RECRUITING

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)

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Conditions

Breast Neoplasmstriple-negative breast cancerantibody-drug conjugate

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized, Open-label, Inferentially Seamless 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

Quick Facts

Study Start:2025-07-15
Study Completion:2030-05-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06926868

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically or cytologically confirmed and documented locally-advanced, recurrent inoperable, or metastatic TNBC (ER \< 1%, PgR \< 1%, HER2 IHC 0, 1+, or 2+ with FISH 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 FISH negative for HER2 gene amplification) per ASCO/CAP criteria, based on the most recently analyzed biopsy or other pathology specimen.
  2. * Patients with recurrent disease must have experienced disease relapse at least 6 months after finishing their last therapy with curative intent.
  3. * Patients with TNBC must be considered ineligible for 1L chemotherapy combination treatment with an anti-PD-1 or an anti-PD-L1 due to either one of the following criteria:.
  4. * Investigator-determined ineligibility based on PD-L1 negative disease determined and documented prior to trial screening as part of SoC.
  5. * Has experienced disease relapse between 6 to 12 months after the completion of (neo)adjuvant therapy with an anti-PD(L)1.
  6. * Has a severe auto-immune disease or other contraindication.
  7. * Patients with ER-low, HER2-negative BC must be ineligible, in the opinion of the Investigator, for endocrine therapy-based treatments.
  8. * No previous systemic therapy in the locally advanced, recurrent inoperable or metastatic setting (ie incurable setting).
  9. * Measurable disease by CT or MRI as per RECIST v1.1.
  10. * Other protocol-defined Inclusion/Exclusion criteria apply.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

BMS Study Connect Contact Center www.BMSStudyConnect.com
CONTACT
855-907-3286
Clinical.Trials@bms.com
First line of the email MUST contain NCT # and Site #.
CONTACT

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 0303
Hot Springs, Arkansas, 71913
United States
Local Institution - 0307
Cerritos, California, 90703
United States
Local Institution - 0308
Cerritos, California, 90703
United States
Local Institution - 0309
Cerritos, California, 90703
United States
Local Institution - 0311
Long Beach, California, 90805
United States
Local Institution - 0290
Los Angeles, California, 90033
United States
Local Institution - 0283
Los Angeles, California, 90067
United States
Local Institution - 0328
Whittier, California, 90603
United States
Local Institution - 0289
Aurora, Colorado, 80045
United States
Local Institution - 0304
Newark, Delaware, 19713
United States
Local Institution - 0282
Miami, Florida, 33136
United States
Local Institution - 0296
Pembroke Pines, Florida, 33028
United States
Local Institution - 0294
Atlanta, Georgia, 30322
United States
Local Institution - 0278
Chicago, Illinois, 60612
United States
Local Institution - 0280
Chicago, Illinois, 60637
United States
Decatur Memorial Hospital
Decatur, Illinois, 62526
United States
Local Institution - 0324
O'Fallon, Illinois, 62269
United States
Local Institution - 0286
Covington, Louisiana, 70433
United States
Local Institution - 0288
Boston, Massachusetts, 02114
United States
Local Institution - 0287
Boston, Massachusetts, 02215
United States
Local Institution - 0313
Minneapolis, Minnesota, 55404
United States
Local Institution - 0284
Kansas City, Missouri, 64111
United States
Local Institution - 0312
New York, New York, 10016
United States
Local Institution - 0279
New York, New York, 10021
United States
Clinical Research Alliance
Westbury, New York, 11590
United States
Local Institution - 0285
White Plains, New York, 10601
United States
Local Institution - 0276
Durham, North Carolina, 27710
United States
Local Institution - 0316
Eugene, Oregon, 97401
United States
Local Institution - 0310
Philadelphia, Pennsylvania, 19104-5127
United States
Local Institution - 0281
Greenville, South Carolina, 29607
United States
Local Institution - 0315
Austin, Texas, 78705
United States
Local Institution - 0314
Houston, Texas, 77024-2843
United States
Local Institution - 0305
Tyler, Texas, 75702
United States
Local Institution - 0277
Midlothian, Virginia, 23114
United States
Local Institution - 0301
Roanoke, Virginia, 24014
United States
Local Institution - 0302
Winchester, Virginia, 22601
United States

Collaborators and Investigators

Sponsor: Bristol-Myers Squibb

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-15
Study Completion Date2030-05-15

Study Record Updates

Study Start Date2025-07-15
Study Completion Date2030-05-15

Terms related to this study

Keywords Provided by Researchers

  • triple-negative breast cancer
  • antibody-drug conjugate

Additional Relevant MeSH Terms

  • Breast Neoplasms