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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05710328
The ClinicalTrials.gov registry entry for NCT05710328 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 235 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 302-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (22% lower). The listed sponsor is ECOG-ACRIN Cancer Research Group, which has 75 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 8 distinct geographic areas - top geographies include 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.
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