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)
← catalyst calendarNCT06926868 · readout in 572 d
Sponsored by Bristol-Myers Squibb (industry) · BMY — their whole pipeline →. With SystImmune Inc..
Phase
Phase 2/3
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
600estimated
Sites
295
Countries
Argentina, Australia, Austria +25
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-09-11 | actual | When the study began enrolling |
| Primary completion | 2028-03-13 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2030-05-15 | estimated | The whole study's end, after follow-up |
| First posted | 2025-04-15 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-10 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Breast Neoplasms
Interventions
- Drug: Iza-bren — also filed as BMS-986507, BL-B01D1, Izalontamab brengitecan
- Drug: Nab-paclitaxel
- Drug: Paclitaxel
- Drug: Capecitabine
- Drug: Carboplatin
- Drug: Gemcitabine
Primary outcomes
what the primary-completion date above is the date OFProgression-Free Survival (PFS)
measured Approximately 22 months from first participant randomization in Phase 3
Recommended Phase 3 Dose (RP3D) of BMS-986507
measured Approximately 13 months from first participant randomization in Phase 2
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