Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05710328 · ClinicalTrials.gov registry record · Phase 2
Testing the Role of FDG-PET/CT to Predict Response to Therapy Prior to Surgery for HER2-positive Breast Cancer, The DIRECT Trial
A Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, sponsored by ECOG-ACRIN Cancer Research Group.
- Active
- Registry status
- Phase 2
- Development phase
- 235
- Enrollment target
- 20
- Study locations
NCT05710328: Active Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, sponsored by ECOG-ACRIN Cancer Research Group.
NCT05710328 is a Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8 that is active but no longer recruiting, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 235 participants, below the 302-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (22% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05710328, a Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, is active but no longer recruiting, sponsored by ECOG-ACRIN Cancer Research Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 235 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
The analysis set for this objective will comprise all patients who enrolled in the study and had a FDG-PET/CT scan at T0 and T1 timepoint. The negative predictive value is defined as the probability that pCR will not be achieved by study participants who experience a using delta maximum standardized uptake value corrected for lean body mass day 15 (deltaSULmaxD15) below 40% and will be estimated via an exact, two-sided 95% confidence interval.
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Positron Emission Tomography
- OTHER Fludeoxyglucose F-18
- DRUG Chemotherapy
- PROCEDURE Surgical Procedure
Study Locations (20)
Hawaii
- Hawaii Cancer Care Inc - Waterfront Plaza - Honolulu
- Queen's Cancer Cenrer - POB I - Honolulu
- Queen's Medical Center - Honolulu
- University of Hawaii Cancer Center - Honolulu
- Queen's Cancer Center - Kuakini - Honolulu
- Kapiolani Medical Center for Women and Children - Honolulu
- Castle Medical Center - Kailua
- Wilcox Memorial Hospital and Kauai Medical Clinic - Lihue
- Hawaii Cancer Care - Westridge - ‘Aiea
California
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- Saint John's Cancer Institute - Santa Monica
Illinois
- Northwestern University - Chicago
- Carle at The Riverfront - Danville
- Northwestern Medicine Cancer Center Kishwaukee - DeKalb
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Arizona
- Cancer Center at Saint Joseph's - Phoenix
District of Columbia
- Sibley Memorial Hospital - Washington D.C.
Florida
- Mayo Clinic in Florida - Jacksonville
Idaho
- Saint Luke's Cancer Institute - Twin Falls - Twin Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 235 participants |
| Start Date | 2023-05-10 |
| Est. Completion | 2029-12-31 |
| Phase | Phase 2 |
What the registry record for NCT05710328 still lists
NCT05710328 is an interventional study that assigns participants to a tested intervention. The registered 235 participants enrollment target is mid-sized for trials with a published cap, below the 302-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (22% lower).
The record links to 4 conditions, with Anatomic Stage III Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Computed Tomography is the first listed.
NCT05710328 names 20 study sites across 8 states, led by Hawaii, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT05710328 about?
NCT05710328 is a clinical study titled "Testing the Role of FDG-PET/CT to Predict Response to Therapy Prior to Surgery for HER2-positive Breast Cancer, The DIRECT Trial". 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 rad...
What is the current status of trial NCT05710328?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 235 participants. The study started on 2023-05-10. Estimated completion is 2029-12-31.
What conditions does trial NCT05710328 study?
This clinical trial studies the following conditions: Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Invasive Breast Carcinoma, HER2-Positive Breast Carcinoma.
What interventions are being tested in trial NCT05710328?
The interventions under investigation include: Computed Tomography (PROCEDURE), Positron Emission Tomography (PROCEDURE), Fludeoxyglucose F-18 (OTHER), Chemotherapy (DRUG), Surgical Procedure (PROCEDURE).
Who is sponsoring clinical trial NCT05710328?
This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05710328 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Anatomic Stage III Breast Cancer AJCC v8
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05710328's enrollment target sits among peer trials
235 22nd of 84 higher than 63 of 84 other Anatomic Stage III Breast Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anatomic Stage III Breast Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Hypofractionated Radiotherapy Before or After Breast Surgery for Treatment of Patients With Non-Metastatic Breast Cancer
RECRUITING · Phase 2
-
Ultra-hypofractionated Whole Breast Irradiation With Lumpectomy Cavity Boost for the Treatment of Stage I-III Breast Cancer
RECRUITING · Phase 2
-
Fisetin to Improve Physical Function in Stage I-III Breast Cancer Survivors
RECRUITING · Phase 2
-
Tamoxifen and Pegylated Liposomal Doxorubicin for the Treatment of Patients With Metastatic or Inoperable, Locally Advanced Triple Negative Breast Cancer
RECRUITING · Phase 2
-
Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer
RECRUITING · Phase 2
-
Prevention of Frailty With Fisetin and Exercise in Breast Cancer Survivors
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01524211 · 235 participants · NA
Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms
- NCT05316155 · 235 participants · Phase 1
Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer
- NCT05353569 · 235 participants · NA
Coherent Optical Detection of Middle Ear Disease
- NCT05390918 · 235 participants · NA
Targeting Adolescent Insomnia to Lessen Overall Risk of Suicidal Behavior
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI