A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03)

A Phase 3 Open-label, Randomised Study of Datopotamab Deruxtecan (DatoDXd) With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Who Have Residual Invasive Disease in the Breast and/or Axillary Lymph Nodes at Surgical Resection Following Neoadjuvant Systemic Therapy (TROPION-Breast03)

This is a Phase III, randomized, open-label, 3-arm, multicenter, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with ICT in participants with stage I to III TNBC with residual invasive disease in the breast and/or axillary lymph nodes at surgical resection following neoadjuvant systemic therapy.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Dato-DXd; Drug: Durvalumab; Drug: Capecitabine; Drug: Pembrolizumab

Detailed Description

The study will investigate the efficacy and safety of Dato-DXd with or without durvalumab when compared with ICT (capecitabine and/or pembrolizumab) in participants with stage I to III TNBC who have residual invasive disease in the breast and/or axillary lymph nodes at surgical resection following neoadjuvant systemic therapy.

The primary objective of the study is to demonstrate superiority of Dato-DXd in combination with durvalumab relative to ICT by assessment of iDFS in participants with stage I to III TNBC with residual invasive disease at surgical resection following neoadjuvant therapy.

• Study Type: Interventional
• Enrollment (Estimated): 1075
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• Belgium
  • Anderlecht, Belgium, 1070
    • Recruiting
    • Research Site
  • Brussel, Belgium, 1090
    • Recruiting
    • Research Site
  • Bruxelles, Belgium, 1200
    • Recruiting
    • Research Site
  • Charleroi, Belgium, 6000
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    • Research Site
  • Edegem, Belgium, 2650
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    • Research Site
  • Gent, Belgium, 9000
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  • Hasselt, Belgium, 3500
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  • Liège, Belgium, 4000
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  • Namur, Belgium, 5000
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  • Sint-Niklaas, Belgium, 9100
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  • Wilrijk, Belgium, 2610
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• Brazil
  • Brasilia, Brazil, 71681-603
    • Recruiting
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  • Porto Alegre, Brazil, 90035-000
    • Recruiting
    • Research Site
  • Recife, Brazil, 52010-075
    • Recruiting
    • Research Site
  • Salvador, Brazil, 41253-190
    • Active, not recruiting
    • Research Site
  • Sao Paulo, Brazil, 01323-903
    • Recruiting
    • Research Site
  • Sao Paulo, Brazil, 01321-001
    • Recruiting
    • Research Site
  • Sao Paulo, Brazil, 01508-010
    • Active, not recruiting
    • Research Site
  • São Paulo, Brazil, 03102-002
    • Recruiting
    • Research Site
  • São Paulo, Brazil, 04532-030
    • Recruiting
    • Research Site
  • Vitória, Brazil, 29055-450
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    • Research Site
• Canada
  • British Columbia
    • North Vancouver, British Columbia, Canada, V7L 2L7
      • Recruiting
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  • Ontario
    • Barrie, Ontario, Canada, L4M 6M2
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    • Kingston, Ontario, Canada, K7L 2V7
      • Recruiting
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    • Oakville, Ontario, Canada, L9T 6G2
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    • Ottawa, Ontario, Canada, K1H 8L6
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    • Toronto, Ontario, Canada, M5G 2M9
      • Recruiting
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    • Toronto, Ontario, Canada, M5G 1X5
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  • Quebec
    • Laval, Quebec, Canada, H7M 3L9
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    • Montreal, Quebec, Canada, H4A 3J1
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    • Montreal, Quebec, Canada, H3T 1E2
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    • Montreal, Quebec, Canada, H2X 0C1
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    • Quebec City, Quebec, Canada, G1S 4L8
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  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 4H4
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• China
  • Beijing, China, 100044
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  • Beijing, China, 100142
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  • Bengbu, China, 233060
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  • Changchun, China, 130021
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  • Changsha, China, 410008
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  • Chengdu, China, 610000
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  • Chengdu, China, 610072
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  • Chongqing, China, 400030
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  • Fuzhou, China, 350011
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  • Guangzhou, China, 510120
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  • Guangzhou, China, 510060
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  • Guangzhou, China, 510100
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  • Guangzhou, China, 510700
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  • Haikou, China, 570311
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  • Hangzhou, China, 310020
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  • Hangzhou, China, 310009
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  • Harbin, China, 150081
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  • Hefei, China, 230001
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  • Jinan, China, 250030
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  • Nanchang, China, 330009
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  • Nanjing, China, 210009
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  • Nanjing, China, 210008
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  • Nanning, China, 530021
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  • Qingdao, China, 110016
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  • Shanghai, China, 200025
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  • Shanghai, China, 200032
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  • Shenzhen, China, 518020
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  • Shijiazhuang, China, 050020
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  • Taiyuan, China, 030000
    • Withdrawn
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  • Tianjin, China, 300060
