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)
- Conditions
- Breast Neoplasms
- Interventions
- Registration Number
- NCT06926868
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 560
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A1 Iza-bren - Arm A2 Iza-bren - Arm B Nab-paclitaxel - Arm B Paclitaxel - Arm B Capecitabine - Arm B Carboplatin - Arm B Gemcitabine -
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) Approximately 31 months from first participant randomization Assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by blinded independent central review (BICR)
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) Approximately up to 57 months from first participant randomization Recommended Phase 3 Dose (RP3D) of BMS-986507 Approximately 19 months from first participant randomization Number of participants with treatment-related Adverse Events (AEs) Approximately up to 57 months from first participant randomization Number of participants with laboratory abnormalities Approximately up to 57 months from first participant randomization Number of participants with serious AEs (SAEs) Approximately up to 57 months from first participant randomization Number of participants with AEs leading to treatment discontinuation, interruption, dose reduction or dose delay Approximately up to 57 months from first participant randomization Number of deaths Approximately up to 57 months from first participant randomization Objective Response (OR) Approximately 31 months from first participant randomization PFS rate Approximately 31 months from first participant randomization Assessed using RECIST v1.1 by BICR
PFS Approximately 31 months from first participant randomization Assessed by Investigator
Disease control rate (DCR) Approximately 31 months from first participant randomization Duration of Response (DOR) Approximately 31 months from first participant randomization Time to Response (TTR) Approximately 31 months from first participant randomization Time to subsequent treatment (TTST) Approximately up to 57 months from first participant randomization Defined as time from randomization to the start of subsequent therapy or death
Progression-free survival after next line of treatment (PFS2) Approximately up to 57 months from first participant randomization 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
Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Approximately up to 57 months from first participant randomization Change from baseline in EORTC Breast Cancer-specific Quality of Life Questionnaire (QLQ-BR23) Approximately up to 57 months from first participant randomization Functional Assessment of Chronic Illness Therapy item GP5 (FACIT GP5) score Approximately up to 57 months from first participant randomization Change from baseline in European Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L) Approximately up to 57 months from first participant randomization
Related Research Topics
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Trial Locations
- Locations (220)
Local Institution - 0303
🇺🇸Hot Springs, Arkansas, United States
Local Institution - 0307
🇺🇸Cerritos, California, United States
Local Institution - 0308
🇺🇸Cerritos, California, United States
Local Institution - 0309
🇺🇸Cerritos, California, United States
Local Institution - 0282
🇺🇸Miami, Florida, United States
Local Institution - 0311
🇺🇸Long Beach, California, United States
Local Institution - 0290
🇺🇸Los Angeles, California, United States
Local Institution - 0283
🇺🇸Los Angeles, California, United States
Local Institution - 0289
🇺🇸Aurora, Colorado, United States
Local Institution - 0304
🇺🇸Newark, Delaware, United States
Local Institution - 0296
🇺🇸Pembroke Pines, Florida, United States
Local Institution - 0278
🇺🇸Chicago, Illinois, United States
Local Institution - 0294
