A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer

A Phase III, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy (Paclitaxel, Nab-paclitaxel or Gemcitabine + Carboplatin) in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05)

This is a Phase III, randomised, open-label, 3-arm, multicentre, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with investigator's choice chemotherapy in combination with pembrolizumab in participants with PD-L1 positive locally recurrent inoperable or metastatic TNBC.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Dato-DXd; Drug: Durvalumab; Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Gemcitabine; Drug: Carboplatin; Drug: Pembrolizumab

Detailed Description

The primary objective of the study is to demonstrate superiority of Dato-DXd + durvalumab relative to ICC + pembrolizumab by assessment of PFS as assessed by BICR in participants with PD-L1 positive locally recurrent inoperable or metastatic TNBC.

The study will be stratified based on geographic location (US/Canada/Europe vs. Dato-DXd monotherapy enrolling countries vs. rest of world), disease-free interval (DFI) history (de novo vs. prior DFI 6 to 12 months vs. prior DFI > 12 months), and prior PD-1/PD-L1 treatment for early stage TNBC (yes vs. no).

This study aims to see if Dato-DXd with durvalumab allows patients to live longer without their breast cancer getting worse, or simply to live longer, compared to patients receiving standard of care chemotherapy and pembrolizumab. This study is also looking to see how the treatment and the breast cancer affects patients' quality of life.

• Study Type: Interventional
• Enrollment (Estimated): 625
• 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 Contact Backup: Name: AstraZeneca Breast Cancer Study Locator Service; Phone Number: +1-877-400-4656; Email: az-bcsl@careboxhealth.com

