Phase
Condition
N/ATreatment
Carboplatin
Gemcitabine
Iza-bren
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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/Exclusion criteria apply.
Study Design
Connect with a study center
Local Institution - 0345
Buenas Aires, Buenos Aires C1049AAG
ArgentinaSite Not Available
Local Institution - 0011
Ciudad autónoma de Buenos Aires, Buenos Aires 1280
ArgentinaSite Not Available
Local Institution - 0214
ABB, Ciudad Autónoma De Buenos Aires 1181
ArgentinaSite Not Available
Local Institution - 0143
Cordoba, Córdoba X5004BAL
ArgentinaSite Not Available
Local Institution - 0137
Río Cuarto, Córdoba X5800ALB
ArgentinaSite Not Available
Local Institution - 0142
Rosario, Santa Fe 2000
ArgentinaSite Not Available
Local Institution - 0317
Buenos Aires, 1426
ArgentinaSite Not Available
Local Institution - 0346
Buenos Aires, 1430
ArgentinaSite Not Available
Local Institution - 0012
Ciudad Autónoma de Buenos Aires, 1426
ArgentinaSite Not Available
Local Institution - 0035
Brisbane, Queensland 4029
AustraliaSite Not Available
Local Institution - 0197
Ballarat Central, Victoria 3350
AustraliaSite Not Available
Local Institution - 0031
Heidelberg, Victoria 3084
AustraliaSite Not Available
Local Institution - 0274
Melbourne, Victoria 3000
AustraliaSite Not Available
Local Institution - 0028
Subiaco, Western Australia 6008
AustraliaSite Not Available
Local Institution - 0292
Graz, Steiermark 8036
AustriaSite Not Available
Local Institution - 0268
Innsbruck, Tirol 6020
AustriaSite Not Available
Local Institution - 0267
Salzburg, 5020
AustriaSite Not Available
Local Institution - 0270
St. Polten, 3100
AustriaSite Not Available
Local Institution - 0269
Wien, 1090
AustriaSite Not Available
Local Institution - 0187
Manaus, Amazonas 69020-030
BrazilSite Not Available
Local Institution - 0147
Fortaleza, Ceará 60135-237
BrazilSite Not Available
Local Institution - 0157
Vitória, Espírito Santo 29055450
BrazilSite Not Available
Local Institution - 0199
Porto Alegre, Rio Grande Do Sul 90470-340
BrazilSite Not Available
Local Institution - 0164
São José do Rio Preto, São Paulo 15090-000
BrazilSite Not Available
Local Institution - 0153
Rio de Janeiro, 20230-130
BrazilSite Not Available
Local Institution - 0144
São Paulo, 01317-000
BrazilSite Not Available
Local Institution - 0149
São Paulo, 01401-002
BrazilSite Not Available
Local Institution - 0218
Kelowna, British Columbia V1Y 5L3
CanadaSite Not Available
Local Institution - 0217
Victoria, British Columbia V8R 6V5
CanadaSite Not Available
Local Institution - 0265
Ottawa, Ontario K1H 8L6
CanadaSite Not Available
Local Institution - 0215
Montréal, Quebec H2X 3E4
CanadaSite Not Available
Local Institution - 0219
Montréal, Quebec H4A 3J1
CanadaSite Not Available
Local Institution - 0350
Saint-Jerome, Quebec J7Z5T3
CanadaSite Not Available
Local Institution - 0216
Sherbrooke, Quebec J1H 5N4
CanadaSite Not Available
Local Institution - 0017
Santiago, Región Metropolitana De Santiago 8330032
ChileSite Not Available
Local Institution - 0018
Santiago, Región Metropolitana De Santiago 8420383
ChileSite Not Available
Local Institution - 0021
Santiago, Región Metropolitana De Santiago 7650568
ChileSite Not Available
Local Institution - 0138
Santiago, Región Metropolitana De Santiago 7500921
ChileSite Not Available
Local Institution - 0016
Viña del Mar, Valparaíso 2520598
ChileSite Not Available
Local Institution - 0195
Medellín, Antioquia 50021
ColombiaSite Not Available
Local Institution - 0201
Rionegro, Antioquia 054047
ColombiaSite Not Available
Local Institution - 0194
Barranquilla, Atlántico 080020
ColombiaSite Not Available
Local Institution - 0182
Puerto Colombia, Atlántico 81001
ColombiaSite Not Available
Local Institution - 0181
Montería, COR 230002
ColombiaSite Not Available
Local Institution - 0327
Bogota, Cundinamarca 111151
ColombiaSite Not Available
