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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06926868




Registration number
NCT06926868
Ethics application status
Date submitted
8/04/2025
Date registered
15/04/2025

Titles & IDs
Public title
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)
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
Secondary ID [1] 0 0
2024-519871-24
Secondary ID [2] 0 0
CA244-0008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Iza-bren
Treatment: Drugs - Nab-paclitaxel
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Capecitabine
Treatment: Drugs - Carboplatin
Treatment: Drugs - Gemcitabine

Experimental: Arm A1 -

Experimental: Arm A2 -

Active comparator: Arm B -


Treatment: Drugs: Iza-bren
Specified dose on specified days

Treatment: Drugs: Nab-paclitaxel
Specified dose on specified days

Treatment: Drugs: Paclitaxel
Specified dose on specified days

Treatment: Drugs: Capecitabine
Specified dose on specified days

Treatment: Drugs: Carboplatin
Specified dose on specified days

Treatment: Drugs: Gemcitabine
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
Approximately 31 months from first participant randomization
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Approximately up to 57 months from first participant randomization
Secondary outcome [2] 0 0
Recommended Phase 3 Dose (RP3D) of BMS-986507
Timepoint [2] 0 0
Approximately 19 months from first participant randomization
Secondary outcome [3] 0 0
Number of participants with treatment-related Adverse Events (AEs)
Timepoint [3] 0 0
Approximately up to 57 months from first participant randomization
Secondary outcome [4] 0 0
Number of participants with laboratory abnormalities
Timepoint [4] 0 0
Approximately up to 57 months from first participant randomization
Secondary outcome [5] 0 0
Number of participants with serious AEs (SAEs)
Timepoint [5] 0 0
Approximately up to 57 months from first participant randomization
Secondary outcome [6] 0 0
Number of participants with AEs leading to treatment discontinuation, interruption, dose reduction or dose delay
Timepoint [6] 0 0
Approximately up to 57 months from first participant randomization
Secondary outcome [7] 0 0
Number of deaths
Timepoint [7] 0 0
Approximately up to 57 months from first participant randomization
Secondary outcome [8] 0 0
Objective Response (OR)
Timepoint [8] 0 0
Approximately 31 months from first participant randomization
Secondary outcome [9] 0 0
PFS rate
Timepoint [9] 0 0
Approximately 31 months from first participant randomization
Secondary outcome [10] 0 0
PFS
Timepoint [10] 0 0
Approximately 31 months from first participant randomization
Secondary outcome [11] 0 0
Disease control rate (DCR)
Timepoint [11] 0 0
Approximately 31 months from first participant randomization
Secondary outcome [12] 0 0
Duration of Response (DOR)
Timepoint [12] 0 0
Approximately 31 months from first participant randomization
Secondary outcome [13] 0 0
Time to Response (TTR)
Timepoint [13] 0 0
Approximately 31 months from first participant randomization
Secondary outcome [14] 0 0
Time to subsequent treatment (TTST)
Timepoint [14] 0 0
Approximately up to 57 months from first participant randomization
Secondary outcome [15] 0 0
Progression-free survival after next line of treatment (PFS2)
Timepoint [15] 0 0
Approximately up to 57 months from first participant randomization
Secondary outcome [16] 0 0
Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Timepoint [16] 0 0
Approximately up to 57 months from first participant randomization
Secondary outcome [17] 0 0
Change from baseline in EORTC Breast Cancer-specific Quality of Life Questionnaire (QLQ-BR23)
Timepoint [17] 0 0
Approximately up to 57 months from first participant randomization
Secondary outcome [18] 0 0
Functional Assessment of Chronic Illness Therapy item GP5 (FACIT GP5) score
Timepoint [18] 0 0
Approximately up to 57 months from first participant randomization
Secondary outcome [19] 0 0
Change from baseline in European Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L)
Timepoint [19] 0 0
Approximately up to 57 months from first participant randomization

Eligibility
Key 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 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/
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
15/07/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/05/2030
Actual
Sample size
Target
560
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0035 - Brisbane
Recruitment hospital [2] 0 0
Local Institution - 0197 - Ballarat Central
Recruitment hospital [3] 0 0
Local Institution - 0031 - Heidelberg
Recruitment hospital [4] 0 0
Local Institution - 0274 - Melbourne
Recruitment hospital [5] 0 0
Local Institution - 0028 - Subiaco
Recruitment postcode(s) [1] 0 0
4029 - Brisbane
Recruitment postcode(s) [2] 0 0
3350 - Ballarat Central
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
3000 - Melbourne
Recruitment postcode(s) [5] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Delaware
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Oregon
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
South Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
Argentina
State/province [18] 0 0
Buenos Aires
Country [19] 0 0
Argentina
State/province [19] 0 0
Ciudad Autónoma De Buenos Aires
Country [20] 0 0
Argentina
State/province [20] 0 0
Córdoba
Country [21] 0 0
Argentina
State/province [21] 0 0
Santa Fe
Country [22] 0 0
Argentina
State/province [22] 0 0
Ciudad Autónoma de Buenos Aires
Country [23] 0 0
Argentina
State/province [23] 0 0
Cordoba
Country [24] 0 0
Austria
State/province [24] 0 0
Steiermark
Country [25] 0 0
Austria
State/province [25] 0 0
Tirol
Country [26] 0 0
Austria
State/province [26] 0 0
Salzburg
Country [27] 0 0
Austria
State/province [27] 0 0
St. Polten
Country [28] 0 0
Austria
State/province [28] 0 0
Wien
Country [29] 0 0
Brazil
State/province [29] 0 0
Amazonas
Country [30] 0 0
Brazil
State/province [30] 0 0
Ceará
Country [31] 0 0
Brazil
State/province [31] 0 0
Espírito Santo
Country [32] 0 0
Brazil
State/province [32] 0 0
Rio Grande Do Sul
Country [33] 0 0
Brazil
State/province [33] 0 0
São Paulo
Country [34] 0 0
Brazil
State/province [34] 0 0
Rio de Janeiro
Country [35] 0 0
Canada
State/province [35] 0 0
British Columbia
Country [36] 0 0
Canada
State/province [36] 0 0
Ontario
Country [37] 0 0
Canada
State/province [37] 0 0
Quebec
Country [38] 0 0
Colombia
State/province [38] 0 0
Antioquia
Country [39] 0 0
Colombia
State/province [39] 0 0
Atlántico
Country [40] 0 0
Colombia
State/province [40] 0 0
COR
Country [41] 0 0
Colombia
State/province [41] 0 0
Valle Del Cauca
Country [42] 0 0
France
State/province [42] 0 0
Aquitaine
Country [43] 0 0
France
State/province [43] 0 0
Côte-d'Or
Country [44] 0 0
France
State/province [44] 0 0
Haute-Garonne
Country [45] 0 0
France
State/province [45] 0 0
Hérault
Country [46] 0 0
France
State/province [46] 0 0
Ille-et-Vilaine
Country [47] 0 0
France
State/province [47] 0 0
Loire-Atlantique
Country [48] 0 0
France
State/province [48] 0 0
Marne
Country [49] 0 0
France
State/province [49] 0 0
Paris
Country [50] 0 0
France
State/province [50] 0 0
Provence-Alpes-Côte-d'Azur
Country [51] 0 0
France
State/province [51] 0 0
Puy-de-Dôme
Country [52] 0 0
France
State/province [52] 0 0
Rhône-Alpes
Country [53] 0 0
France
State/province [53] 0 0
Lille
Country [54] 0 0
Germany
State/province [54] 0 0
Bayern
Country [55] 0 0
Germany
State/province [55] 0 0
Hessen
Country [56] 0 0
Germany
State/province [56] 0 0
Nordrhein-Westfalen
Country [57] 0 0
Germany
State/province [57] 0 0
Sachsen
Country [58] 0 0
Germany
State/province [58] 0 0
Schleswig-Holstein
Country [59] 0 0
Germany
State/province [59] 0 0
Berlin
Country [60] 0 0
Germany
State/province [60] 0 0
Bonn
Country [61] 0 0
Germany
State/province [61] 0 0
Dresden
Country [62] 0 0
Germany
State/province [62] 0 0
Hannover
Country [63] 0 0
Germany
State/province [63] 0 0
Heidelberg
Country [64] 0 0
Germany
State/province [64] 0 0
Ulm
Country [65] 0 0
Greece
State/province [65] 0 0
Attikí
Country [66] 0 0
Greece
State/province [66] 0 0
Irakleío
Country [67] 0 0
India
State/province [67] 0 0
Delhi
Country [68] 0 0
India
State/province [68] 0 0
Maharashtra
Country [69] 0 0
India
State/province [69] 0 0
Tamil Nadu
Country [70] 0 0
India
State/province [70] 0 0
Telangana
Country [71] 0 0
India
State/province [71] 0 0
Uttar Pradesh
Country [72] 0 0
Israel
State/province [72] 0 0
HaMerkaz
Country [73] 0 0
Israel
State/province [73] 0 0
HaTsafon
Country [74] 0 0
Israel
State/province [74] 0 0
Yerushalayim
Country [75] 0 0
Italy
State/province [75] 0 0
Campania
Country [76] 0 0
Italy
State/province [76] 0 0
Emilia-Romagna
Country [77] 0 0
Italy
State/province [77] 0 0
Friuli-Venezia Giulia
Country [78] 0 0
Italy
State/province [78] 0 0
Liguria
Country [79] 0 0
Italy
State/province [79] 0 0
Pisa
Country [80] 0 0
Italy
State/province [80] 0 0
Toscana
Country [81] 0 0
Italy
State/province [81] 0 0
Milano
Country [82] 0 0
Italy
State/province [82] 0 0
Napoli
Country [83] 0 0
Italy
State/province [83] 0 0
Novara
Country [84] 0 0
Italy
State/province [84] 0 0
Padova
Country [85] 0 0
Italy
State/province [85] 0 0
Roma
Country [86] 0 0
Japan
State/province [86] 0 0
Aichi
Country [87] 0 0
Japan
State/province [87] 0 0
Chiba
Country [88] 0 0
Japan
State/province [88] 0 0
Ehime
Country [89] 0 0
Japan
State/province [89] 0 0
Gunma
Country [90] 0 0
Japan
State/province [90] 0 0
Hokkaido
Country [91] 0 0
Japan
State/province [91] 0 0
Ishikawa
Country [92] 0 0
Japan
State/province [92] 0 0
Kanagawa
Country [93] 0 0
Japan
State/province [93] 0 0
Mie
Country [94] 0 0
Japan
State/province [94] 0 0
Miyagi
Country [95] 0 0
Japan
State/province [95] 0 0
Osaka
Country [96] 0 0
Japan
State/province [96] 0 0
Saitama
Country [97] 0 0
Japan
State/province [97] 0 0
Tokyo
Country [98] 0 0
Japan
State/province [98] 0 0
Fukuoka
Country [99] 0 0
Japan
State/province [99] 0 0
Fukushima
Country [100] 0 0
Japan
State/province [100] 0 0
Hiroshima
Country [101] 0 0
Japan
State/province [101] 0 0
Kagoshima
Country [102] 0 0
Japan
State/province [102] 0 0
Kyoto
Country [103] 0 0
Japan
State/province [103] 0 0
Okayama
Country [104] 0 0
Korea, Republic of
State/province [104] 0 0
Kyonggi-do
Country [105] 0 0
Korea, Republic of
State/province [105] 0 0
Seoul-teukbyeolsi [Seoul]
Country [106] 0 0
Korea, Republic of
State/province [106] 0 0
Taegu-Kwangyokshi
Country [107] 0 0
Mexico