🇺🇸Atlanta, Georgia, United States
Local Institution - 0324
🇺🇸O'Fallon, Illinois, United States
Local Institution - 0286
🇺🇸Covington, Louisiana, United States
Local Institution - 0288
🇺🇸Boston, Massachusetts, United States
Local Institution - 0287
🇺🇸Boston, Massachusetts, United States
Local Institution - 0313
🇺🇸Minneapolis, Minnesota, United States
Local Institution - 0284
🇺🇸Kansas City, Missouri, United States
Local Institution - 0312
🇺🇸New York, New York, United States
Local Institution - 0279
🇺🇸New York, New York, United States
Local Institution - 0295
🇺🇸Westbury, New York, United States
Local Institution - 0280
🇺🇸Chicago, Illinois, United States
Local Institution - 0275
🇺🇸Decatur, Illinois, United States
Local Institution - 0285
🇺🇸White Plains, New York, United States
Local Institution - 0276
🇺🇸Durham, North Carolina, United States
Local Institution - 0316
🇺🇸Eugene, Oregon, United States
Local Institution - 0310
🇺🇸Philadelphia, Pennsylvania, United States
Local Institution - 0281
🇺🇸Greenville, South Carolina, United States
Local Institution - 0315
🇺🇸Austin, Texas, United States
Local Institution - 0314
🇺🇸Houston, Texas, United States
Local Institution - 0305
🇺🇸Tyler, Texas, United States
Local Institution - 0277
🇺🇸Midlothian, Virginia, United States
Local Institution - 0301
🇺🇸Roanoke, Virginia, United States
Local Institution - 0302
🇺🇸Winchester, Virginia, United States
Local Institution - 0011
🇦🇷Ciudad autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0214
🇦🇷ABB, Ciudad Autónoma De Buenos Aires, Argentina
Local Institution - 0137
🇦🇷Río Cuarto, Córdoba, Argentina
Local Institution - 0142
🇦🇷Rosario, Santa Fe, Argentina
Local Institution - 0317
🇦🇷Buenos Aires, Argentina
Local Institution - 0012
🇦🇷Ciudad Autónoma de Buenos Aires, Argentina
Local Institution - 0143
🇦🇷Cordoba, Argentina
Local Institution - 0035
🇦🇺Brisbane, Queensland, Australia
Local Institution - 0197
🇦🇺Ballarat Central, Victoria, Australia
Local Institution - 0031
🇦🇺Heidelberg, Victoria, Australia
Local Institution - 0274
🇦🇺Melbourne, Victoria, Australia
Local Institution - 0028
🇦🇺Subiaco, Western Australia, Australia
Local Institution - 0292
🇦🇹Graz, Steiermark, Austria
Local Institution - 0268
🇦🇹Innsbruck, Tirol, Austria
Local Institution - 0267
🇦🇹Salzburg, Austria
Local Institution - 0270
🇦🇹St. Polten, Austria
Local Institution - 0269
🇦🇹Wien, Austria
Local Institution - 0187
🇧🇷Manaus, Amazonas, Brazil
Local Institution - 0147
🇧🇷Fortaleza, Ceará, Brazil
Local Institution - 0157
🇧🇷Vitória, Espírito Santo, Brazil
Local Institution - 0199
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Local Institution - 0164
🇧🇷São José do Rio Preto, São Paulo, Brazil
Local Institution - 0153
🇧🇷Rio de Janeiro, Brazil
Local Institution - 0144
🇧🇷São Paulo, Brazil
Local Institution - 0149
🇧🇷São Paulo, Brazil
Local Institution - 0218
🇨🇦Kelowna, British Columbia, Canada
Local Institution - 0217
🇨🇦Victoria, British Columbia, Canada
Local Institution - 0265
🇨🇦Ottawa, Ontario, Canada
Local Institution - 0215
🇨🇦Montréal, Quebec, Canada
Local Institution - 0219
🇨🇦Montréal, Quebec, Canada
Local Institution - 0216
🇨🇦Sherbrooke, Quebec, Canada
Local Institution - 0195
🇨🇴Medellín, Antioquia, Colombia
Local Institution - 0201
🇨🇴Rionegro, Antioquia, Colombia
Local Institution - 0194
🇨🇴Barranquilla, Atlántico, Colombia
Local Institution - 0182
🇨🇴Puerto Colombia, Atlántico, Colombia
Local Institution - 0181
🇨🇴Montería, COR, Colombia
Local Institution - 0327
🇨🇴Bogota, Cundinamarca, Colombia
Local Institution - 0183
🇨🇴Cali, Valle Del Cauca, Colombia
Local Institution - 0089
🇫🇷Bordeaux, Aquitaine, France
Local Institution - 0272
🇫🇷Dijon, Côte-d'Or, France
Local Institution - 0098
🇫🇷Toulouse, Haute-Garonne, France
Local Institution - 0095
🇫🇷Montpellier, Hérault, France
Local Institution - 0099
🇫🇷Rennes, Ille-et-Vilaine, France
