Testing the Role of FDG-PET/CT to Predict Response to Therapy Prior to Surgery for HER2-positive Breast Cancer, The DIRECT Trial (NCT05710328)
Interim FDG-PET/CT for PreDIcting REsponse of HER2+ Breast Cancer to Neoadjuvant Therapy: DIRECT Trial
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (102 Sites)
Showing the first 25 of 102 sites.
- University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
- Cancer Center at Saint Joseph's — Phoenix, Arizona
- Los Angeles General Medical Center — Los Angeles, California
- USC / Norris Comprehensive Cancer Center — Los Angeles, California
- Saint John's Cancer Institute — Santa Monica, California
- Sibley Memorial Hospital — Washington D.C., District of Columbia
- Mayo Clinic in Florida — Jacksonville, Florida
- Hawaii Cancer Care Inc - Waterfront Plaza — Honolulu, Hawaii
- Queen's Cancer Cenrer - POB I — Honolulu, Hawaii
- Queen's Medical Center — Honolulu, Hawaii
- University of Hawaii Cancer Center — Honolulu, Hawaii
- Queen's Cancer Center - Kuakini — Honolulu, Hawaii
- Kapiolani Medical Center for Women and Children — Honolulu, Hawaii
- Castle Medical Center — Kailua, Hawaii
- Wilcox Memorial Hospital and Kauai Medical Clinic — Lihue, Hawaii
- Hawaii Cancer Care - Westridge — ‘Aiea, Hawaii
- Saint Luke's Cancer Institute - Twin Falls — Twin Falls, Idaho
- Northwestern University — Chicago, Illinois
- Carle at The Riverfront — Danville, Illinois
- Northwestern Medicine Cancer Center Kishwaukee — DeKalb, Illinois
- Carle Physician Group-Effingham — Effingham, Illinois
- Northwestern Medicine Cancer Center Delnor — Geneva, Illinois
- Northwestern Medicine Lake Forest Hospital — Lake Forest, Illinois
- Carle Physician Group-Mattoon/Charleston — Mattoon, Illinois
- Carle Cancer Center — Urbana, Illinois
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Anatomic Stage II Breast Cancer AJCC v8
- T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial — Birmingham, Alabama
- Intensity Modulated Radiation Therapy or 3-Dimensional Conformal Radiation Therapy in Treating Patients With Lymph-Node Positive Breast Cancer — Columbus, Ohio
- Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2 Positive Breast Cancer — Los Angeles, California
- CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy — Birmingham, Alabama
- An Optimized Ultrasound Twinkling Marker for the Imaging of Lymph Nodes in Patients With Clinically Node-Positive Breast Cancer, The UTMOST2 Trial — Rochester, Minnesota
Explore by condition: All Anatomic Stage II Breast Cancer AJCC v8 clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.