Local Institution - 0183
Cali, Valle Del Cauca 760032
ColombiaSite Not Available
Local Institution - 0349
Medellin, 050030
ColombiaSite Not Available
Local Institution - 0089
Bordeaux, Aquitaine 33076
FranceSite Not Available
Local Institution - 0272
Dijon, Côte-d'Or 21079
FranceSite Not Available
Local Institution - 0098
Toulouse, Haute-Garonne 31059
FranceSite Not Available
Local Institution - 0095
Montpellier, Hérault 34298
FranceSite Not Available
Local Institution - 0099
Rennes, Ille-et-Vilaine 35042
FranceSite Not Available
Local Institution - 0092
Saint Herblain, Loire-Atlantique 44805
FranceSite Not Available
Local Institution - 0091
Reims, Marne 51726
FranceSite Not Available
Local Institution - 0097
Villejuif, Paris 94800
FranceSite Not Available
Local Institution - 0093
Marseille, Provence-Alpes-Côte-d'Azur 13273
FranceSite Not Available
Local Institution - 0096
Clermont-Ferrand, Puy-de-Dôme 63011
FranceSite Not Available
Local Institution - 0090
Lyon, Rhône-Alpes 69008
FranceSite Not Available
Local Institution - 0094
Lille, 59000
FranceSite Not Available
Local Institution - 0088
Paris, 75248
FranceSite Not Available
Local Institution - 0320
Esslingen, Baden-Württemberg 73730
GermanySite Not Available
Local Institution - 0256
Augsburg, Bayern 86156
GermanySite Not Available
Local Institution - 0271
München, Bayern 80637
GermanySite Not Available
Local Institution - 0306
Frankfurt, Hessen 60590
GermanySite Not Available
Local Institution - 0333
Langen, Hessen 63225
GermanySite Not Available
Local Institution - 0257
Hannover, Niedersachsen 30625
GermanySite Not Available
Local Institution - 0293
Düsseldorf, Nordrhein-Westfalen 40235
GermanySite Not Available
Local Institution - 0263
Essen, Nordrhein-Westfalen 45136
GermanySite Not Available
Local Institution - 0254
Leipzig, Sachsen 04103
GermanySite Not Available
Local Institution - 0255
Lübeck, Schleswig-Holstein 23538
GermanySite Not Available
Local Institution - 0260
Berlin, 10967
GermanySite Not Available
Local Institution - 0261
Berlin, 10117
GermanySite Not Available
Local Institution - 0259
Bonn, 53111
GermanySite Not Available
Local Institution - 0258
Dresden, 01307
GermanySite Not Available
Local Institution - 0262
Heidelberg, D-69120
GermanySite Not Available
Local Institution - 0291
Ulm, 89081
GermanySite Not Available
Local Institution - 0038
Athens, Attikí 185 47
GreeceSite Not Available
Local Institution - 0042
Athens, Attikí 115 22
GreeceSite Not Available
Local Institution - 0086
Heraklion, Irakleío 715 00
GreeceSite Not Available
Local Institution - 0043
Athens, 115 28
GreeceSite Not Available
Local Institution - 0206
New Delhi, Delhi 110085
IndiaSite Not Available
Local Institution - 0266
New Delhi, Delhi 110029
IndiaSite Not Available
Local Institution - 0131
Mumbai, Maharashtra 400012
IndiaSite Not Available
Local Institution - 0134
Nagpur, Maharashtra 440001
IndiaSite Not Available
Local Institution - 0125
Chennai, Tamil Nadu 600035
IndiaSite Not Available
Local Institution - 0130
Hyderabad, Telangana 500082
IndiaSite Not Available
Local Institution - 0133
Varanasi, Uttar Pradesh 221005
IndiaSite Not Available
Local Institution - 0352
New Delhi, 110017
IndiaSite Not Available
Local Institution - 0186
Petah Tikva, HaMerkaz 4941492
IsraelSite Not Available
Local Institution - 0044
Ramat Gan, HaMerkaz 5265601
IsraelSite Not Available
Local Institution - 0048
Hadera, HaTsafon 38100
IsraelSite Not Available
Local Institution - 0123
Haifa, HaTsafon 3109601
IsraelSite Not Available
Local Institution - 0047
Jerusalem, Yerushalayim 9112001
IsraelSite Not Available
Local Institution - 0051
Napoli, Campania 80131
ItalySite Not Available
Local Institution - 0049
Bologna, Emilia-Romagna 40138
ItalySite Not Available
Local Institution - 0057
Aviano, Friuli-Venezia Giulia 33081
ItalySite Not Available
Local Institution - 0054
Genova, Liguria 16132