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  • Wuhan, China, 430022
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  • Wuhan, China, 430060
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  • Xi'an, China, 710038
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  • Xiamen, China, 361003
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  • Zhengzhou, China
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• Denmark
  • Aalborg, Denmark, 9000
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  • Copenhagen, Denmark, 2100
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  • Herlev, Denmark, 2730
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  • Herning, Denmark, 7400
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  • Næstved, Denmark, 4700
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  • Odense C, Denmark, 5000
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  • Sønderborg, Denmark, 6400
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  • Vejle, Denmark, 7100
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• France
  • Angers Cedex 02, France, 49055
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  • Bordeaux, France, 33076
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  • Dijon, France, 21000
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  • Epagny Metz-Tessy, France, 74370
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  • Lyon, France, 69008
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  • Montpellier, France, 34070
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  • Nimes, France, 30029
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  • Paris Cedex 05, France, 75248
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  • Poitiers, France, 86021
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  • Rennes, France, 35000
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  • Saint Herblain Cedex, France, 44805
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  • Vandoeuvre Les Nancy, France, 54000
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  • Villejuif Cedex, France, 94805
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• Germany
  • Augsburg, Germany, 86156
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  • Berlin, Germany, 10967
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  • Frankfurt am Main, Germany, 65929
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  • Hamburg, Germany, 20357
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  • Hannover, Germany, 30177
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  • Heilbronn, Germany, 74078
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  • Kiel, Germany, 24105
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  • Langen, Germany, 63225
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  • Leipzig, Germany, 4103
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  • Ludwigsburg, Germany, 71640
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  • Mönchengladbach, Germany, 41061
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  • München, Germany, 80337
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  • Paderborn, Germany, 33098
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  • Regensburg, Germany, 93053
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  • Stuttgart, Germany, 70199
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  • Troisdorf, Germany, 53840
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  • Tübingen, Germany, 72076
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  • Witten, Germany, 58452
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  • Wuppertal, Germany, 42283
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• Greece
  • Athens, Greece, 11528
    • Recruiting
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  • Athens, Greece, 12462
    • Recruiting
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  • Athens, Greece, 12462
    • Not yet recruiting
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  • Athens, Greece, 115 22
    • Recruiting
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  • Athens, Greece, 15123
    • Recruiting
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  • Heraklion, Greece, 71110
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  • Patras, Greece, 26504
    • Recruiting
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  • Thessaloniki, Greece, 54645
    • Recruiting
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  • Thessaloniki, Greece, 54639
    • Not yet recruiting
    • Research Site
• Italy
  • Bologna, Italy, 40138
    • Recruiting
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  • Brescia, Italy, 25123
    • Recruiting
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  • Firenze, Italy, 50134
    • Recruiting
    • Research Site
  • Genova, Italy, 16132
    • Recruiting
    • Research Site
  • Livorno, Italy, 57124
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  • Meldola, Italy, 47014
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  • Messina, Italy, 98158
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    • Research Site
  • Milan, Italy, 20141
    • Recruiting
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  • Milano, Italy, 20132
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  • Napoli, Italy, 80131
    • Recruiting
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  • Padova, Italy, 35128
    • Recruiting
    • Research Site
  • Roma, Italy, 00168
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  • Rozzano, Italy, 20089
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• Japan
  • Akashi-shi, Japan, 673-8558
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  • Chiba-shi, Japan, 260-8717
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  • Chuo-ku, Japan, 104-0045
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  • Fukuoka, Japan, 811-1395
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  • Fukushima-shi, Japan, 960-1295
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  • Hiroshima-shi, Japan, 730-8518
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  • Isehara-shi, Japan, 259-1193
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  • Kashiwa, Japan, 277-8577
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  • Kitaadachi-gun, Japan, 362-0806
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  • Koto-ku, Japan, 135-8550
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  • Kyoto-shi, Japan, 606-8507
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  • Matsuyama-shi, Japan, 791-0280
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  • Nagoya-shi, Japan, 466-8560
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  • Nagoya-shi, Japan, 464-8681
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  • Niigata-shi, Japan, 951-8566
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  • Nishinomiya-shi, Japan, 663-8501