Study Locations

• Argentina
  • CABA, Argentina, 1425
    • Recruiting
    • Research Site
  • CABA, Argentina, 1414
    • Recruiting
    • Research Site
  • CABA, Argentina, C1425
    • Withdrawn
    • Research Site
  • CABA, Argentina, C1113AAE
    • Recruiting
    • Research Site
  • Ciudad Autónoma Buenos Aires, Argentina, C1430EFA
    • Recruiting
    • Research Site
  • Ciudad de Buenos Aires, Argentina, C1015ABO
    • Recruiting
    • Research Site
  • Rosario, Argentina, 2000
    • Recruiting
    • Research Site
  • San Nicolás de los Arroyos, Argentina, B2900
    • Withdrawn
    • Research Site
• Australia
  • Camperdown, Australia, 2050
    • Recruiting
    • Research Site
  • Darlinghurst, Australia, 2010
    • Completed
    • Research Site
  • Heidelberg, Australia, 3084
    • Completed
    • Research Site
  • Melbourne, Australia, 3000
    • Recruiting
    • Research Site
  • Nedlands, Australia, 6009
    • Recruiting
    • Research Site
  • Waratah, Australia, 2298
    • Withdrawn
    • Research Site
• Brazil
  • Barretos, Brazil, 14784-400
    • Recruiting
    • Research Site
  • Curitiba, Brazil, 80730-150
    • Recruiting
    • Research Site
  • Florianópolis, Brazil, 88034-000
    • Recruiting
    • Research Site
  • Goiânia, Brazil, 74000-000
    • Recruiting
    • Research Site
  • Itajaí, Brazil, 88301-220
    • Recruiting
    • Research Site
  • Porto Alegre, Brazil, 90035-003
    • Recruiting
    • Research Site
  • Recife, Brazil, 52010-075
    • Recruiting
    • Research Site
  • São Paulo, Brazil, 01246-000
    • Recruiting
    • Research Site
  • São Paulo, Brazil, 01317-001
    • Recruiting
    • Research Site
  • Teresina, Brazil, 64049-200
    • Recruiting
    • Research Site
• Canada
  • Ontario
    • Barrie, Ontario, Canada, L4M 6M2
      • Recruiting
      • Research Site
    • Hamilton, Ontario, Canada, L8V 5C2
      • Recruiting
      • Research Site
    • Toronto, Ontario, Canada, M5G 2M9
      • Recruiting
      • Research Site
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • Recruiting
      • Research Site
    • Montreal, Quebec, Canada, H4A 3J1
      • Recruiting
      • Research Site
    • Montreal, Quebec, Canada, H2X 0A9
      • Recruiting
      • Research Site
    • Québec, Quebec, Canada, G1S 4L8
      • Recruiting
      • Research Site
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4T 7T1
      • Recruiting
      • Research Site
    • Saskatoon, Saskatchewan, Canada, S7N 4H4
      • Recruiting
      • Research Site
• China
  • Anyang, China, 455000
    • Recruiting
    • Research Site
  • Beijing, China, 100044
    • Recruiting
    • Research Site
  • Beijing, China, 100142
    • Recruiting
    • Research Site
  • Bengbu, China, 233004
    • Recruiting
    • Research Site
  • Changchun, China, 130021
    • Recruiting
    • Research Site
  • Changsha, China, 410008
    • Recruiting
    • Research Site
  • Changsha, China, 410013
    • Recruiting
    • Research Site
  • Chengdu, China, 610000
    • Recruiting
    • Research Site
  • Chengdu, China, 610041
    • Recruiting
    • Research Site
  • Chongqing, China, 400030
    • Withdrawn
    • Research Site
  • Fuzhou, China, 350014
    • Recruiting
    • Research Site
  • Guangzhou, China, 510120
    • Recruiting
    • Research Site
  • Guangzhou, China, 510060
    • Recruiting
    • Research Site
  • Guangzhou, China, 510700
    • Recruiting
    • Research Site
  • Hangzhou, China, 310009
    • Recruiting
    • Research Site
  • Hangzhou, China, 310022
    • Recruiting
    • Research Site
  • Hangzhou, China, 310016
    • Recruiting
    • Research Site
  • Harbin, China, 150081
    • Recruiting
    • Research Site
  • Hefei, China, 230031
    • Recruiting
    • Research Site
  • Jinan, China, 250021
    • Recruiting
    • Research Site
  • Meizhou, China, 514031
    • Not yet recruiting
    • Research Site
  • Nanchang, China, 330009
    • Recruiting
    • Research Site
  • Nanjing, China, 210009
    • Recruiting
    • Research Site
  • Nanjing, China, 2100008
    • Recruiting
    • Research Site
  • Nanning, China, 530021
    • Recruiting
    • Research Site
  • Shandong, China
    • Recruiting
    • Research Site
  • Shanghai, China, 200025
    • Recruiting
    • Research Site
  • Shanghai, China, 200080
    • Completed
    • Research Site
  • Shenyang, China, 110004
    • Recruiting
    • Research Site
  • Tianjin, China, 300000
    • Recruiting
    • Research Site
  • Wenzhou, China, 325000
    • Recruiting
    • Research Site
  • Wuhan, China, 430022
    • Recruiting
    • Research Site
  • Wuhan, China, 430079
    • Recruiting
    • Research Site
  • Xi'an, China, 710061
    • Recruiting
    • Research Site
  • Xiamen, China, 361003
    • Recruiting
    • Research Site
  • Xintai, China, 54031
    • Recruiting
    • Research Site
  • Xuzhou, China, 221009
    • Recruiting
    • Research Site
  • Zhanjiang, China, 524003
    • Recruiting
    • Research Site
  • Zhengzhou, China, 450008
    • Recruiting
    • Research Site
  • Zhengzhou, China, 450052
    • Recruiting
    • Research Site
• France
  • Lille, France, 59000
    • Recruiting
    • Research Site
  • Lyon, France, 69373
    • Recruiting
    • Research Site
  • Montpellier, France, 34298
    • Recruiting
    • Research Site