ItalySite Not Available
Local Institution - 0053
Pontedera, Pisa 56025
ItalySite Not Available
Local Institution - 0055
Prato, Toscana 59100
ItalySite Not Available
Local Institution - 0052
Milano, 20141
ItalySite Not Available
Local Institution - 0058
Napoli, 80131
ItalySite Not Available
Local Institution - 0061
Novara, 28100
ItalySite Not Available
Local Institution - 0056
Padova, 35128
ItalySite Not Available
Local Institution - 0062
Roma, 00168
ItalySite Not Available
Local Institution - 0236
Nagoya, Aichi 464-8681
JapanSite Not Available
Local Institution - 0230
Chiba-shi, Chiba 260-8717
JapanSite Not Available
Local Institution - 0240
Matsuyama, Ehime 791-0280
JapanSite Not Available
Local Institution - 0226
Otashi, Gunma 373-8550
JapanSite Not Available
Local Institution - 0222
Sapporo, Hokkaido 003-0804
JapanSite Not Available
Local Institution - 0232
Kanazawa, Ishikawa 9208530
JapanSite Not Available
Local Institution - 0234
Isehara, Kanagawa 259-1193
JapanSite Not Available
Local Institution - 0237
Yokohama, Kanagawa 2418515
JapanSite Not Available
Local Institution - 0246
Tsu, Mie 514-8507
JapanSite Not Available
Local Institution - 0223
Sendai-shi, Miyagi 980-8574
JapanSite Not Available
Local Institution - 0238
Suita, Osaka 565-0871
JapanSite Not Available
Local Institution - 0227
Hidaka, Saitama 350-1298
JapanSite Not Available
Local Institution - 0224
Ina-machi, Saitama 362-0806
JapanSite Not Available
Local Institution - 0231
Bunkyo-ku, Tokyo 113-8431
JapanSite Not Available
Local Institution - 0229
Chuo-ku, Tokyo 104-0045
JapanSite Not Available
Local Institution - 0228
Koto, Tokyo 135-8550
JapanSite Not Available
Local Institution - 0245
Shinagawa, Tokyo 142-8666
JapanSite Not Available
Local Institution - 0233
Shinjuku-ku, Tokyo 160-0023
JapanSite Not Available
Local Institution - 0242
Fukuoka, 811-1395
JapanSite Not Available
Local Institution - 0225
Fukushima, 960-1295
JapanSite Not Available
Local Institution - 0243
Hiroshima, 7308518
JapanSite Not Available
Local Institution - 0244
Kagoshima, 892-0833
JapanSite Not Available
Local Institution - 0235
Kyoto, 606-8507
JapanSite Not Available
Local Institution - 0241
Okayama, 700-8558
JapanSite Not Available
Local Institution - 0239
Osaka, 541-8567
JapanSite Not Available
Local Institution - 0066
Goyang-si, Kyǒnggi-do 10408
Korea, Republic ofSite Not Available
Local Institution - 0067
Seongnam, Kyǒnggi-do 13620
Korea, Republic ofSite Not Available
Local Institution - 0063
Seoul, Seoul-teukbyeolsi [Seoul] 03080
Korea, Republic ofSite Not Available
Local Institution - 0064
Seoul, Seoul-teukbyeolsi [Seoul] 05505
Korea, Republic ofSite Not Available
Local Institution - 0065
Seoul, Seoul-teukbyeolsi [Seoul] 06351
Korea, Republic ofSite Not Available
Local Institution - 0068
Seoul, Seoul-teukbyeolsi [Seoul] 02841
Korea, Republic ofSite Not Available
Local Institution - 0071
Seoul, Seoul-teukbyeolsi [Seoul] 03722
Korea, Republic ofSite Not Available
Local Institution - 0069
Daegu, Taegu-Kwangyǒkshi 41404
Korea, Republic ofSite Not Available
Local Institution - 0264
Tijuana, Baja California 22010
MexicoSite Not Available
Local Institution - 0177
Mexico City, DIF 03100
MexicoSite Not Available
Local Institution - 0329
Mexico City, Distrito Federal 14070
MexicoSite Not Available
Local Institution - 0178
Guadalajara, Jalisco 44680
MexicoSite Not Available
Local Institution - 0175
Monterrey, Nuevo León 64320
MexicoSite Not Available
Local Institution - 0176
Monterrey, Nuevo León 64460
MexicoSite Not Available
Local Institution - 0173
Oaxaca de Juarez, Oaxaca 68020
MexicoSite Not Available
Local Institution - 0179
Merida, Yucatán 97000
MexicoSite Not Available
Local Institution - 0174
Chihuahua, 31203
MexicoSite Not Available
Local Institution - 0074
Biala Podlaska, Lubelskie 21-500
PolandSite Not Available
Local Institution - 0072
Warszawa, Mazowieckie 02-781
