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

NCT05710328 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 235

Last updated 2026-05-05

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Chemotherapy

Receive standard of care chemotherapy

PROCEDURE

Computed Tomography

Undergo PET/CT

OTHER

Fludeoxyglucose F-18

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

PROCEDURE

Surgical Procedure

Undergo standard of care surgery

Sponsors & Collaborators

  • ECOG-ACRIN Cancer Research Group

    lead NETWORK

Principal Investigators

  • Heather Jacene · ECOG-ACRIN Cancer Research Group

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-10
Primary Completion
2027-05-31
Completion
2029-12-31

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05710328 on ClinicalTrials.gov