State/province [107] 0 0
DIF
Country [108] 0 0
Mexico
State/province [108] 0 0
Jalisco
Country [109] 0 0
Mexico
State/province [109] 0 0
Nuevo León
Country [110] 0 0
Mexico
State/province [110] 0 0
Oaxaca
Country [111] 0 0
Mexico
State/province [111] 0 0
Yucatán
Country [112] 0 0
Mexico
State/province [112] 0 0
Chihuahua
Country [113] 0 0
Poland
State/province [113] 0 0
Lubelskie
Country [114] 0 0
Poland
State/province [114] 0 0
Mazowieckie
Country [115] 0 0
Poland
State/province [115] 0 0
Opolskie
Country [116] 0 0
Poland
State/province [116] 0 0
Wielkopolskie
Country [117] 0 0
Poland
State/province [117] 0 0
Lódzkie
Country [118] 0 0
Portugal
State/province [118] 0 0
Lisboa
Country [119] 0 0
Portugal
State/province [119] 0 0
Coimbra
Country [120] 0 0
Portugal
State/province [120] 0 0
Porto
Country [121] 0 0
Romania
State/province [121] 0 0
Bistri?a-Nasaud
Country [122] 0 0
Romania
State/province [122] 0 0
Bucure?ti
Country [123] 0 0
Romania
State/province [123] 0 0
Cluj
Country [124] 0 0
Romania
State/province [124] 0 0
Dolj
Country [125] 0 0
Romania
State/province [125] 0 0
Timi?
Country [126] 0 0
Romania
State/province [126] 0 0
Ia?i
Country [127] 0 0
Romania
State/province [127] 0 0
Ploie?ti
Country [128] 0 0
Spain
State/province [128] 0 0
A Coruña [La Coruña]
Country [129] 0 0
Spain
State/province [129] 0 0
Alicante
Country [130] 0 0
Spain
State/province [130] 0 0
Barcelona [Barcelona]
Country [131] 0 0
Spain
State/province [131] 0 0
Catalunya [Cataluña]
Country [132] 0 0
Spain
State/province [132] 0 0
Gipuzkoa
Country [133] 0 0
Spain
State/province [133] 0 0
Madrid, Comunidad De
Country [134] 0 0
Spain
State/province [134] 0 0
Málaga
Country [135] 0 0
Spain
State/province [135] 0 0
Valenciana, Comunitat
Country [136] 0 0
Spain
State/province [136] 0 0
Madrid
Country [137] 0 0
Spain
State/province [137] 0 0
Sevilla
Country [138] 0 0
Sweden
State/province [138] 0 0
Skåne Län [se-12]
Country [139] 0 0
Sweden
State/province [139] 0 0
Stockholms Län [se-01]
Country [140] 0 0
Sweden
State/province [140] 0 0
Uppsala Län [se-03]
Country [141] 0 0
Sweden
State/province [141] 0 0
Örebro Län [se-18]
Country [142] 0 0
Sweden
State/province [142] 0 0
Östergötlands Län [se-05]
Country [143] 0 0
Switzerland
State/province [143] 0 0
Sankt Gallen
Country [144] 0 0
Switzerland
State/province [144] 0 0
Vaud
Country [145] 0 0
Switzerland
State/province [145] 0 0
Zürich
Country [146] 0 0
United Arab Emirates
State/province [146] 0 0
Abu Z¸aby
Country [147] 0 0
United Arab Emirates
State/province [147] 0 0
Abu Dhabi
Country [148] 0 0
United Kingdom
State/province [148] 0 0
England
Country [149] 0 0
United Kingdom
State/province [149] 0 0
London, City Of
Country [150] 0 0
United Kingdom
State/province [150] 0 0
Belfast
Country [151] 0 0
United Kingdom
State/province [151] 0 0
London
Country [152] 0 0
United Kingdom
State/province [152] 0 0
Manchester
Country [153] 0 0
United Kingdom
State/province [153] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
SystImmune Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BMS Study Connect Contact Center www.BMSStudyConnect.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06926868