IZABRIGHT-Breast01: 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

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-519871-24-00

Acronym

CA244-0008

Enrollment

159

Registered

2025-10-17

Start date

2025-11-11

Completion date

Unknown

Last updated

2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer, Triple-negative breast cancer

Brief summary

PFS (progression-free survival) by BICR (Blinded Independent Central Review) The ability of iza-bren to work better than other common treatments chosen by the doctors is tested by looking at the PFS, which shows how long it takes for the disease to get worse by radiographic imaging techniques (like CT scans).

Detailed description

This study will assess if people live longer when they take iza-bren compared to other treatments chosen by the doctors. This is what is called "Overall Survival"

Interventions

DRUGGEMCITABINE

DRUGPEGFILGRASTIM

DRUGPACLITAXEL ALBUMIN-BOUND

DRUGBL-B01D1

DRUGCAPECITABINE

DRUGCARBOPLATIN

DRUGPACLITAXEL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
PFS (progression-free survival) by BICR (Blinded Independent Central Review) The ability of iza-bren to work better than other common treatments chosen by the doctors is tested by looking at the PFS, which shows how long it takes for the disease to get worse by radiographic imaging techniques (like CT scans).	—

Secondary

Measure	Time frame
This study will assess if people live longer when they take iza-bren compared to other treatments chosen by the doctors. This is what is called "Overall Survival"	—

Countries

Austria, France, Germany, Greece, Italy, Poland, Portugal, Romania, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026