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  • Okayama-shi, Japan, 700-8558
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  • Osaka-shi, Japan, 541-8567
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  • Ota-shi, Japan, 373-8550
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  • Sapporo-shi, Japan, 003-0804
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  • Sendai-shi, Japan, 980-8574
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  • Shinagawa-ku, Japan, 142-8666
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  • Shinjuku-ku, Japan, 162-8655
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  • Tsukuba, Japan, 305-8577
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  • Yokohama-shi, Japan, 241-8515
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• Korea, Republic of
  • Busan, Korea, Republic of, 49241
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  • Daegu, Korea, Republic of, 41404
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  • Goyang-si, Korea, Republic of, 10408
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  • Seongnam-Si, Korea, Republic of, 463-712
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  • Seoul, Korea, Republic of, 03722
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  • Seoul, Korea, Republic of, 05505
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  • Seoul, Korea, Republic of, 06351
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  • Seoul, Korea, Republic of, 03080
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  • Seoul, Korea, Republic of, 02841
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  • Seoul, Korea, Republic of, 06273
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• Puerto Rico
  • San Juan, Puerto Rico, 00918
    • Not yet recruiting
    • Research Site
• Spain
  • Barcelona, Spain, 08028
    • Recruiting
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  • Barcelona, Spain, 8035
    • Recruiting
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  • Bilbao (Vizcaya), Spain, 48013
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  • Elche(Alicante), Spain, 03202
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  • Madrid, Spain, 28040
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  • Madrid, Spain, 28041
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  • Malaga, Spain, 29010
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  • Palma de Mallorca, Spain, 07010
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  • Toledo, Spain, 45007
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  • Valencia, Spain, 46010
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• Sweden
  • Göteborg, Sweden, 413 45
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  • Jönköping, Sweden, 55185
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  • Malmö, Sweden, 20502
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  • Stockholm, Sweden, 118 83
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  • Stockholm, Sweden, 17176
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  • Stockholm, Sweden, 11281
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  • Sundsvall, Sweden, 851 86
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  • Uppsala, Sweden, 751 85
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• Taiwan
  • Hsinchu, Taiwan, 300
    • Recruiting
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  • Taichung, Taiwan, 40447
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  • Tainan City, Taiwan, 70403
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  • Taipei, Taiwan, 10002
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  • Taipei, Taiwan, 112
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  • Taipei, Taiwan, 10449
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  • Taoyuan, Taiwan, 333
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  • Yung Kang City, Taiwan, 71044
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• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
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  • Cardiff, United Kingdom, CF14 2TL
    • Recruiting
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  • Derry, United Kingdom, BT47 6SB
    • Withdrawn
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  • Derry, United Kingdom, BT47 6SB
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  • Edinburgh, United Kingdom, EH4 2XU
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  • Greater London, United Kingdom, SW3 6JJ
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  • London, United Kingdom, EC1A 7BE
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  • London, United Kingdom, SE1 9RT
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  • Manchester, United Kingdom, M20 4BX
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  • Newcastle upon Tyne, United Kingdom, NE7 7AF
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  • Portsmouth, United Kingdom, PO6 3LY
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  • Surrey, United Kingdom, SM2 5PT
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  • Taunton, United Kingdom, TA1 5DA
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• United States
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Recruiting
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  • Arizona
    • Gilbert, Arizona, United States, 85234
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    • Tempe, Arizona, United States, 85284
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    • Tucson, Arizona, United States, 85711
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    • Tucson, Arizona, United States, 85719
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  • Arkansas
    • Hot Springs National Park, Arkansas, United States, 71913
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    • Little Rock, Arkansas, United States, 72205
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    • Springdale, Arkansas, United States, 72762
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  • California
    • Beverly Hills, California, United States, 90211
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    • Costa Mesa, California, United States, 92627
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    • Duarte, California, United States, 91010
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    • Fountain Valley, California, United States, 92708
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    • Fullerton, California, United States, 92835
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    • Harbor City, California, United States, 90710
      • Withdrawn
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    • Irvine, California, United States, 92618
      • Recruiting
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    • La Jolla, California, United States, 92093
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    • Laguna Hills, California, United States, 92653
      • Not yet recruiting
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    • Lakewood, California, United States, 90805
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    • Loma Linda, California, United States, 92354
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    • Long Beach, California, United States, 90806
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    • Los Angeles, California, United States, 90095
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    • Los Angeles, California, United States, 90017
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    • Los Angeles, California, United States, 90024
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    • Newport Beach, California, United States, 92663
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    • Newport Beach, California, United States, 92660
      • Recruiting
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    • Oakland, California, United States, 94611
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    • Orange, California, United States, 92868
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    • Orange, California, United States, 92868
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    • Roseville, California, United States, 95661
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    • Sacramento, California, United States, 95816
      • Withdrawn
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    • San Francisco, California, United States, 94115
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    • Santa Clara, California, United States, 95051
      • Not yet recruiting
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    • Sunnyvale, California, United States, 94086
      • Withdrawn
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    • Torrance, California, United States, 90505
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    • Upland, California, United States, 91786
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    • Vallejo, California, United States, 94589
      • Not yet recruiting
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    • Walnut Creek, California, United States, 94596
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    • West Hollywood, California, United States, 90048
      • Withdrawn
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    • Whittier, California, United States, 90602
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  • Colorado
    • Aurora, Colorado, United States, 80045
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    • Denver, Colorado, United States, 80220
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  • Connecticut
    • New Haven, Connecticut, United States, 06510
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  • Delaware
    • Newark, Delaware, United States, 19713
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  • District of Columbia
    • Washington, District of Columbia, United States, 20007
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  • Florida
    • Altamonte Springs, Florida, United States, 32701
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    • Fort Myers, Florida, United States, 33901
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    • Hollywood, Florida, United States, 33021
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    • Miami Beach, Florida, United States, 33140
      • Not yet recruiting
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    • Orlando, Florida, United States, 32804
      • Withdrawn
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    • Palm Bay, Florida, United States, 32909
      • Withdrawn
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    • Saint Petersburg, Florida, United States, 33705
      • Recruiting
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    • Tallahassee, Florida, United States, 32308
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    • West Palm Beach, Florida, United States, 33401
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  • Georgia
    • Athens, Georgia, United States, 30607
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    • Atlanta, Georgia, United States, 30322
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    • Atlanta, Georgia, United States, 30318
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    • Marietta, Georgia, United States, 30060
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  • Hawaii
    • Honolulu, Hawaii, United States, 96826
      • Withdrawn
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  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Recruiting
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    • Chicago, Illinois, United States, 60611
      • Not yet recruiting
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    • Decatur, Illinois, United States, 62526
      • Not yet recruiting
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    • Maywood, Illinois, United States, 60153
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    • Park Ridge, Illinois, United States, 60068
      • Recruiting
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  • Indiana
    • New Albany, Indiana, United States, 47150
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  • Iowa
    • Des Moines, Iowa, United States, 50314
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    • Iowa City, Iowa, United States, 52242
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  • Kansas
    • Westwood, Kansas, United States, 66205
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  • Kentucky
    • Elizabethtown, Kentucky, United States, 42701
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    • Lexington, Kentucky, United States, 40503
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    • Louisville, Kentucky, United States, 40241
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    • Louisville, Kentucky, United States, 40207
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    • Louisville, Kentucky, United States, 40202
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  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Withdrawn
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    • New Orleans, Louisiana, United States, 70121
      • Recruiting
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  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Recruiting
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    • Baltimore, Maryland, United States, 21201
      • Not yet recruiting
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    • Baltimore, Maryland, United States, 21202
      • Recruiting
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    • Columbia, Maryland, United States, 21044
      • Recruiting
