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

> **NCT05710328** · PHASE2 · ACTIVE_NOT_RECRUITING · sponsor: **ECOG-ACRIN Cancer Research Group** · enrollment: 235 (estimated)

## Conditions studied

- Anatomic Stage II Breast Cancer AJCC v8
- Anatomic Stage III Breast Cancer AJCC v8
- HER2-Positive Breast Carcinoma
- Invasive Breast Carcinoma

## Interventions

- **DRUG:** Chemotherapy
- **PROCEDURE:** Computed Tomography
- **OTHER:** Fludeoxyglucose F-18
- **PROCEDURE:** Positron Emission Tomography
- **PROCEDURE:** Surgical Procedure

## Key facts

- **NCT ID:** NCT05710328
- **Lead sponsor:** ECOG-ACRIN Cancer Research Group
- **Sponsor class:** NETWORK
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2023-05-10
- **Primary completion:** 2027-05-31
- **Final completion:** 2029-12-31
- **Target enrollment:** 235 (ESTIMATED)
- **Last updated:** 2026-05-05


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05710328

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05710328, "Testing the Role of FDG-PET/CT to Predict Response to Therapy Prior to Surgery for HER2-positive Breast Cancer, The DIRECT Trial". Retrieved via AI Analytics 2026-06-23 from https://api.ai-analytics.org/clinical/NCT05710328. Licensed CC0.

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