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RecruitingLast updated: 22 December 2025

IZABRIGHT-Breast01: Targeted chemotherapy compared to standard chemotherapy for the treatment of advanced or metastatic triple negative breast cancer and ER-low, HER2-negative breast cancerA 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Breast Cancers Breast

Age

People18+

Trial acronym

IZABRIGHT-Breast01

Clinical summary

Summary

The purpose of this study is to assess how safe and effective a medicine called iza-bren is compared to physician's choice of chemotherapy regimen for the treatment of first-line metastatic triple-negative breast cancer (TNBC) or ER-low HER2-negative breast cancer.

Iza-bren is a bispecific antibody-drug conjugate, which is a form of targeted chemotehrapy. Iza-bren binds to EGFR and HER3 proteins on cancer cells to deliver targeted chemotherapy into the cell.

Study details
Eligible participants will be randomly allocated (by chance) to one of three arms to receive the following treatments:

  • Arm A1: Iza-bren
  • Arm A2: Iza-bren
  • Arm B: physician's choice of chemotherapy (paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, and capecitabine) 

More detail about eligibility and prior treatment history
People with recurrent disease must have experienced relapsed in at least 6 months after finishing their last treatment. People with TNBC must be considered ineligible for first-line chemotherapy combination treatment with an anti-PD-1 or an anti-PD-L1, and people with ER-low, HER2-negative breast cancer must be ineligible for hormone therapy-based treatments. No previous systemic therapy in the advanced disease setting is allowed.

 

Conditions

This trial is treating people with locally advanced, recurrent, inoperable, or metastatic triple negative breast cancer or ER-low, HER2-negative breast cancer

Eligibility

Inclusion

  • 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.
  • Patients with recurrent disease must have experienced disease relapse at least 6 months after finishing their last therapy with curative intent.
  • 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:.
  • Investigator-determined ineligibility based on PD-L1 negative disease determined and documented prior to trial screening as part of SoC.
  • Has experienced disease relapse between 6 to 12 months after the completion of (neo)adjuvant therapy with an anti-PD(L)1.
  • Has a severe auto-immune disease or other contraindication.
  • Patients with ER-low, HER2-negative BC must be ineligible, in the opinion of the Investigator, for endocrine therapy-based treatments.
  • No previous systemic therapy in the locally advanced, recurrent inoperable or metastatic setting (ie incurable setting).
  • Measurable disease by CT or MRI as per RECIST v1.1.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

  • NCT06926868 *
  • 2024-519871-24 *
  • CA244-0008; U1111-1316-1533

Trial sponsor

Bristol-Myers Squibb

Scientific 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

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