      • Research Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Research Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Not yet recruiting
      • Research Site
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Research Site
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Recruiting
      • Research Site
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Research Site
  • Montana
    • Billings, Montana, United States, 59102
      • Recruiting
      • Research Site
  • Nebraska
    • Omaha, Nebraska, United States, 68198-5885
      • Withdrawn
      • Research Site
  • Nevada
    • Reno, Nevada, United States, 89502
      • Recruiting
      • Research Site
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Recruiting
      • Research Site
    • East Brunswick, New Jersey, United States, 08816
      • Withdrawn
      • Research Site
    • Hackensack, New Jersey, United States, 07601
      • Recruiting
      • Research Site
    • Ridgewood, New Jersey, United States, 07450
      • Not yet recruiting
      • Research Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Not yet recruiting
      • Research Site
    • Albuquerque, New Mexico, United States, 87102
      • Withdrawn
      • Research Site
  • New York
    • Mount Kisco, New York, United States, 10549
      • Not yet recruiting
      • Research Site
    • New York, New York, United States, 10065
      • Recruiting
      • Research Site
    • New York, New York, United States, 10032
      • Recruiting
      • Research Site
    • New York, New York, United States, 10029
      • Not yet recruiting
      • Research Site
    • New York, New York, United States, 10021
      • Recruiting
      • Research Site
    • New York, New York, United States, 10075
      • Recruiting
      • Research Site
    • Rochester, New York, United States, 14642
      • Withdrawn
      • Research Site
    • Sleepy Hollow, New York, United States, 10591
      • Not yet recruiting
      • Research Site
    • Westbury, New York, United States, 11590
      • Recruiting
      • Research Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Recruiting
      • Research Site
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Recruiting
      • Research Site
    • Canton, Ohio, United States, 44710
      • Recruiting
      • Research Site
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • Research Site
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Research Site
    • Cleveland, Ohio, United States, 44111
      • Recruiting
      • Research Site
    • Cleveland, Ohio, United States, 44124
      • Recruiting
      • Research Site
    • Columbus, Ohio, United States, 43219
      • Recruiting
      • Research Site
  • Oregon
    • Portland, Oregon, United States, 97223
      • Recruiting
      • Research Site
    • Portland, Oregon, United States, 97227
      • Recruiting
      • Research Site
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Recruiting
      • Research Site
    • Harrisburg, Pennsylvania, United States, 17101
      • Recruiting
      • Research Site
    • Hershey, Pennsylvania, United States, 17033
      • Recruiting
      • Research Site
    • Meadville, Pennsylvania, United States, 16335
      • Not yet recruiting
      • Research Site
    • Philadelphia, Pennsylvania, United States, 19111
      • Recruiting
      • Research Site
    • Philadelphia, Pennsylvania, United States, 19104
      • Withdrawn
      • Research Site
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • Research Site
    • Pittsburgh, Pennsylvania, United States, 15212
      • Recruiting
      • Research Site
    • York, Pennsylvania, United States, 17403
      • Recruiting
      • Research Site
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • Research Site
  • South Carolina
    • West Columbia, South Carolina, United States, 29169
      • Not yet recruiting
      • Research Site
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Recruiting
      • Research Site
    • Germantown, Tennessee, United States, 38138
      • Recruiting
      • Research Site
    • Knoxville, Tennessee, United States, 37916
      • Recruiting
      • Research Site
    • Memphis, Tennessee, United States, 38120
      • Recruiting
      • Research Site
    • Nashville, Tennessee, United States, 37232
      • Not yet recruiting
      • Research Site
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Research Site
  • Texas
    • Bedford, Texas, United States, 76022
      • Recruiting
      • Research Site
    • Dallas, Texas, United States, 75246
      • Recruiting
      • Research Site
    • Dallas, Texas, United States, 75230
      • Recruiting
      • Research Site
    • Dallas, Texas, United States, 75251
      • Not yet recruiting
      • Research Site
    • Denton, Texas, United States, 76201
      • Recruiting
      • Research Site
    • El Paso, Texas, United States, 79915
      • Withdrawn
      • Research Site
    • Fort Worth, Texas, United States, 76104
      • Recruiting
      • Research Site
    • Fort Worth, Texas, United States, 76177
      • Recruiting
      • Research Site
    • Houston, Texas, United States, 77030
      • Recruiting
      • Research Site
    • Houston, Texas, United States, 77030
      • Not yet recruiting
      • Research Site
    • Houston, Texas, United States, 77024
      • Recruiting
      • Research Site
    • Lubbock, Texas, United States, 79430
      • Withdrawn
      • Research Site
    • McAllen, Texas, United States, 78503
      • Recruiting
      • Research Site
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • Research Site
    • Gainesville, Virginia, United States, 20155
      • Withdrawn
      • Research Site
    • Gainesville, Virginia, United States, 20155
      • Recruiting
      • Research Site
    • Midlothian, Virginia, United States, 23114
      • Recruiting
      • Research Site
    • Norfolk, Virginia, United States, 23502
      • Recruiting
      • Research Site
    • Roanoke, Virginia, United States, 24014
      • Recruiting
      • Research Site
  • Washington
    • Edmonds, Washington, United States, 98026
      • Recruiting
      • Research Site
    • Issaquah, Washington, United States, 98029
      • Recruiting
      • Research Site
    • Kennewick, Washington, United States, 99336
      • Recruiting
      • Research Site
    • Puyallup, Washington, United States, 98373
      • Recruiting
      • Research Site
    • Seattle, Washington, United States, 98104
      • Recruiting
      • Research Site
    • Seattle, Washington, United States, 98133
      • Recruiting
      • Research Site
    • Spokane Valley, Washington, United States, 99216
      • Recruiting
      • Research Site
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • Recruiting
      • Research Site
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Withdrawn
      • Research Site
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participant must be ≥ 18 years at the time of screening.
