/or radiotherapy
Lobular histology
Single group
[68Ga]Ga-NOTA-anti-HER2-sdAb Positron Emission Tomography
Other interventionPatients will undergo an \[68Ga\]Ga-NOTA-anti-HER2-sdAb PET/CT before neoadjuvant chemotherapy and 15 days prior the scheduled surgery
Concordance 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).
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)
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).
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