Recruiting 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)

Phase II / Phase III Interventional Breast Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine.
Who it may be relevant to: Registry conditions: Breast Neoplasms. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Austria, Brazil +23
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

Drug Iza-bren
Specified dose on specified days
Drug Nab-paclitaxel
Specified dose on specified days
Drug Paclitaxel
Specified dose on specified days
Drug Capecitabine
Specified dose on specified days
Drug Carboplatin
Specified dose on specified days
Drug Gemcitabine
Specified dose on specified days

Primary outcome measures

Progression-Free Survival (PFS) [Time frame: Approximately 31 months from first participant randomization]

Secondary outcome measures (12)

Overall Survival (OS) [Time frame: Approximately up to 57 months from first participant randomization]
Recommended Phase 3 Dose (RP3D) of BMS-986507 [Time frame: Approximately 19 months from first participant randomization]
Number of participants with treatment-related Adverse Events (AEs) [Time frame: Approximately up to 57 months from first participant randomization]
Number of participants with laboratory abnormalities [Time frame: Approximately up to 57 months from first participant randomization]
Number of participants with serious AEs (SAEs) [Time frame: Approximately up to 57 months from first participant randomization]
Number of participants with AEs leading to treatment discontinuation, interruption, dose reduction or dose delay [Time frame: Approximately up to 57 months from first participant randomization]
Number of deaths [Time frame: Approximately up to 57 months from first participant randomization]
Objective Response (OR) [Time frame: Approximately 31 months from first participant randomization]
PFS rate [Time frame: Approximately 19 months from first participant randomization]
PFS [Time frame: Approximately 31 months from first participant randomization]
Disease control rate (DCR) [Time frame: Approximately 31 months from first participant randomization]
Duration of Response (DOR) [Time frame: Approximately 31 months from first participant randomization]

Eligibility criteria

Inclusion criteria

Histologically or cytologically confirmed and documented locally-advanced, recurrent inoperable, or metastatic TNBC (ER < 1%, PgR < 1%, HER2 IHC 0, 1+, or 2+ with ISH 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 ISH 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:

i) Investigator-determined ineligibility based on PD-L1 negative disease determined and documented prior to trial screening as part of SoC; ii) Has experienced disease relapse between 6 to 12 months after the completion of (neo)adjuvant therapy with an anti-PD(L)1; iii) 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment