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)

Last updated: July 24, 2025
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

2/3

Condition

N/A

Treatment

Carboplatin

Gemcitabine

Iza-bren

Clinical Study ID

NCT06926868
CA244-0008
U1111-1316-1533
2024-519871-24
  • Ages > 18
  • All Genders

Study 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.

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

Total Participants: 560
Treatment Group(s): 6
Primary Treatment: Carboplatin
Phase: 2/3
Study Start date:
July 15, 2025
Estimated Completion Date:
May 15, 2030

Connect with a study center

  • Local Institution - 0345

    Buenas Aires, Buenos Aires C1049AAG
    Argentina

    Site Not Available

  • Local Institution - 0011

    Ciudad autónoma de Buenos Aires, Buenos Aires 1280
    Argentina

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  • Local Institution - 0214

    ABB, Ciudad Autónoma De Buenos Aires 1181
    Argentina

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  • Local Institution - 0143

    Cordoba, Córdoba X5004BAL
    Argentina

    Site Not Available

  • Local Institution - 0137

    Río Cuarto, Córdoba X5800ALB
    Argentina

    Site Not Available

  • Local Institution - 0142

    Rosario, Santa Fe 2000
    Argentina

    Site Not Available

  • Local Institution - 0317

    Buenos Aires, 1426
    Argentina

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  • Local Institution - 0346

    Buenos Aires, 1430
    Argentina

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  • Local Institution - 0012

    Ciudad Autónoma de Buenos Aires, 1426
    Argentina

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  • Local Institution - 0035

    Brisbane, Queensland 4029
    Australia

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    Ballarat Central, Victoria 3350
    Australia

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    Heidelberg, Victoria 3084
    Australia

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    Melbourne, Victoria 3000
    Australia

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    Subiaco, Western Australia 6008
    Australia

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  • Local Institution - 0292

    Graz, Steiermark 8036
    Austria

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  • Local Institution - 0268

    Innsbruck, Tirol 6020
    Austria

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    Salzburg, 5020
    Austria

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    St. Polten, 3100
    Austria

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    Wien, 1090
    Austria

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    Manaus, Amazonas 69020-030
    Brazil

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    Fortaleza, Ceará 60135-237
    Brazil

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    Vitória, Espírito Santo 29055450
    Brazil

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    Porto Alegre, Rio Grande Do Sul 90470-340
    Brazil

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    São José do Rio Preto, São Paulo 15090-000
    Brazil

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    Rio de Janeiro, 20230-130
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    São Paulo, 01317-000
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    São Paulo, 01401-002
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    Kelowna, British Columbia V1Y 5L3
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    Victoria, British Columbia V8R 6V5
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    Ottawa, Ontario K1H 8L6
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    Montréal, Quebec H2X 3E4
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    Santiago, Región Metropolitana De Santiago 8330032
    Chile

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    Chile

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    Viña del Mar, Valparaíso 2520598
    Chile

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    Medellín, Antioquia 50021
    Colombia

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    Rionegro, Antioquia 054047
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    Barranquilla, Atlántico 080020
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    Puerto Colombia, Atlántico 81001
    Colombia

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    Montería, COR 230002
    Colombia

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    Bogota, Cundinamarca 111151
    Colombia

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    Cali, Valle Del Cauca 760032
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    Medellin, 050030
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    Bordeaux, Aquitaine 33076
    France

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    Dijon, Côte-d'Or 21079
    France

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    Toulouse, Haute-Garonne 31059
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    Montpellier, Hérault 34298
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    Rennes, Ille-et-Vilaine 35042
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    Saint Herblain, Loire-Atlantique 44805
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    Reims, Marne 51726
    France

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    Villejuif, Paris 94800
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    Marseille, Provence-Alpes-Côte-d'Azur 13273
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    Clermont-Ferrand, Puy-de-Dôme 63011
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    Lyon, Rhône-Alpes 69008
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    Lille, 59000
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    Athens, Attikí 115 22
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    Heraklion, Irakleío 715 00
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    Nagpur, Maharashtra 440001
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    Petah Tikva, HaMerkaz 4941492
    Israel

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    Ramat Gan, HaMerkaz 5265601
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    Hadera, HaTsafon 38100
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    Haifa, HaTsafon 3109601
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    Jerusalem, Yerushalayim 9112001
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    Napoli, Campania 80131
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    Bologna, Emilia-Romagna 40138
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    Aviano, Friuli-Venezia Giulia 33081
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    Genova, Liguria 16132
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    Pontedera, Pisa 56025
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    Prato, Toscana 59100
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    Milano, 20141
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    Napoli, 80131
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    Novara, 28100
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    Padova, 35128
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    Roma, 00168
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    Nagoya, Aichi 464-8681
    Japan

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    Chiba-shi, Chiba 260-8717
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    Matsuyama, Ehime 791-0280
    Japan

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    Otashi, Gunma 373-8550
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    Sapporo, Hokkaido 003-0804
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    Kanazawa, Ishikawa 9208530
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    Isehara, Kanagawa 259-1193
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    Yokohama, Kanagawa 2418515
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    Tsu, Mie 514-8507
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    Sendai-shi, Miyagi 980-8574
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    Suita, Osaka 565-0871
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    Hidaka, Saitama 350-1298
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    Ina-machi, Saitama 362-0806
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    Bunkyo-ku, Tokyo 113-8431
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    Chuo-ku, Tokyo 104-0045
    Japan

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    Koto, Tokyo 135-8550
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    Shinagawa, Tokyo 142-8666
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    Shinjuku-ku, Tokyo 160-0023
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    Fukuoka, 811-1395
    Japan

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    Fukushima, 960-1295
    Japan

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    Hiroshima, 7308518
    Japan

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    Kagoshima, 892-0833
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    Kyoto, 606-8507
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    Okayama, 700-8558
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    Osaka, 541-8567
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    Goyang-si, Kyǒnggi-do 10408
    Korea, Republic of

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    Seongnam, Kyǒnggi-do 13620
    Korea, Republic of

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  • Local Institution - 0063

    Seoul, Seoul-teukbyeolsi [Seoul] 03080
    Korea, Republic of

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    Seoul, Seoul-teukbyeolsi [Seoul] 05505
    Korea, Republic of

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  • Local Institution - 0065

    Seoul, Seoul-teukbyeolsi [Seoul] 06351
    Korea, Republic of

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  • Local Institution - 0068

    Seoul, Seoul-teukbyeolsi [Seoul] 02841
    Korea, Republic of

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    Seoul, Seoul-teukbyeolsi [Seoul] 03722
    Korea, Republic of

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  • Local Institution - 0069

    Daegu, Taegu-Kwangyǒkshi 41404
    Korea, Republic of

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  • Local Institution - 0264

    Tijuana, Baja California 22010
    Mexico

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  • Local Institution - 0177

    Mexico City, DIF 03100
    Mexico

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  • Local Institution - 0329

    Mexico City, Distrito Federal 14070
    Mexico

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    Guadalajara, Jalisco 44680
    Mexico

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    Monterrey, Nuevo León 64320
    Mexico

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    Monterrey, Nuevo León 64460
    Mexico

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    Oaxaca de Juarez, Oaxaca 68020
    Mexico

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    Merida, Yucatán 97000
    Mexico

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    Chihuahua, 31203
    Mexico

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    Biala Podlaska, Lubelskie 21-500
    Poland

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    Warszawa, Mazowieckie 02-781
    Poland

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    Warszawa, Mazowieckie 03-411
    Poland

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    Opole, Opolskie 45-061
    Poland

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    Skórzewo, Wielkopolskie 60-185
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    Łódź, Łódzkie 93-338
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    Lisbon, Lisboa 1400-038
    Portugal

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    Lisbon, Lisboa 1649-035
    Portugal

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    Lisbon, Lisboa 1099-023
    Portugal

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    Coimbra, 3000-075
    Portugal

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    Lisboa, 1500-650
    Portugal

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    Porto, 4200-072
    Portugal

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    Porto, 4200-319
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    Bistrita, Bistrița-Năsăud 420020
    Romania

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    Bucharest, București 012292
    Romania

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    Florești, Cluj 407280
    Romania

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    Craiova, Dolj 200746
    Romania

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    Ploiești, Prahova 100337
    Romania

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    Dumbravita, Timiș 307160
    Romania

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    Timișoara, Timiș 300239
    Romania

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    București, 011171
    Romania

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    Cluj, 400015
    Romania

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    Iași, 700483
    Romania

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    Iași, 700106
    Romania

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  • Local Institution - 0351

    East London, Eastern Cape 5241
    South Africa

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    Parktown, Gauteng 2193
    South Africa

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    Pretoria, Gauteng 0083
    South Africa

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  • Local Institution - 0341

    Pretoria, Gauteng 0084
    South Africa

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    Soweto, Gauteng 2013
    South Africa

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  • Local Institution - 0105

