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 3RecruitingNCT06926868

Bristol-Myers Squibb500 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

500

Conditions

Breast Neoplasms

Interventions

Iza-bren

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (292)

Local Institution - 0303

Hot Springs, Arkansas, United States

NOT_YET_RECRUITING

Helios Clinical Research

Cerritos, California, United States

RECRUITING

Local Institution - 0307

Cerritos, California, United States

WITHDRAWN

Local Institution - 0308

Cerritos, California, United States

Outcomes

Primary Outcomes

Progression-Free Survival (PFS)

Assessed using Response Evaluation Criteriain Solid Tumors version 1.1 (RECIST v1.1) byblinded independent central review (BICR)

Time frame: Approximately 31 months from first participant randomization

Secondary Outcomes

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

Assessed using RECIST v1.1 by BICR

Time frame: Approximately 19 months from first participant randomization

PFS

Assessed by Investigator

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

Time to Response (TTR)

Time frame: Approximately 31 months from first participant randomization

Time to subsequent treatment (TTST)

Defined as time from randomization to the start of subsequent therapy or death

Time frame: Approximately up to 57 months from first participant randomization

Progression-free survival after next line of treatment (PFS2)

Defined as the time from randomization to the date of investigator-defined documented disease progression after next line of treatment or death due to any cause, whichever comes first

Time frame: Approximately up to 57 months from first participant randomization

Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

Time frame: Approximately up to 57 months from first participant randomization

Change from baseline in EORTC Breast Cancer-specific Quality of Life Questionnaire (QLQ-BR23)

Time frame: Approximately up to 57 months from first participant randomization

Functional Assessment of Chronic Illness Therapy item GP5 (FACIT GP5) score

Time frame: Approximately up to 57 months from first participant randomization

Change from baseline in European Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L)

Time frame: Approximately up to 57 months from first participant randomization

Relative change in tumor size

Time frame: Approximately up to 19 months from first participant randomization

ORR by RECIST v1.1 per Investigator

Time frame: Approximately 31 months from first participant randomization

Central Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286 Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT