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
600
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Local Institution - 0303
Hot Springs, Arkansas, United States
NOT_YET_RECRUITINGHelios Clinical Research
Cerritos, California, United States
RECRUITINGLocal Institution - 0307
Cerritos, California, United States
WITHDRAWNLocal Institution - 0308
Cerritos, California, United States
Progression-Free Survival (PFS)
Assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by blinded independent central review (BICR)
Time frame: Approximately 22 months from first participant randomization in Phase 3
Recommended Phase 3 Dose (RP3D) of BMS-986507
Time frame: Approximately 13 months from first participant randomization in Phase 2
Overall Survival (OS)
Time frame: Approximately up to 47 months from first participant randomization in Phase 3
Number of participants with treatment-related Adverse Events (AEs)
Time frame: Approximately up to 47 months from first participant randomization in Phase 3
Number of participants with laboratory abnormalities
Time frame: Approximately up to 47 months from first participant randomization in Phase 3
Number of participants with serious AEs (SAEs)
Time frame: Approximately up to 47 months from first participant randomization in Phase 3
Number of participants with AEs leading to treatment discontinuation, interruption, dose reduction or dose delay
Time frame: Approximately up to 47 months from first participant randomization in Phase 3
Number of deaths
Time frame: Approximately up to 47 months from first participant randomization in Phase 3
Objective Response (OR) per BICR
Time frame: Approximately 22 months from first participant randomization in Phase 3
Objective Response (OR) per Investigator
Time frame: Approximately 22 months from first participant randomization in Phase 3
PFS rate
Assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by BICR
Time frame: Approximately 22 months from first participant randomization in Phase 3
PFS rate
Assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by Investigator
Time frame: Approximately 22 months from first participant randomization in Phase 3
Relative change in tumor size
Time frame: Approximately 22 months from first participant randomization in Phase 3
Disease control rate (DCR) per BICR
Time frame: Approximately 22 months from first participant randomization in Phase 3
Disease control rate (DCR) per Investigator
Time frame: Approximately 22 months from first participant randomization in Phase 3
PFS
Assessed by Investigator
Time frame: Approximately 22 months from first participant randomization in Phase 3
Duration of Response (DOR) per BICR
Time frame: Approximately 22 months from first participant randomization in Phase 3
Duration of response (DOR) per Investigator
Time frame: Approximately 22 months from first participant randomization in Phase 3
Time to Response (TTR) per BICR
Time frame: Approximately 22 months from first participant randomization in Phase 3
Time to response (TTR) per Investigator
Time frame: Approximately 22 months from first participant randomization in Phase 3
Time to subsequent treatment (TTST) per Investigator
Defined as time from randomization to the start of subsequent therapy or death
Time frame: Approximately up to 47 months from first participant randomization in Phase 3
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 47 months from first participant randomization in Phase 3
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 47 months from first participant randomization in Phase 3
Change from baseline in EORTC Breast Cancer-specific Quality of Life Questionnaire (QLQ-BR23)
Time frame: Approximately up to 47 months from first participant randomization in Phase 3
Functional Assessment of Chronic Illness Therapy item GP5 (FACIT GP5) score
Time frame: Approximately up to 47 months from first participant randomization in Phase 3
Change from baseline in European Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L)
Time frame: Approximately up to 47 months from first participant randomization in Phase 3
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Local Institution - 0309
Cerritos, California, United States
WITHDRAWNLocal Institution - 0311
Long Beach, California, United States
WITHDRAWNUSC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
RECRUITINGValkyrie Clinical Trials
Los Angeles, California, United States
RECRUITINGUSC Norris Oncology/Hematology-Newport Beach
Newport Beach, California, United States
RECRUITINGLocal Institution - 0358
Stanford, California, United States
NOT_YET_RECRUITING...and 285 more locations