    A Coruña, A Coruña [La Coruña] 15006
    Spain

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    Elche, Alicante 03203
    Spain

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    Barcelona, Barcelona [Barcelona] 08035
    Spain

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    Hospitalet, Barcelona [Barcelona] 08907
    Spain

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    Barcelona, Catalunya [Cataluña] 08036
    Spain

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    San Sebastian, Gipuzkoa 20014
    Spain

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    Madrid, Madrid, Comunidad De 28009
    Spain

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    Madrid, Madrid, Comunidad De 28041
    Spain

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    Malaga, Málaga 29010
    Spain

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    Valencia, Valenciana, Comunitat 46010
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    Madrid, 28007
    Spain

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    Sevilla, 41009
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    Malmö, Skåne Län [se-12] 205 02
    Sweden

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    Stockholm, Stockholms Län [se-01] 112 19
    Sweden

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    Uppsala, Uppsala Län [se-03] 751 85
    Sweden

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    Örebro, Örebro Län [se-18] 701 85
    Sweden

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    Linköping, Östergötlands Län [se-05] 581 85
    Sweden

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  • Local Institution - 0250

    st.Gallen, Sankt Gallen 9007
    Switzerland

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    Lausanne, Vaud 1011
    Switzerland

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    Zürich, 8008
    Switzerland

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    Abu Dhabi, Abū Z̧aby 92510
    United Arab Emirates

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    Abu Dhabi, Abū Z̧aby 11001
    United Arab Emirates

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    Al Ain, Abū Z̧aby 15258
    United Arab Emirates

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  • Local Institution - 0319

    Abu Dhabi, 0
    United Arab Emirates

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  • Local Institution - 0208

    Truro, England TR1 3LJ
    United Kingdom

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    London, London, City Of SE1 9RT
    United Kingdom

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    London, London, City Of SE1 9RT
    United Kingdom

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    Belfast, BT9 7AB
    United Kingdom

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    London, E1 1BB
    United Kingdom

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    Manchester, M20 4BX
    United Kingdom

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    Nottingham, NG5 1PB
    United Kingdom

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    Hot Springs, Arkansas 71913
    United States

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    Cerritos, California 90703
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    Cerritos, California 90703
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    Cerritos, California 90703
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    Long Beach, California 90805
    United States

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    Los Angeles, California 90067
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    Los Angeles, California 90033
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    Whittier, California 90603
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    Aurora, Colorado 80045
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    Newark, Delaware 19713
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    Miami, Florida 33136
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    Pembroke Pines, Florida 33028
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    Atlanta, Georgia 30322
    United States

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    Chicago, Illinois 60612
    United States

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    Chicago, Illinois 60637
    United States

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  • Decatur Memorial Hospital

    Decatur, Illinois 62526
    United States

    Active - Recruiting

  • Local Institution - 0275

    Decatur, Illinois 62526
    United States

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    O'Fallon, Illinois 62269
    United States

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    Covington, Louisiana 70433
    United States

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    Boston, Massachusetts 02215
    United States

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    Boston, Massachusetts 02114
    United States

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    Minneapolis, Minnesota 55404
    United States

    Site Not Available

  • Local Institution - 0284

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Local Institution - 0279

    New York, New York 10021
    United States

    Site Not Available

  • Local Institution - 0312

    New York, New York 10016
    United States

    Site Not Available

  • Clinical Research Alliance

    Westbury, New York 11590
    United States

    Active - Recruiting

  • Local Institution - 0295

    Westbury, New York 11590
    United States

    Site Not Available

  • Local Institution - 0285

    White Plains, New York 10601
    United States

    Site Not Available

  • Local Institution - 0276

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Local Institution - 0316

    Eugene, Oregon 97401
    United States

    Site Not Available

  • Local Institution - 0310

    Philadelphia, Pennsylvania 19104-5127
    United States

    Site Not Available

  • Local Institution - 0281

    Greenville, South Carolina 29607
    United States

    Site Not Available

  • Local Institution - 0315

    Austin, Texas 78705
    United States

    Site Not Available

  • Local Institution - 0314

    Houston, Texas 77024-2843
    United States

    Site Not Available

  • Local Institution - 0305

    Tyler, Texas 75702
    United States

    Site Not Available

  • Local Institution - 0277

    Midlothian, Virginia 23114
    United States

    Site Not Available

  • Local Institution - 0301

    Roanoke, Virginia 24014
    United States

    Site Not Available

  • Local Institution - 0302

    Winchester, Virginia 22601
    United States

    Site Not Available

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