Clinical Trial

Testing the Role of FDG-PET/CT to Predict Response to Therapy Prior to Surgery for HER2-positive Breast Cancer, The DIRECT Trial

Active, Not Recruiting Phase 2

Summary

This phase II trial tests how well an imaging procedure called fludeoxyglucose F-18 (FDG) positron emission tomography/computed tomography (PET/CT) works in predicting response to standard of care chemotherapy prior to surgery in patients with HER2-positive stage IIa-IIIc breast cancer. FDG is a radioactive tracer that is given in a vein before PET/CT imaging and helps to identify areas of active cancer. PET and CT are imaging techniques that make detailed, computerized pictures of areas inside the body. The use of FDG-PET/CT may help doctors better decide if a patient needs more or less treatment before surgery in order to get the best response. This study evaluates whether FDG-PET/CT is useful in predicting a patient's response to standard of care chemotherapy.

Protocol Amendment History 14 amendments

This ClinicalTrials.gov record has been amended 14 times since 2023-01-24; most recent amendment 2026-06-16.

Status change: Recruiting → Active, Not Recruiting 2026-01-26

Status change: Not Yet Recruiting → Recruiting 2023-05-15

Trial Details

NCT Number	NCT05710328
Lead Sponsor	ECOG-ACRIN Cancer Research Group
Conditions	Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, HER2-Positive Breast Carcinoma, Invasive Breast Carcinoma
Enrollment	235 participants
Start Date	2023-05-10
Primary Completion	2027-05-31 (estimated)
Study Completion	2029-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-18