PolandSite Not Available
Local Institution - 0220
Warszawa, Mazowieckie 03-411
PolandSite Not Available
Local Institution - 0076
Opole, Opolskie 45-061
PolandSite Not Available
Local Institution - 0189
Skórzewo, Wielkopolskie 60-185
PolandSite Not Available
Local Institution - 0221
Łódź, Łódzkie 93-338
PolandSite Not Available
Local Institution - 0106
Lisbon, Lisboa 1400-038
PortugalSite Not Available
Local Institution - 0109
Lisbon, Lisboa 1649-035
PortugalSite Not Available
Local Institution - 0198
Lisbon, Lisboa 1099-023
PortugalSite Not Available
Local Institution - 0124
Coimbra, 3000-075
PortugalSite Not Available
Local Institution - 0141
Lisboa, 1500-650
PortugalSite Not Available
Local Institution - 0111
Porto, 4200-072
PortugalSite Not Available
Local Institution - 0253
Porto, 4200-319
PortugalSite Not Available
Local Institution - 0212
Bistrita, Bistrița-Năsăud 420020
RomaniaSite Not Available
Local Institution - 0213
Bucharest, București 012292
RomaniaSite Not Available
Local Institution - 0079
Florești, Cluj 407280
RomaniaSite Not Available
Local Institution - 0078
Craiova, Dolj 200746
RomaniaSite Not Available
Local Institution - 0084
Ploiești, Prahova 100337
RomaniaSite Not Available
Local Institution - 0211
Dumbravita, Timiș 307160
RomaniaSite Not Available
Local Institution - 0085
Timișoara, Timiș 300239
RomaniaSite Not Available
Local Institution - 0083
București, 011171
RomaniaSite Not Available
Local Institution - 0077
Cluj, 400015
RomaniaSite Not Available
Local Institution - 0080
Iași, 700483
RomaniaSite Not Available
Local Institution - 0081
Iași, 700106
RomaniaSite Not Available
Local Institution - 0351
East London, Eastern Cape 5241
South AfricaSite Not Available
Local Institution - 0342
Parktown, Gauteng 2193
South AfricaSite Not Available
Local Institution - 0336
Pretoria, Gauteng 0083
South AfricaSite Not Available
Local Institution - 0341
Pretoria, Gauteng 0084
South AfricaSite Not Available
Local Institution - 0340
Soweto, Gauteng 2013
South AfricaSite Not Available
Local Institution - 0105
A Coruña, A Coruña [La Coruña] 15006
SpainSite Not Available
Local Institution - 0100
Elche, Alicante 03203
SpainSite Not Available
Local Institution - 0102
Barcelona, Barcelona [Barcelona] 08035
SpainSite Not Available
Local Institution - 0172
Hospitalet, Barcelona [Barcelona] 08907
SpainSite Not Available
Local Institution - 0140
Barcelona, Catalunya [Cataluña] 08036
SpainSite Not Available
Local Institution - 0139
San Sebastian, Gipuzkoa 20014
SpainSite Not Available
Local Institution - 0104
Madrid, Madrid, Comunidad De 28009
SpainSite Not Available
Local Institution - 0108
Madrid, Madrid, Comunidad De 28041
SpainSite Not Available
Local Institution - 0101
Malaga, Málaga 29010
SpainSite Not Available
Local Institution - 0210
Valencia, Valenciana, Comunitat 46010
SpainSite Not Available
Local Institution - 0107
Madrid, 28007
SpainSite Not Available
Local Institution - 0103
Sevilla, 41009
SpainSite Not Available
Local Institution - 0252
Malmö, Skåne Län [se-12] 205 02
SwedenSite Not Available
Local Institution - 0026
Stockholm, Stockholms Län [se-01] 112 19
SwedenSite Not Available
Local Institution - 0025
Uppsala, Uppsala Län [se-03] 751 85
SwedenSite Not Available
Local Institution - 0024
Örebro, Örebro Län [se-18] 701 85
SwedenSite Not Available
Local Institution - 0247
Linköping, Östergötlands Län [se-05] 581 85
SwedenSite Not Available
Local Institution - 0250
st.Gallen, Sankt Gallen 9007
SwitzerlandSite Not Available
Local Institution - 0249
Lausanne, Vaud 1011
SwitzerlandSite Not Available
Local Institution - 0251
Zürich, 8008
SwitzerlandSite Not Available
Local Institution - 0318
Abu Dhabi, Abū Z̧aby 92510
United Arab EmiratesSite Not Available
Local Institution - 0323
Abu Dhabi, Abū Z̧aby 11001
United Arab EmiratesSite Not Available
Local Institution - 0322
Al Ain, Abū Z̧aby 15258
