A Study of Izalontamab Brengitecan Versus Chemotherapy in Participants With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer Ineligible for Anti-PD(L)1 Drugs (IZABRIGHT-Breast01) (NCT06926868)
IZABRIGHT-Breast01: A Randomized, Open-label, Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer (TNBC) or ER-low, HER2-negative BC Who Are Ineligible for Anti-PD1/PD-L1 Treatment
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to assess the efficacy and safety of iza-bren, a bi-specific antibody-drug conjugate against EGFR and HER3 with a topoisomerase inhibitor payload versus treatment of physician's choice (TPC) (paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, and capecitabine) for the treatment of first-line metastatic triple-negative breast cancer (TNBC) or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative BC patients who are not candidates for anti-PD(L)1 therapy and endocrine therapies.
Who can join: Review the eligibility criteria below.
Location: Local Institution - 0303 — Hot Springs, Arkansas
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 (295 Sites)
Showing the first 25 of 295 sites.
- Local Institution - 0303 — Hot Springs, Arkansas
- Helios Clinical Research — Cerritos, California
- Local Institution - 0307 — Cerritos, California
- Local Institution - 0308 — Cerritos, California
- Local Institution - 0309 — Cerritos, California
- Local Institution - 0311 — Long Beach, California
- USC/Norris Comprehensive Cancer Center — Los Angeles, California
- Valkyrie Clinical Trials — Los Angeles, California
- USC Norris Oncology/Hematology-Newport Beach — Newport Beach, California
- Local Institution - 0358 — Stanford, California
- Local Institution - 0289 — Aurora, Colorado
- Rocky Mountain Cancer Centers — Denver, Colorado
- Medical Oncology Hematology Consultants, PA — Newark, Delaware
- Local Institution - 0296 — Pembroke Pines, Florida
- Local Institution - 0294 — Atlanta, Georgia
- Northside Hospital — Atlanta, Georgia
- Local Institution - 0278 — Chicago, Illinois
- Local Institution - 0280 — Chicago, Illinois
- Decatur Memorial Hospital — Decatur, Illinois
- Local Institution - 0324 — O'Fallon, Illinois
- Ochsner Clinic Foundation — Covington, Louisiana
- Local Institution - 1035 — Baltimore, Maryland
- Massachusetts General Hospital — Boston, Massachusetts
- Dana-Farber Cancer Institute — Boston, Massachusetts
- Henry Ford Cancer- Detroit (Brigitte Harris Cancer Pavilion) — Detroit, Michigan
📞 Contact the Study Coordinator
Phone: (855) 907-3286
Email: Clinical.Trials@bms.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.