Prospective multicenter study evaluating the prediction of histological response after neoadjuvant pembrolizumab in combination with chemotherapy by pre-treatment 68Ga-FAPI-46 PET/CT imaging in patients with early-stage high-risk TNBC.
Female with age ≥ 18 years,
Patients with previously untreated, non-metastatic, centrally confirmed TNBC for whom a neoadjuvant treatment with chemotherapy + pembrolizumab is the recommended option as standard of care,
Patients with measurable targets according to RECIST/PERCIST criteria,
Patients without distant metastasis based on staging 18F-FDG PET/CT,
Pregnant and lactating women,
Patients with prior anti-PD(L)1 immunotherapy,
Patients with any contra-indication to chemo-immunotherapy standard of care therapy, per investigator assessment,
Patients with altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient informed consent,