2. Histologically confirmed invasive TNBC, as defined by the ASCO/CAP guidelines.
3. Residual invasive disease in the breast and/or axillary lymph node(s) at surgical resection following neoadjuvant therapy.
4. Completed at least 6 cycles of neoadjuvant therapy containing an anthracycline and/or a taxane with or without platinum chemotherapy, with or without pembrolizumab.
5. No evidence of locoregional or distant relapse.
6. Surgical removal of all clinically evident disease in the breast and lymph nodes.
7. ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to randomisation.
8. All participants must provide an FFPE tumour sample from residual invasive disease at surgery for tissue-based analysis.
9. No adjuvant systemic therapy.
10. Radiotherapy (if indicated) delivered before the start of study intervention.
11. If post-operative radiation therapy is given, an interval of no more than 6 weeks between the completion of radiation therapy and the date of randomisation (radiation therapy can be completed during screening period). If no post-operative radiation therapy is given, an interval of no more than 16 weeks between the date of breast surgery and the date of randomisation.
12. Has LVEF ≥ 50% by either an ECHO or MUGA scan within 28 days before randomisation.
13. Eligible for one of the therapy options listed as investigator's choice per investigator assessment.
14. No known germline BRCA1 or BRCA2 pathogenic mutation.
15. Adequate bone marrow reserve and organ function within 7 days before randomisation.

Exclusion Criteria:

1. Stage IV (metastatic) TNBC.
2. History of prior invasive breast cancer, or evidence of recurrent disease following preoperative therapy and surgery.
3. Severe or uncontrolled medical conditions including systemic diseases, history of allogeneic organ transplant and active bleeding diseases, ongoing or active infection, serious chronic gastrointestinal conditions associated with diarrhea chronic diverticulitis or previous complicated diverticulitis.
4. History of another primary malignancy except for adequately resected basal cell carcinoma of the skin or squamous cell carcinoma of the skin, in situ disease (including ductal carcinoma in situ) that has undergone potentially curative therapy, or other solid malignancy treated with curative intent with no known active disease within 5 years before randomisation and of low potential risk for recurrence.
5. Persistent toxicities caused by previous anticancer therapy, excluding alopecia, not yet improved to Grade ≤ 1 or baseline. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention may be included (eg, hearing loss).
6. Active or prior documented autoimmune or inflammatory disorders.
7. Clinically significant corneal disease.
8. Active or uncontrolled hepatitis B or C virus infection.
9. Known HIV infection that is not well controlled
10. Active tuberculosis infection.
11. Mean resting corrected QTcF > 470 ms regardless of gender, obtained from triplicate 12-lead ECGs performed at screening.
12. Uncontrolled or significant cardiac disease.
13. History of non-infectious ILD/pneumonitis including radiation, pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
14. Has severe pulmonary function compromise.
15. Any known active liver disease.
16. Grade ≥ 2 peripheral neuropathy of any aetiology.
17. Prior exposure to a PD-1/PD-L1 inhibitor other than pembrolizumab.
18. Current or prior use of immunosuppressive medication within 14 days prior to randomisation.
19. Participants with a known severe hypersensitivity to Dato-DXd or any of the excipients of these products including but not limited to polysorbate 80 or other monoclonal antibodies.
20. Participants with a known severe hypersensitivity to PD-1/PD-L1 inhibitors.
21. Participation in another clinical study with a study intervention or investigational medicinal device administered in the last 4 weeks prior to randomisation, randomisation into a prior Dato-DXd, T-DXd, or durvalumab study regardless of treatment assignment.
