EA1211: interim FDG-PET/CT for predicting response of HER2-positive breast cancer to neoadjuvant therapy (DIRECT trial)

Le résumé fourni par la source

Recent studies indicate that early changes on 2-deoxy-2-[18F]fluoro-D-glucose Positron Emission Tomography/Computed Tomography (FDG-PET/CT) predict response to human epidermal growth factor receptor 2 (HER2)-directed therapy. EA1211/DIRECT is a multicenter, single-arm, primary imaging phase 2 study enrolling patients with stage II/III HER2-positive breast cancer receiving pertuzumab-based neoadjuvant therapy followed by surgery. The trial aims to validate FDG-PET/CT as a neoadjuvant interim (niFDG-PET/CT) imaging integral biomarker in patients treated with standard HER2-directed regimens. The primary objective is to estimate the negative predictive value of niFDG-PET/CT for pathologic complete response using delta maximum standardized uptake value corrected for lean body mass day 15 (ΔSULmaxD15) of the primary breast cancer at a threshold of 40%. If EA1211/DIRECT meets its objectives, the results will be used to design clinical utility studies for this noninvasive imaging biomarker, hoping to change practice toward a response-guided approach, ensuring patients receive treatment tailored to their tumor biology and individual response.Clinical trial registration NCT05710328.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.