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)
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
Inclusion Criteria * Histologically or cytologically confirmed and documented locally-advanced, recurrent inoperable, or metastatic triple-negative breast cancer (TNBC) (ER \< 1%, PgR \< 1%, HER2 IHC 0, 1+, or 2+ with ISH negative for HER2 gene amplification) or ER-low, HER2-negative BC (ER and / or PgR 1% to 10%, HER2 IHC 0, 1+, or 2+ with ISH negative for HER2 gene amplification) per American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) criteria, based on the most recently analyzed biopsy or other pathology specimen. * Patients with recurrent disease must have experienced disease relapse at least 6 months after finishing their last therapy with curative intent. * Participants with TNBC must be considered ineligible for 1L chemotherapy combination treatment with an anti-PD-1 (eg, pembrolizumab) or an anti-PD-L1 (eg, atezolizumab) due to any one of the following criteria: i) Investigator-determined ineligibility based on PD-L1 negative disease determined and documented prior to trial screening as part of standard of care (SoC); ii) Has experienced disease relapse between 6 to 12 months after the completion of (neo)adjuvant therapy with an anti-PD(L)1; iii) Has a severe auto-immune disease or other contraindication, in the opinion of the investigator, for the use of an anti-PD(L)1 drug: iv) Any auto-immune disease that requires current immunosuppression (eg, methotrexate, cyclophosphamide, prednisone \> 10 mg/day). v) Prior auto-immune AE to peri-adjuvant ICI that required immunosuppression. vi) Current Graves' disease with ophthalmopathy or in need of radioiodine or in use of antithyroid medication. vii) Current or prior auto-immune diseases per below: A. Moderate to severe rheumatoid arthritis. B. Auto-immune hepatitis or cholangitis. C. Myasthenia gravis. D. Moderate-to-severe or poorly controlled inflammatory bowel disease. E. Multiple sclerosis. F. Lupus with kidney involvement or moderate to severe lupus. G. Auto-immune myocarditis. Note: if participant meets Inclusion Criteria 5b or 5c, unknown PDL1 results per local SOC are acceptable in these specific cases. * Patients with ER-low, HER2-negative BC must be ineligible, in the opinion of the Investigator, for endocrine therapy-based treatments. * No previous systemic therapy in the locally advanced, recurrent inoperable or metastatic setting (ie incurable setting). * Measurable disease by CT or MRI as per RECIST v1.1. Exclusion Criteria * Participants with a known germline breast cancer gene (BRCA) 1 or 2 mutation whose best 1L treatment option, in the opinion of the investigator, is a poli-ADP-ribose-polymerase inhibitors (PARPi). * Untreated symptomatic central nervous system (CNS) metastases. Participants are eligible if CNS metastases have been treated, and participants' neurological signs and symptoms have returned to baseline. In addition, participants must have been either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to randomization. Imaging performed within 28 days of randomization must document radiographic stability of CNS lesions and be performed after completion of any CNS directed therapy. * Leptomeningeal metastases. * Participants with history of severe heart disease including, but not limited to, any of the following: i) History of clinically significant heart disease (eg, cardiomyopathy, congestive heart failure with New York Heart Association functional classification II to IV, pericarditis, or significant pericardial effusion). ii) Myocardial infarction, uncontrolled angina, or stroke/transient ischemic attack within the past 6 months. iii) QTc (by Fridericia's formula) prolongation ≥ 450 msec for males and ≥ 470 msec for females, except for right bundle branch block. iv) Known LVEF \< 50%. * Prior therapy with iza-bren or any other ADC targeting EGFR and/or HER3 or containing a topoisomerase 1 inhibitor payload. * Other protocol-defined Inclusion/Exclusion criteria apply.
