OncoMatch/Clinical Trials/NCT06926868

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)

Is NCT06926868 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments for breast neoplasms.

Phase 2/3RecruitingBristol-Myers SquibbNCT06926868Data as of May 2026

Treatment: Iza-bren · Nab-paclitaxel · Paclitaxel · Capecitabine · Carboplatin · Gemcitabine — 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.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Biomarker criteria

Required: ESR1 expression < 1% (< 1%)

ER < 1%

Required: PR (PGR) expression < 1% (< 1%)

PgR < 1%

Required: HER2 (ERBB2) IHC 0, 1+, or 2+ with ISH negative for HER2 gene amplification (IHC 0, 1+, or 2+ with ISH negative)

HER2 IHC 0, 1+, or 2+ with ISH negative for HER2 gene amplification

Required: ESR1 expression 1% to 10% (1% to 10%)

ER and / or PgR 1% to 10%

Required: PR (PGR) expression 1% to 10% (1% to 10%)

ER and / or PgR 1% to 10%

Required: HER2 (ERBB2) IHC 0, 1+, or 2+ with ISH negative for HER2 gene amplification (IHC 0, 1+, or 2+ with ISH negative)

HER2 IHC 0, 1+, or 2+ with ISH negative for HER2 gene amplification

Prior therapy

No prior treatment (treatment-naive required)

Max 0 prior lines

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

Local Institution - 0303 · Hot Springs, Arkansas
Helios Clinical Research · Cerritos, California
Local Institution - 0307 · Cerritos, California
Local Institution - 0308 · Cerritos, California
Local Institution - 0309 · Cerritos, California

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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