United Arab EmiratesSite Not Available
Local Institution - 0319
Abu Dhabi, 0
United Arab EmiratesSite Not Available
Local Institution - 0208
Truro, England TR1 3LJ
United KingdomSite Not Available
Local Institution - 0204
London, London, City Of SE1 9RT
United KingdomSite Not Available
Local Institution - 0209
London, London, City Of SE1 9RT
United KingdomSite Not Available
Local Institution - 0171
Belfast, BT9 7AB
United KingdomSite Not Available
Local Institution - 0004
London, E1 1BB
United KingdomSite Not Available
Local Institution - 0001
Manchester, M20 4BX
United KingdomSite Not Available
Local Institution - 0006
Nottingham, NG5 1PB
United KingdomSite Not Available
Local Institution - 0303
Hot Springs, Arkansas 71913
United StatesSite Not Available
Local Institution - 0307
Cerritos, California 90703
United StatesSite Not Available
Local Institution - 0308
Cerritos, California 90703
United StatesSite Not Available
Local Institution - 0309
Cerritos, California 90703
United StatesSite Not Available
Local Institution - 0311
Long Beach, California 90805
United StatesSite Not Available
Local Institution - 0283
Los Angeles, California 90067
United StatesSite Not Available
Local Institution - 0290
Los Angeles, California 90033
United StatesSite Not Available
Local Institution - 0328
Whittier, California 90603
United StatesSite Not Available
Local Institution - 0289
Aurora, Colorado 80045
United StatesSite Not Available
Local Institution - 0304
Newark, Delaware 19713
United StatesSite Not Available
Local Institution - 0282
Miami, Florida 33136
United StatesSite Not Available
Local Institution - 0296
Pembroke Pines, Florida 33028
United StatesSite Not Available
Local Institution - 0294
Atlanta, Georgia 30322
United StatesSite Not Available
Local Institution - 0278
Chicago, Illinois 60612
United StatesSite Not Available
Local Institution - 0280
Chicago, Illinois 60637
United StatesSite Not Available
Decatur Memorial Hospital
Decatur, Illinois 62526
United StatesActive - Recruiting
Local Institution - 0275
Decatur, Illinois 62526
United StatesSite Not Available
Local Institution - 0324
O'Fallon, Illinois 62269
United StatesSite Not Available
Local Institution - 0286
Covington, Louisiana 70433
United StatesSite Not Available
Local Institution - 0287
Boston, Massachusetts 02215
United StatesSite Not Available
Local Institution - 0288
Boston, Massachusetts 02114
United StatesSite Not Available
Local Institution - 0313
Minneapolis, Minnesota 55404
United StatesSite Not Available
Local Institution - 0284
Kansas City, Missouri 64111
United StatesSite Not Available
Local Institution - 0279
New York, New York 10021
United StatesSite Not Available
Local Institution - 0312
New York, New York 10016
United StatesSite Not Available
Clinical Research Alliance
Westbury, New York 11590
United StatesActive - Recruiting
Local Institution - 0295
Westbury, New York 11590
United StatesSite Not Available
Local Institution - 0285
White Plains, New York 10601
United StatesSite Not Available
Local Institution - 0276
Durham, North Carolina 27710
United StatesSite Not Available
Local Institution - 0316
Eugene, Oregon 97401
United StatesSite Not Available
Local Institution - 0310
Philadelphia, Pennsylvania 19104-5127
United StatesSite Not Available
Local Institution - 0281
Greenville, South Carolina 29607
United StatesSite Not Available
Local Institution - 0315
Austin, Texas 78705
United StatesSite Not Available
Local Institution - 0314
Houston, Texas 77024-2843
United StatesSite Not Available
Local Institution - 0305
Tyler, Texas 75702
United StatesSite Not Available
Local Institution - 0277
Midlothian, Virginia 23114
United StatesSite Not Available
Local Institution - 0301
Roanoke, Virginia 24014
United StatesSite Not Available
Local Institution - 0302
Winchester, Virginia 22601
United StatesSite Not Available
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