Local Institution - 0092
🇫🇷Saint Herblain, Loire-Atlantique, France
Local Institution - 0091
🇫🇷Reims, Marne, France
Local Institution - 0097
🇫🇷Villejuif, Paris, France
Local Institution - 0093
🇫🇷Marseille, Provence-Alpes-Côte-d'Azur, France
Local Institution - 0096
🇫🇷Clermont-Ferrand, Puy-de-Dôme, France
Local Institution - 0090
🇫🇷Lyon, Rhône-Alpes, France
Local Institution - 0094
🇫🇷Lille, France
Local Institution - 0088
🇫🇷Paris, France
Local Institution - 0320
🇩🇪Esslingen, Baden-Württemberg, Germany
Local Institution - 0256
🇩🇪Augsburg, Bayern, Germany
Local Institution - 0254
🇩🇪Leipzig, Sachsen, Germany
Local Institution - 0259
🇩🇪Bonn, Germany
Local Institution - 0271
🇩🇪München, Bayern, Germany
Local Institution - 0260
🇩🇪Berlin, Germany
Local Institution - 0306
🇩🇪Frankfurt, Hessen, Germany
Local Institution - 0293
🇩🇪Düsseldorf, Nordrhein-Westfalen, Germany
Local Institution - 0263
🇩🇪Essen, Nordrhein-Westfalen, Germany
Local Institution - 0255
🇩🇪Lübeck, Schleswig-Holstein, Germany
Local Institution - 0261
🇩🇪Berlin, Germany
Local Institution - 0257
🇩🇪Hannover, Germany
Local Institution - 0258
🇩🇪Dresden, Germany
Local Institution - 0266
🇮🇳New Delhi, Delhi, India
Local Institution - 0262
🇩🇪Heidelberg, Germany
Local Institution - 0291
🇩🇪Ulm, Germany
Local Institution - 0038
🇬🇷Athens, Attikí, Greece
Local Institution - 0086
🇬🇷Heraklion, Irakleío, Greece
Local Institution - 0042
🇬🇷Athens, Attikí, Greece
Local Institution - 0206
🇮🇳New Delhi, Delhi, India
Local Institution - 0044
🇮🇱Ramat Gan, HaMerkaz, Israel
Local Institution - 0131
🇮🇳Mumbai, Maharashtra, India
Local Institution - 0134
🇮🇳Nagpur, Maharashtra, India
Local Institution - 0125
🇮🇳Chennai, Tamil Nadu, India
Local Institution - 0130
🇮🇳Hyderabad, Telangana, India
Local Institution - 0133
🇮🇳Varanasi, Uttar Pradesh, India
Local Institution - 0186
🇮🇱Petah Tikva, HaMerkaz, Israel
Local Institution - 0048
🇮🇱Hadera, HaTsafon, Israel
Local Institution - 0123
🇮🇱Haifa, HaTsafon, Israel
Local Institution - 0047
🇮🇱Jerusalem, Yerushalayim, Israel
Local Institution - 0051
🇮🇹Napoli, Campania, Italy
Local Institution - 0049
🇮🇹Bologna, Emilia-Romagna, Italy
Local Institution - 0055
🇮🇹Prato, Toscana, Italy
Local Institution - 0057
🇮🇹Aviano, Friuli-Venezia Giulia, Italy
Local Institution - 0054
🇮🇹Genova, Liguria, Italy
Local Institution - 0053
🇮🇹Pontedera, Pisa, Italy
Local Institution - 0052
🇮🇹Milano, Italy
Local Institution - 0058
🇮🇹Napoli, Italy
Local Institution - 0061
🇮🇹Novara, Italy
Local Institution - 0056
🇮🇹Padova, Italy
Local Institution - 0062
🇮🇹Roma, Italy
Local Institution - 0236
🇯🇵Nagoya, Aichi, Japan
Local Institution - 0230
🇯🇵Chiba-shi, Chiba, Japan
Local Institution - 0240
🇯🇵Matsuyama, Ehime, Japan
Local Institution - 0226
🇯🇵Otashi, Gunma, Japan
Local Institution - 0222
🇯🇵Sapporo, Hokkaido, Japan
Local Institution - 0177
🇲🇽Mexico City, DIF, Mexico
Local Institution - 0232
🇯🇵Kanazawa, Ishikawa, Japan
Local Institution - 0234
🇯🇵Isehara, Kanagawa, Japan
Local Institution - 0237
🇯🇵Yokohama, Kanagawa, Japan
Local Institution - 0246
🇯🇵Tsu, Mie, Japan
Local Institution - 0223
🇯🇵Sendai-shi, Miyagi, Japan
Local Institution - 0238
🇯🇵Suita, Osaka, Japan
Local Institution - 0227
🇯🇵Hidaka, Saitama, Japan
Local Institution - 0224
🇯🇵Ina-machi, Saitama, Japan
Local Institution - 0231
🇯🇵Bunkyo-ku, Tokyo, Japan
Local Institution - 0229
🇯🇵Chuo-ku, Tokyo, Japan
Local Institution - 0228
🇯🇵Koto, Tokyo, Japan
Local Institution - 0245
🇯🇵Shinagawa, Tokyo, Japan
Local Institution - 0233
🇯🇵Shinjuku-ku, Tokyo, Japan
Local Institution - 0242
🇯🇵Fukuoka, Japan
Local Institution - 0225
🇯🇵Fukushima, Japan
Local Institution - 0243
🇯🇵Hiroshima, Japan
Local Institution - 0244
🇯🇵Kagoshima, Japan
Local Institution - 0235
🇯🇵Kyoto, Japan
Local Institution - 0241
🇯🇵Okayama, Japan
Local Institution - 0239
🇯🇵Osaka, Japan
Local Institution - 0066
🇰🇷Goyang-si, Kyǒnggi-do, Korea, Republic of
