Interim FDG-PET/CT for PreDIcting REsponse of HER2+ Breast Cancer to Neoadjuvant Therapy: DIRECT Trial
Categories (click each to see list of all clinical trials associated with that category): Breast (ONC)
Current Status: Open
Phase: II (Cancer Control)
Principal Investigator: Krishnamurthy, Jairam
Eligibility: https://clinicaltrials.gov/study/NCT05710328?term=NCT05710328&rank=1
Summary
2.1 Primary Objective
2.1.1 To estimate the negative predictive value (NPV) of niFDG-PET/CT for pCR, using SULmaxD15, completed through central review, of the primary breast cancer at a threshold of 40%, in patients treated with neoadjuvant HER2-directed therapy.
2.2 Secondary Objectives
2.2.1 To estimate the sensitivity, specificity, and positive predictive value (PPV) of niFDG-PET/CT for pCR, using SULmaxD15 of the primary breast cancer at a threshold of 40%, in patients treated with neoadjuvant HER2-directed therapy.
2.2.2 To evaluate the performance of niFDG-PET/CT, using SULmaxD15 of the primary breast cancer at a threshold of 40%, as a predictor of 3-year event-free survival (EFS) from time of study registration.
2.3 Exploratory Objectives
2.3.1 To estimate the NPV of niFDG-PET/CT for pCR, using SULmaxD15 of the primary breast cancer at a grid of alternative thresholds ranging from 30% to 60%, in patients treated with neoadjuvant HER2-directed therapy.
2.3.2 To compare SULmaxD15 using automated image analysis of FDG-PET/CT by AutoPERCISTTM to standard PET analysis software.