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)
Sponsored by Bristol-Myers Squibb
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.
Where this study is enrolling (21)
- Call 323-397-5954
USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 562-693-4477
Helios Clinical Research
Cerritos, California
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 323-865-3906
USC/Norris Comprehensive Cancer Center
Los Angeles, California
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 424-535-1874
Valkyrie Clinical Trials
Los Angeles, California
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 302-366-1200
Medical Oncology Hematology Consultants, PA
Newark, Delaware
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
Show all 21 locations
- Call 770-205-5292
Northside Hospital
Atlanta, Georgia
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 217-876-6611
Decatur Memorial Hospital
Decatur, Illinois
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 504-842-9780
Ochsner Clinic Foundation
Covington, Louisiana
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 617-632-5743
Dana-Farber Cancer Institute
Boston, Massachusetts
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 313-530-1949
Henry Ford Cancer- Detroit (Brigitte Harris Cancer Pavilion)
Detroit, Michigan
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 314-747-7992
Saint Luke's Cancer Institute
Kansas City, Missouri
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 646-888-4451
Memorial Sloan Kettering Cancer Center
New York, New York
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 914-849-7630
White Plains Hospital
White Plains, New York
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 914-242-2991
Clinical Research Alliance
Westbury, New York
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 919-684-0313
Duke Cancer Institute
Durham, North Carolina
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 610-402-9543
Lehigh Valley Health Network
Allentown, Pennsylvania
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 864-603-6327
St Francis Cancer Center
Greenville, South Carolina
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 915-544-6750
Texas Oncology - West Texas
El Paso, Texas
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 832-932-1730
(USOR) Texas Oncology
Houston, Texas
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 303-925-0700
Texas Oncology - Northeast Texas
Flower Mound, Texas
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 540-662-1108
Shenandoah Oncology, P.C.
Winchester, Virginia
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
Who can participate
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.
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.