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)

ClinicalTrials.gov ID: NCT06926868

Public ClinicalTrials.gov record NCT06926868. 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.

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ClinicalTrials.gov public records Last synced Sep 4, 2026, 12:56 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT06926868
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2, Phase 3
Lead sponsor: Bristol-Myers Squibb; Industry
Enrollment: 600 participants

Conditions and interventions

Conditions

Breast Neoplasms

Interventions

Drug

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: Sep 10, 2025
Primary completion: Mar 12, 2028
Completion: May 14, 2030
Last update posted: Aug 9, 2026

2025 – 2030

United States locations

U.S. sites: 46
U.S. states: 20
U.S. cities: 38

Facility	City	State	ZIP	Site status
Local Institution - 0303	Hot Springs	Arkansas	71913	Not yet recruiting
Helios Clinical Research	Cerritos	California	90703	Recruiting
Local Institution - 0307	Cerritos	California	90703	Withdrawn
Local Institution - 0308	Cerritos	California	90703	Withdrawn
Local Institution - 0309	Cerritos	California	90703	Withdrawn
Local Institution - 0311	Long Beach	California	90805	Withdrawn
USC/Norris Comprehensive Cancer Center	Los Angeles	California	90033	Recruiting
Valkyrie Clinical Trials	Los Angeles	California	90067	Recruiting
USC Norris Oncology/Hematology-Newport Beach	Newport Beach	California	92663	Recruiting
Local Institution - 0358	Stanford	California	94305	Not yet recruiting
Local Institution - 0289	Aurora	Colorado	80045	Not yet recruiting
Rocky Mountain Cancer Centers	Denver	Colorado	80220	Recruiting
Medical Oncology Hematology Consultants, PA	Newark	Delaware	19713	Recruiting
Local Institution - 0296	Pembroke Pines	Florida	33028	Not yet recruiting
Local Institution - 0294	Atlanta	Georgia	30322	Completed
Northside Hospital	Atlanta	Georgia	30342	Recruiting
Local Institution - 0278	Chicago	Illinois	60612	Withdrawn
Local Institution - 0280	Chicago	Illinois	60637	Not yet recruiting
Decatur Memorial Hospital	Decatur	Illinois	62526	Recruiting
Local Institution - 0324	O'Fallon	Illinois	62269	Withdrawn
Ochsner Clinic Foundation	Covington	Louisiana	70433	Recruiting
Local Institution - 1035	Baltimore	Maryland	21201	Not yet recruiting
Massachusetts General Hospital	Boston	Massachusetts	02114	Recruiting
Dana-Farber Cancer Institute	Boston	Massachusetts	02215	Recruiting
Henry Ford Cancer- Detroit (Brigitte Harris Cancer Pavilion)	Detroit	Michigan	48202	Recruiting
Minnesota Oncology Hematology	Maple Grove	Minnesota	55369	Recruiting
Local Institution - 0372	Minneapolis	Minnesota	55455	Not yet recruiting
Saint Luke's Cancer Institute	Kansas City	Missouri	64111	Recruiting
Local Institution - 0312	New York	New York	10016	Withdrawn
Memorial Sloan Kettering Cancer Center	New York	New York	10065	Recruiting
Local Institution - 1037	Syracuse	New York	13210	Not yet recruiting
Clinical Research Alliance	Westbury	New York	11590	Recruiting
White Plains Hospital	White Plains	New York	10601	Recruiting
Duke Cancer Institute	Durham	North Carolina	27710	Recruiting
Willamette Valley Cancer Institute	Eugene	Oregon	97401	Recruiting
Lehigh Valley Health Network	Allentown	Pennsylvania	18103	Recruiting
Abramson Cancer Center of The University of Pennsylvania	Philadelphia	Pennsylvania	19104	Recruiting
Local Institution - 0360	Pittsburgh	Pennsylvania	15213-3403	Not yet recruiting
St Francis Cancer Center	Greenville	South Carolina	29607	Recruiting
Texas Oncology - Central/South Texas	Austin	Texas	78705	Recruiting
Texas Oncology - West Texas	El Paso	Texas	79902	Recruiting
Texas Oncology - Northeast Texas	Flower Mound	Texas	75028	Recruiting
(USOR) Texas Oncology	Houston	Texas	77024-2843	Recruiting
Bon Secours St. Francis Medical Center	Midlothian	Virginia	23114	Recruiting
Local Institution - 0301	Roanoke	Virginia	24014	Not yet recruiting
Shenandoah Oncology, P.C.	Winchester	Virginia	22601	Recruiting

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 249 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06926868, 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 Aug 9, 2026 · Synced Sep 4, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06926868 live on ClinicalTrials.gov.

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