Testing the Role of FDG-PET/CT to Predict Response to Therapy Prior to Surgery for HER2-positive Breast Cancer, The DIRECT Trial
Public ClinicalTrials.gov record NCT05710328. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Interim FDG-PET/CT for PreDIcting REsponse of HER2+ Breast Cancer to Neoadjuvant Therapy: DIRECT Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05710328
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 235 participants
Conditions and interventions
Conditions
Interventions
- Chemotherapy Drug
- Computed Tomography Procedure
- Fludeoxyglucose F-18 Other
- Positron Emission Tomography Procedure
- Surgical Procedure Procedure
Drug · Procedure · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 10, 2023 (Actual)
- Primary completion
- May 31, 2027 (Estimated)
- Completion
- Dec 31, 2029 (Estimated)
- Last update posted
- Oct 19, 2026
2023 – 2029
United States locations
- U.S. sites
- 97
- U.S. states
- 29
- U.S. cities
- 84
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | Birmingham | Alabama | 35233 | — |
| Cancer Center at Saint Joseph's | Phoenix | Arizona | 85004 | — |
| Los Angeles General Medical Center | Los Angeles | California | 90033 | — |
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| Saint John's Cancer Institute | Santa Monica | California | 90404 | — |
| Sibley Memorial Hospital | Washington D.C. | District of Columbia | 20016 | — |
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | — |
| Hawaii Cancer Care Inc - Waterfront Plaza | Honolulu | Hawaii | 96813 | — |
| Queen's Cancer Cenrer - POB I | Honolulu | Hawaii | 96813 | — |
| Queen's Medical Center | Honolulu | Hawaii | 96813 | — |
| University of Hawaii Cancer Center | Honolulu | Hawaii | 96813 | — |
| Queen's Cancer Center - Kuakini | Honolulu | Hawaii | 96817 | — |
| Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | 96826 | — |
| Castle Medical Center | Kailua | Hawaii | 96734 | — |
| Wilcox Memorial Hospital and Kauai Medical Clinic | Lihue | Hawaii | 96766 | — |
| Hawaii Cancer Care - Westridge | ‘Aiea | Hawaii | 96701 | — |
| Saint Luke's Cancer Institute - Twin Falls | Twin Falls | Idaho | 83301 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Carle at The Riverfront | Danville | Illinois | 61832 | — |
| Northwestern Medicine Cancer Center Kishwaukee | DeKalb | Illinois | 60115 | — |
| Carle Physician Group-Effingham | Effingham | Illinois | 62401 | — |
| Northwestern Medicine Cancer Center Delnor | Geneva | Illinois | 60134 | — |
| Northwestern Medicine Lake Forest Hospital | Lake Forest | Illinois | 60045 | — |
| Carle Physician Group-Mattoon/Charleston | Mattoon | Illinois | 61938 | — |
| Carle Cancer Center | Urbana | Illinois | 61801 | — |
| Northwestern Medicine Cancer Center Warrenville | Warrenville | Illinois | 60555 | — |
| The James Graham Brown Cancer Center at University of Louisville | Louisville | Kentucky | 40202 | — |
| Louisiana State University Health Science Center | New Orleans | Louisiana | 70112 | — |
| University Medical Center New Orleans | New Orleans | Louisiana | 70112 | — |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Minnesota Oncology - Burnsville | Burnsville | Minnesota | 55337 | — |
| Mercy Hospital | Coon Rapids | Minnesota | 55433 | — |
| Minnesota Oncology Hematology PA-Maplewood | Maplewood | Minnesota | 55109 | — |
| Abbott-Northwestern Hospital | Minneapolis | Minnesota | 55407 | — |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | — |
| Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota | 55416 | — |
| United Hospital | Saint Paul | Minnesota | 55102 | — |
| Minnesota Oncology Hematology PA-Woodbury | Woodbury | Minnesota | 55125 | — |
| Baptist Memorial Hospital and Cancer Center-Oxford | Oxford | Mississippi | 38655 | — |
| Baptist Memorial Hospital and Cancer Center-Desoto | Southhaven | Mississippi | 38671 | — |
| CoxHealth South Hospital | Springfield | Missouri | 65807 | — |
| Mercy Hospital South | St Louis | Missouri | 63128 | — |
| Nebraska Medicine-Bellevue | Bellevue | Nebraska | 68123 | — |
