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Breast NeoplasmsCancerDrugPhase 2, Phase 3

What this study is

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.

What's being tested

  • Iza-bren

    Intervention · DRUG

  • Nab-paclitaxel

    Intervention · DRUG

  • Paclitaxel

    Intervention · DRUG

  • Capecitabine

    Intervention · DRUG

  • Carboplatin

    Intervention · DRUG

  • Gemcitabine

    Intervention · DRUG

All interventions

Specified dose on specified days

Study details

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
Sponsor
Bristol-Myers Squibb
Conditions
Breast Neoplasms
Enrolling
600 people
Starts
2025-09-11
Est. completion
2030-05-15
Design
Open-label, randomized, parallel groups, Phase 2, Phase 3
Record
View on ClinicalTrials.gov ↗