22. Currently pregnant (confirmed with positive pregnancy test), breastfeeding or planning to become pregnant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dato-DXd in combination with Durvalumab; Arm 1: Dato-DXd 6 mg/kg IV Q3W x 8 cycles + Durvalumab 1120 mg IV Q3W x 9 cycles	Drug: Dato-DXd; Experimental drug. Provided in 100mg vials. IV infusion; Other Names: Datopotamab deruxtecan (Dato-DXd, DS-1062a); Drug: Durvalumab; Experimental drug. Provided in 50mg vials. IV infusion; Other Names: MEDI4736
Experimental: Dato-DXd; Arm 2: Dato-DXd 6 mg/kg IV Q3W x 8 cycles	Drug: Dato-DXd; Experimental drug. Provided in 100mg vials. IV infusion; Other Names: Datopotamab deruxtecan (Dato-DXd, DS-1062a)
Active Comparator: Investigators Choice Therapy; Arm 3: Capecitabine (1000 or 1250 mg/m2 oral BID on Days 1 to 14, Q3W) for 8 cycles Pembrolizumab* (200 mg IV on Day 1, Q3W) for 9 cycles Capecitabine (1000 or 1250 mg/m2 oral BID on Days 1 to 14, Q3W) for 8 cycles + pembrolizumab* (200 mg IV on Day 1, Q3W) for 9 cycles * Only participants who have received prior pembrolizumab in the neoadjuvant setting should receive pembrolizumab as part of their adjuvant therapy on Arm 3.	Drug: Capecitabine; Active Comparator. Tablet. Oral route of administration; Other Names: XELODA®, Capecitabine Cell Pharm, Capecitabine EG, Capecitabine Accord; Drug: Pembrolizumab; Active Comparator. Provided in 100mg vials. IV infusion; Other Names: KEYTRUDA®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Invasive disease-free survival (iDFS) for Dato-DXd + durvalumab vs. ICT	iDFS is defined as time from randomisation until date of first occurrence of one of the following events: ipsilateral invasive breast tumour (local) recurrence, regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and skin of ipsilateral breast), or distant recurrence (metastatic breast cancer that has either been biopsy-confirmed or clinically diagnosed as recurrent invasive breast cancer); contralateral invasive breast cancer; second primary non-breast invasive cancer (other than squamous or basal cell skin cancer); or death from any cause. iDFS will be determined based on disease recurrence per investigator assessment based on all available clinical assessments. The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy or receives another anticancer therapy. The measure of interest will be the HR (hazard ratio) of iDFS for Dato-DXd + durvalumab vs ICT.	From randomisation to date of the event, up to 57 months from first subject in

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics of Dato-DXd	Concentration of Dato- DXd, total anti-TROP2 antibody, and MAAA-1181 in plasma.	Day 1 of cycles 1,2,4,6,8 (Each cycle is 21 days)
Immunogenicity of Dato-DXd	Presence of ADAs for Dato-DXd (confirmatory results: positive or negative; titres).	Day 1 of cycles 1,2,4,6,8 (Each cycle is 21 days) and within 35 days of completion of or discontinuation of study intervention (at an average of 6 months following randomization)
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)	Safety and tolerability will be evaluated in terms of AEs (graded by CTCAE version 5.0).	Randomization to final safety follow-up visit, either 90 days after last dose of study intervention for those who complete planned study intervention or 90 days after date of discontinuation for those who discontinue study intervention prematurely
Distant disease-free survival (DDFS) for Dato-DXd + durvalumab vs ICT	DDFS is defined as time from randomisation to date of first distant recurrence, occurrence of second primary non-breast invasive cancer, or death from any cause. DDFS is determined based on disease recurrence per investigators assessment based on all available clinical assessments. The analysis will include all randomised participants, as randomised regardless of whether the participant withdraws from randomised therapy or received another anticancer therapy. The measure of interest will be the HR (hazard ratio) of DDFS for Dato-DXd + durvalumab vs ICT.	From randomisation to date of the event, up to 57 months from first subject in
DDFS for Dato-DXd vs ICT	DDFS is defined as time from randomisation to date of first distant recurrence, occurrence of second primary non-breast invasive cancer, or death from any cause. DDFS is determined based on disease recurrence per investigators assessment based on all available clinical assessments. The measure of interest will be the HR (hazard ratio) of DDFS for Dato-DXd vs ICT.	From randomisation to date of the event, up to 57 months from first subject in
DDFS for Dato-DXd + durvalumab vs Dato-DXd	DDFS is defined as time from randomisation to date of first distant recurrence, occurrence of second primary non-breast invasive cancer, or death from any cause. DDFS is determined based on disease recurrence per investigators assessment based on all available clinical assessments. The measure of interest will be the HR (hazard ratio) of DDFS for Dato-DXd + durvalumab vs Dato-DXd.	From randomisation to date of the event, up 57 months from first subject in
