Testing the Role of FDG-PET/CT to Predict Response to Therapy Prior to Surgery for HER2-positive Breast Cancer, The DIRECT Trial (NCT05710328)

🧪 Interventions in This Study

• Chemotherapy (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Patients (all genders) must be \>= 18 years of age.
2. Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible.
3. Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
4. Patient must have histologically confirmed HER2-positive primary invasive breast carcinoma by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines that has been determined by local testing.
5. Patient must have known (either positive or negative) hormone receptor (estrogen receptor \[ER\] or progesterone receptor \[PR\]) status by local testing, per ASCO/CAP guidelines. Patients with either hormone receptor-positive or hormone receptor- negative HER2-positive breast cancer are eligible.
6. Patient must have American Joint Committee on Cancer (AJCC) 8th Edition stage IIa-IIIc according to anatomic staging table at diagnosis and below criteria.
7. Patients without nodal involvement (cN0) are eligible if T size \> 2.0 cm (T2-4)
8. Patients with nodal involvement (cN1-3) are eligible if T2-4
9. Patients with clinical T4d are not eligible
10. Patients with bilateral invasive breast cancers are eligible if both cancers are HER2-positive and at least one meets all protocol eligibility criteria and neither cancer renders the patient ineligible.
11. Patients with multiple ipsilateral invasive tumors are eligible as long as all tumors are HER2-positive and at least one tumor focus meets all eligibility criteria. Multiple lesions that appear part of the same index tumor do not require additional biopsy/HER2 testing.
12. Patient must plan to start a standard neoadjuvant pertuzumab (or other biosimilars) based regimen.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 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
• An Optimized Ultrasound Twinkling Marker for the Imaging of Lymph Nodes in Patients With Clinically Node-Positive Breast Cancer, The UTMOST2 Trial — Rochester, Minnesota
• Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial — Jonesboro, Arkansas
• Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2 Positive Breast Cancer — Los Angeles, California

Explore by condition: All Anatomic Stage II Breast Cancer AJCC v8 clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.