Local Institution - 0067
🇰🇷Seongnam, Kyǒnggi-do, Korea, Republic of
Local Institution - 0068
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Local Institution - 0063
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Local Institution - 0071
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Local Institution - 0064
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Local Institution - 0065
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Local Institution - 0069
🇰🇷Daegu, Taegu-Kwangyǒkshi, Korea, Republic of
Local Institution - 0178
🇲🇽Guadalajara, Jalisco, Mexico
Local Institution - 0175
🇲🇽Monterrey, Nuevo León, Mexico
Local Institution - 0173
🇲🇽Oaxaca de Juarez, Oaxaca, Mexico
Local Institution - 0179
🇲🇽Merida, Yucatán, Mexico
Local Institution - 0174
🇲🇽Chihuahua, Mexico
Local Institution - 0074
🇵🇱Biala Podlaska, Lubelskie, Poland
Local Institution - 0072
🇵🇱Warszawa, Mazowieckie, Poland
Local Institution - 0220
🇵🇱Warszawa, Mazowieckie, Poland
Local Institution - 0076
🇵🇱Opole, Opolskie, Poland
Local Institution - 0189
🇵🇱Skórzewo, Wielkopolskie, Poland
Local Institution - 0221
🇵🇱Łódź, Łódzkie, Poland
Local Institution - 0198
🇵🇹Lisbon, Lisboa, Portugal
Local Institution - 0106
🇵🇹Lisbon, Lisboa, Portugal
Local Institution - 0109
🇵🇹Lisbon, Lisboa, Portugal
Local Institution - 0124
🇵🇹Coimbra, Portugal
Local Institution - 0141
🇵🇹Lisboa, Portugal
Local Institution - 0111
🇵🇹Porto, Portugal
Local Institution - 0253
🇵🇹Porto, Portugal
Local Institution - 0212
🇷🇴Bistrita, Bistrița-Năsăud, Romania
Local Institution - 0213
🇷🇴Bucharest, București, Romania
Local Institution - 0079
🇷🇴Florești, Cluj, Romania
Local Institution - 0078
🇷🇴Craiova, Dolj, Romania
Local Institution - 0084
🇷🇴Ploiești, Prahova, Romania
Local Institution - 0085
🇷🇴Timișoara, Timiș, Romania
Local Institution - 0083
🇷🇴București, Romania
Local Institution - 0077
🇷🇴Cluj, Romania
Local Institution - 0081
🇷🇴Iași, Romania
Local Institution - 0080
🇷🇴Iași, Romania
Local Institution - 0105
🇪🇸A Coruña, A Coruña [La Coruña], Spain
Local Institution - 0100
🇪🇸Elche, Alicante, Spain
Local Institution - 0102
🇪🇸Barcelona, Barcelona [Barcelona], Spain
Local Institution - 0172
🇪🇸Hospitalet, Barcelona [Barcelona], Spain
Local Institution - 0140
🇪🇸Barcelona, Catalunya [Cataluña], Spain
Local Institution - 0139
🇪🇸San Sebastian, Gipuzkoa, Spain
Local Institution - 0104
🇪🇸Madrid, Madrid, Comunidad De, Spain
Local Institution - 0108
🇪🇸Madrid, Madrid, Comunidad De, Spain
Local Institution - 0101
🇪🇸Malaga, Málaga, Spain
Local Institution - 0210
🇪🇸Valencia, Valenciana, Comunitat, Spain
Local Institution - 0107
🇪🇸Madrid, Spain
Local Institution - 0103
🇪🇸Sevilla, Spain
Local Institution - 0252
🇸🇪Malmö, Skåne Län [se-12], Sweden
Local Institution - 0026
🇸🇪Stockholm, Stockholms Län [se-01], Sweden
Local Institution - 0025
🇸🇪Uppsala, Uppsala Län [se-03], Sweden
Local Institution - 0024
🇸🇪Örebro, Örebro Län [se-18], Sweden
Local Institution - 0247
🇸🇪Linköping, Östergötlands Län [se-05], Sweden
Local Institution - 0250
🇨🇭st.Gallen, Sankt Gallen, Switzerland
Local Institution - 0249
🇨🇭Lausanne, Vaud, Switzerland
Local Institution - 0251
🇨🇭Zürich, Switzerland
Local Institution - 0318
🇦🇪Abu Dhabi, Abū Z̧aby, United Arab Emirates
Local Institution - 0208
🇬🇧Truro, England, United Kingdom
Local Institution - 0204
🇬🇧London, London, City Of, United Kingdom
Local Institution - 0209
🇬🇧London, London, City Of, United Kingdom
Local Institution - 0323
🇦🇪Abu Dhabi, Abū Z̧aby, United Arab Emirates
Local Institution - 0322
🇦🇪Al Ain, Abū Z̧aby, United Arab Emirates
Local Institution - 0319
🇦🇪Abu Dhabi, United Arab Emirates
Local Institution - 0171
🇬🇧Belfast, United Kingdom
Local Institution - 0004
🇬🇧London, United Kingdom
Local Institution - 0001
🇬🇧Manchester, United Kingdom
Local Institution - 0006
🇬🇧Nottingham, United Kingdom