Overall Survival (OS) for Dato-DXd + durvalumab vs ICT	OS is defined as time from randomisation until date of death due to any cause. The analysis will include all randomised participants, as randomised regardless of whether the participant withdraws from randomised therapy or received another anticancer therapy. The measure of interest will be the HR (hazard ratio) of OS for Dato-DXd + durvalumab vs ICT.	From randomisation to date of death, due to any cause, up to 87 months from first subject in
OS for Dato-DXd vs ICT	OS is defined as time from randomisation until date of death due to any cause. The measure of interest will be the HR (hazard ratio) of OS for Dato-DXd vs ICT.	From randomisation to date of death, due to any cause, up to 87 months from first subject in
iDFS for Dato-DXd vs ICT	iDFS is defined as time from randomisation until date of first occurrence of one of the following events: ipsilateral invasive breast tumour (local) recurrence, regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and skin of ipsilateral breast), or distant recurrence (metastatic breast cancer that has either been biopsy-confirmed or clinically diagnosed as recurrent invasive breast cancer); contralateral invasive breast cancer; second primary non-breast invasive cancer (other than squamous or basal cell skin cancer); or death from any cause. iDFS will be determined based on disease recurrence per investigator assessment based on all available clinical assessments. The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy or receives another anticancer therapy. The measure of interest will be the HR (hazard ratio) of iDFS for Dato-DXd vs ICT.	From randomisation to date of the event, up to 57 months from first subject in
iDFS for Dato-DXd + durvalumab vs Dato-DXd	iDFS is defined as time from randomisation until date of first occurrence of one of the following events: ipsilateral invasive breast tumour (local) recurrence, regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and skin of ipsilateral breast), or distant recurrence (metastatic breast cancer that has either been biopsy-confirmed or clinically diagnosed as recurrent invasive breast cancer); contralateral invasive breast cancer; second primary non-breast invasive cancer (other than squamous or basal cell skin cancer); or death from any cause. The measure of interest will be the HR (hazard ratio) of iDFS for Dato-DXd + durvalumab vs Dato-DXd.	From randomisation to date of the event, up to 57 months from first subject in
Participant-reported physical function in participants treated with Dato-DXd with or without durvalumab compared with ICT	Time to Deterioration (TTD) and actual scores in physical function as measured by the PROMIS Physical Function Short Form 8c.TTD is defined as time from the date of randomisation to the date of deterioration. Deterioration is defined as change from baseline that reaches a clinically meaningful deterioration threshold. The analysis will include all dosed participants. The measure of interest is the HR (hazard ratio) of TTD and mean between-arm difference in physical function for Dato-DXd with or without durvalumab compared with ICT.	From randomisation to date of the deterioration, up to 36 months after randomisation
Participant-reported in GHS/QoL in participants treated with Dato-DXd with or without durvalumab compared with ICT	Time to Deterioration (TTD) and actual scores in GHS/QoL as measured by the GHS/QoL scale from the EORTC IL172. TTD is defined as time from the date of randomisation to the date of deterioration. Deterioration is defined as change from baseline that reaches a clinically meaningful deterioration threshold. The analysis will include all randomised participants. The measure of interest is the HR (hazard ratio) of TTD and mean between-arm difference in GHS/QoL for Dato-DXd with or without durvalumab compared with ICT.	From randomisation to date of the deterioration, up to 36 months after randomisation
Participant-reported fatigue in participants treated with Dato-DXd with or without durvalumab compared with ICT	Proportion of participants experiencing different levels of fatigue at 3 months (13weeks), 6 months (26 weeks), and 12 months (52 weeks) as measured by PROMIS Fatigue Short Form 7a. The analysis will include all dosed participants. The measure of interest will be the proportion of participants reporting different levels of fatigue.	From randomisation to 24 months after randomisation

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: SWOG Clinical Trials Partnerships; Daiichi Sankyo
• Investigators: Study Chair: Aditya Bardia, MD, MPH, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2022
• Primary Completion (Estimated): September 20, 2027
• Study Completion (Estimated): March 27, 2030

Study Registration Dates

• First Submitted: November 4, 2022
• First Submitted That Met QC Criteria: November 17, 2022
• First Posted (Actual): November 29, 2022

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Breast Cancer; TNBC; Adjuvant; Durvalumab; Triple-negative; Datopotamab Deruxtecan; Dato-DXd; DS1062a; Antibody Drug Conjugate; ADC; TROP2
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Capecitabine; Durvalumab; Pembrolizumab
• Other Study ID Numbers: D926XC00001; 2022-002680-30 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No