Study sites (46)
AR
- Local Institution - 0303 · Hot Springs, AR 71913Site 0303 · Study contactMore trials in Hot Springs
CA
- Helios Clinical Research · Cerritos, CA 90703Omkar Marathe, Site 0328 · Study contact · 562-693-4477More trials in Cerritos
- Local Institution - 0307 · Cerritos, CA 90703More trials in Cerritos
- Local Institution - 0308 · Cerritos, CA 90703More trials in Cerritos
- Local Institution - 0309 · Cerritos, CA 90703More trials in Cerritos
- Local Institution - 0311 · Long Beach, CA 90805More trials in Long Beach
- USC/Norris Comprehensive Cancer Center · Los Angeles, CA 90033Daphne Stewart, Site 0290 · Study contact · 323-865-3906More trials in Los Angeles
- Valkyrie Clinical Trials · Los Angeles, CA 90067David Berz, Site 0283 · Study contact · 424-535-1874More trials in Los Angeles
- USC Norris Oncology/Hematology-Newport Beach · Newport Beach, CA 92663Daphne Stewart, Site 0353 · Study contact · 323-397-5954More trials in Newport Beach
- Local Institution - 0358 · Stanford, CA 94305Site 0358 · Study contactMore trials in Stanford
CO
- Local Institution - 0289 · Aurora, CO 80045Site 0289 · Study contactMore trials in Aurora
- Rocky Mountain Cancer Centers · Denver, CO 80220Mabel Mardones, Site 0367 · Study contactMore trials in Denver
DE
- Medical Oncology Hematology Consultants, PA · Newark, DE 19713Jamal Misleh, Site 0304 · Study contact · 302-366-1200More trials in Newark
FL
- Local Institution - 0296 · Pembroke Pines, FL 33028Site 0296 · Study contactMore trials in Pembroke Pines
GA
- Local Institution - 0294 · Atlanta, GA 30322More trials in Atlanta
- Northside Hospital · Atlanta, GA 30342Amelia Zelnak, Site 0357 · Study contact · 770-205-5292More trials in Atlanta
IL
- Local Institution - 0278 · Chicago, IL 60612More trials in Chicago
- Local Institution - 0280 · Chicago, IL 60637Site 0280 · Study contactMore trials in Chicago
- Decatur Memorial Hospital · Decatur, IL 62526James Wade, Site 0275 · Study contact · 217-876-6611More trials in Decatur
- Local Institution - 0324 · O'Fallon, IL 62269More trials in O'Fallon
LA
- Ochsner Clinic Foundation · Covington, LA 70433Melanie Sheen, Site 0286 · Study contact · 504-842-9780More trials in Covington
MA
- Massachusetts General Hospital · Boston, MA 02114Neelima Vidula, Site 0288 · Study contactMore trials in Boston
- Dana-Farber Cancer Institute · Boston, MA 02215Sara Tolaney, Site 0287 · Study contact · 617-632-5743More trials in Boston
MD
- Local Institution - 1035 · Baltimore, MD 21201Site 1035 · Study contactMore trials in Baltimore
MI
- Henry Ford Cancer- Detroit (Brigitte Harris Cancer Pavilion) · Detroit, MI 48202Rebecca Chacko, Site 0359 · Study contact · 313-530-1949More trials in Detroit
MN
- Minnesota Oncology Hematology · Maple Grove, MN 55369Eric Lander, Site 0313 · Study contactMore trials in Maple Grove
- Local Institution - 0372 · Minneapolis, MN 55455Site 0372 · Study contactMore trials in Minneapolis
MO
- Saint Luke's Cancer Institute · Kansas City, MO 64111Timothy Pluard, Site 0284 · Study contact · 314-747-7992More trials in Kansas City
NC
- Duke Cancer Institute · Durham, NC 27710Carey Anders, Site 0276 · Study contact · 919-684-0313More trials in Durham
NY
- Local Institution - 0312 · New York, NY 10016More trials in New York
- Memorial Sloan Kettering Cancer Center · New York, NY 10065Nour Abuhadra, Site 0279 · Study contact · 646-888-4451More trials in New York
- Local Institution - 1037 · Syracuse, NY 13210Site 1037 · Study contactMore trials in Syracuse
- Clinical Research Alliance · Westbury, NY 11590Jonathan Goldberg, Site 0295 · Study contact · 914-242-2991More trials in Westbury
- White Plains Hospital · White Plains, NY 10601Dan Costin, Site 0285 · Study contact · 914-849-7630More trials in White Plains
OR
- Willamette Valley Cancer Institute · Eugene, OR 97401Miho Dougherty, Site 0316 · Study contactMore trials in Eugene
PA
- Lehigh Valley Health Network · Allentown, PA 18103Nicholas Lamparella, Site 0356 · Study contact · 610-402-9543More trials in Allentown
- Abramson Cancer Center of The University of Pennsylvania · Philadelphia, PA 19104Payal Shah, Site 0310 · Study contactMore trials in Philadelphia
- Local Institution - 0360 · Pittsburgh, PA 15213-3403Site 0360 · Study contactMore trials in Pittsburgh
SC
- St Francis Cancer Center · Greenville, SC 29607Stephen Dyar, Site 0281 · Study contact · 864-603-6327More trials in Greenville
TX
- Texas Oncology - Central/South Texas · Austin, TX 78705Alvaro Restrepo, Site 0315 · Study contactMore trials in Austin
- Texas Oncology - West Texas · El Paso, TX 79902Ines Sanchez-Rivera, Site 0368 · Study contact · 915-544-6750More trials in El Paso
- Texas Oncology - Northeast Texas · Flower Mound, TX 75028Vibha Thomas, Site 0305 · Study contact · 303-925-0700More trials in Flower Mound
- (USOR) Texas Oncology · Houston, TX 77024-2843Dhatri Kodali, Site 0314 · Study contact · 555-555-5555More trials in Houston
VA
- Bon Secours St. Francis Medical Center · Midlothian, VA 23114William Irvin, Site 0277 · Study contactMore trials in Midlothian
- Local Institution - 0301 · Roanoke, VA 24014Site 0301 · Study contactMore trials in Roanoke
- Shenandoah Oncology, P.C. · Winchester, VA 22601William Houck, Site 0302 · Study contact · 540-662-1108More trials in Winchester