| Nebraska Medicine-Village Pointe | Omaha | Nebraska | 68118 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| Cooper Hospital University Medical Center | Camden | New Jersey | 08103 | — |
| Morristown Medical Center | Morristown | New Jersey | 07960 | — |
| Inspira Medical Center Mullica Hill | Mullica Hill | New Jersey | 08062 | — |
| Saint Joseph's Regional Medical Center | Paterson | New Jersey | 07503 | — |
| Inspira Medical Center Vineland | Vineland | New Jersey | 08360 | — |
| MD Anderson Cancer Center at Cooper-Voorhees | Voorhees Township | New Jersey | 08043 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| Montefiore Medical Center-Einstein Campus | The Bronx | New York | 10461 | — |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | — |
| Indu and Raj Soin Medical Center | Beavercreek | Ohio | 45431 | — |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | — |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| Kettering Medical Center | Kettering | Ohio | 45429 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Bryn Mawr Hospital | Bryn Mawr | Pennsylvania | 19010 | — |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | — |
| Riddle Memorial Hospital | Media | Pennsylvania | 19063 | — |
| Bryn Mawr Health Center | Newtown Square | Pennsylvania | 19073 | — |
| Paoli Memorial Hospital | Paoli | Pennsylvania | 19301 | — |
| Guthrie Medical Group PC-Robert Packer Hospital | Sayre | Pennsylvania | 18840 | — |
| Community Medical Center | Scranton | Pennsylvania | 18510 | — |
| Chester County Hospital | West Chester | Pennsylvania | 19380 | — |
| Geisinger Wyoming Valley/Henry Cancer Center | Wilkes-Barre | Pennsylvania | 18711 | — |
| Lankenau Medical Center | Wynnewood | Pennsylvania | 19096 | — |
| Baptist Memorial Hospital and Cancer Center-Collierville | Collierville | Tennessee | 38017 | — |
| Baptist Memorial Hospital and Cancer Center-Memphis | Memphis | Tennessee | 38120 | — |
| Dell Seton Medical Center at The University of Texas | Austin | Texas | 78701 | — |
| University of Texas at Austin | Austin | Texas | 78712 | — |
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | — |
| Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia | 23298 | — |
| FHCC South Lake Union | Seattle | Washington | 98109 | — |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | — |
| University of Washington Medical Center - Montlake | Seattle | Washington | 98195 | — |
| Aurora Cancer Care-Southern Lakes VLCC | Burlington | Wisconsin | 53105 | — |
| Marshfield Medical Center-EC Cancer Center | Eau Claire | Wisconsin | 54701 | — |
| Aurora Health Care Germantown Health Center | Germantown | Wisconsin | 53022 | — |
| Saint Vincent Hospital Cancer Center Green Bay | Green Bay | Wisconsin | 54301 | — |
| Saint Vincent Hospital Cancer Center at Saint Mary's | Green Bay | Wisconsin | 54303 | — |
| Marshfield Medical Center - Ladysmith | Ladysmith | Wisconsin | 54848 | — |
| University of Wisconsin Carbone Cancer Center - University Hospital | Madison | Wisconsin | 53792 | — |
| Marshfield Medical Center-Marshfield | Marshfield | Wisconsin | 54449 | — |
| Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin | 53215 | — |
| Aurora Sinai Medical Center | Milwaukee | Wisconsin | 53233 | — |
| Marshfield Clinic-Minocqua Center | Minocqua | Wisconsin | 54548 | — |
| Marshfield Medical Center - Neillsville | Neillsville | Wisconsin | 54456 | — |
| Marshfield Medical Center-Rice Lake | Rice Lake | Wisconsin | 54868 | — |
| Marshfield Medical Center-River Region at Stevens Point | Stevens Point | Wisconsin | 54482 | — |
| Aurora West Allis Medical Center | West Allis | Wisconsin | 53227 | — |
| Marshfield Medical Center - Weston | Weston | Wisconsin | 54476 | — |
| Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids | Wisconsin | 54494 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05710328, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 19, 2026 · Synced Oct 26, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05710328 live on ClinicalTrials.gov.