  • Paris, France, 75020
    • Recruiting
    • Research Site
  • Saint-Herblain, France, 44805
    • Recruiting
    • Research Site
  • Toulouse, France, 31059
    • Recruiting
    • Research Site
  • Vandœuvre-lès-Nancy, France, 54511
    • Recruiting
    • Research Site
  • Villejuif, France, 94800
    • Recruiting
    • Research Site
• Germany
  • Düsseldorf, Germany, 40479
    • Withdrawn
    • Research Site
  • Essen, Germany, 45136
    • Withdrawn
    • Research Site
  • Georgsmarienhütte, Germany, 49124
    • Withdrawn
    • Research Site
  • Hamburg, Germany, 20357
    • Withdrawn
    • Research Site
  • Hanover, Germany, 30625
    • Withdrawn
    • Research Site
  • Heidelberg, Germany, 69120
    • Withdrawn
    • Research Site
  • Heilbronn, Germany, 74078
    • Withdrawn
    • Research Site
  • Leipzig, Germany, 04103
    • Withdrawn
    • Research Site
• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Research Site
  • Hong Kong, Hong Kong, 999077
    • Not yet recruiting
    • Research Site
  • Hong Kong, Hong Kong, 999077
    • Recruiting
    • Research Site
  • Shatin, Hong Kong, 00000
    • Recruiting
    • Research Site
• India
  • Calicut, India, 673601
    • Withdrawn
    • Research Site
  • Chennai, India, 600031
    • Recruiting
    • Research Site
  • Jaipur, India, 302004
    • Not yet recruiting
    • Research Site
  • Kochi, India, 682027
    • Withdrawn
    • Research Site
  • Kolkata, India, 700160
    • Withdrawn
    • Research Site
  • Marg Jaipur, India, 302004
    • Recruiting
    • Research Site
  • Mohali, India, 160055
    • Recruiting
    • Research Site
  • Mysuru, India, 570017
    • Recruiting
    • Research Site
  • Nagpur, India, 440001
    • Recruiting
    • Research Site
  • Nashik, India, 422009
    • Recruiting
    • Research Site
  • New Delhi, India, 11029
    • Recruiting
    • Research Site
  • New Delhi, India, 110075
    • Recruiting
    • Research Site
  • Puducherry, India, 605006
    • Recruiting
    • Research Site
  • Surat, India, 395002
    • Recruiting
    • Research Site
  • Thiruvananthapuram, India, 695011
    • Recruiting
    • Research Site
  • Vadodara, India, 391760
    • Recruiting
    • Research Site
  • Visakhapatnam, India, 530053
    • Withdrawn
    • Research Site
• Italy
  • Bergamo, Italy, 24127
    • Recruiting
    • Research Site
  • Empoli, Italy, 50053
    • Recruiting
    • Research Site
  • Milan, Italy, 20132
    • Recruiting
    • Research Site
  • Milan, Italy, 20141
    • Recruiting
    • Research Site
  • Modena, Italy, 41124
    • Withdrawn
    • Research Site
  • Naples, Italy, 80131
    • Recruiting
    • Research Site
  • Padova, Italy, 35128
    • Recruiting
    • Research Site
  • Reggio Emilia, Italy, 42123
    • Recruiting
    • Research Site
  • Roma, Italy, 00168
    • Recruiting
    • Research Site
  • Rozzano, Italy, 20089
    • Recruiting
    • Research Site
• Japan
  • Akashi-shi, Japan, 673-8558
    • Recruiting
    • Research Site
  • Bunkyō City, Japan, 113-8431
    • Recruiting
    • Research Site
  • Bunkyō City, Japan, 113-8677
    • Recruiting
    • Research Site
  • Chiba, Japan, 260-8717
    • Recruiting
    • Research Site
  • Chūōku, Japan, 104-0045
    • Recruiting
    • Research Site
  • Fukuoka, Japan, 811-1395
    • Recruiting
    • Research Site
  • Fukushima, Japan, 960-1295
    • Recruiting
    • Research Site
  • Gifu, Japan, 501-1194
    • Recruiting
    • Research Site
  • Hidaka-shi, Japan, 350-1298
    • Recruiting
    • Research Site
  • Hiroshima, Japan, 734-8551
    • Recruiting
    • Research Site
  • Hiroshima, Japan, 730-8518
    • Recruiting
    • Research Site
  • Isehara-shi, Japan, 259-1193
    • Recruiting
    • Research Site
  • Kamogawa-shi, Japan, 296-8602
    • Recruiting
    • Research Site
  • Kashiwa, Japan, 277-8577
    • Recruiting
    • Research Site
  • Kitaadachi-gun, Japan, 362-0806
    • Recruiting
    • Research Site
  • Kumamoto, Japan, 860-8556
    • Recruiting
    • Research Site
  • Kurume-shi, Japan, 830-0011
    • Recruiting
    • Research Site
  • Kōtoku, Japan, 135-8550
    • Recruiting
    • Research Site
  • Matsuyama, Japan, 791-0280
    • Recruiting
    • Research Site
  • Nagoya, Japan, 466-8560
    • Recruiting
    • Research Site
  • Nagoya, Japan, 467-8602
    • Recruiting
    • Research Site
  • Niigata, Japan, 951-8566
    • Recruiting
    • Research Site
  • Nishinomiya-shi, Japan, 663-8501
    • Recruiting
    • Research Site
  • Okayama, Japan, 700-8558
    • Recruiting
    • Research Site
  • Osaka, Japan, 541-8567
    • Recruiting
    • Research Site
  • Osakasayama-shi, Japan, 589-8511
    • Recruiting
    • Research Site
  • Ota-shi, Japan, 373-8550
    • Recruiting
    • Research Site
  • Sapporo, Japan, 003-0804
    • Recruiting
    • Research Site
  • Sendai, Japan, 980-8574
    • Recruiting
    • Research Site
  • Shinagawa-ku, Japan, 142-8666
    • Recruiting
    • Research Site
  • Shinjuku-ku, Japan, 162-8655
    • Recruiting
    • Research Site
  • Shinjuku-ku, Japan, 160-0023
    • Recruiting
    • Research Site
  • Tsu, Japan, 514-8507
    • Recruiting
    • Research Site
  • Tsukuba, Japan, 305-8577
    • Recruiting
    • Research Site
  • Yokohama, Japan, 241-8515
    • Recruiting
    • Research Site
• Mexico
  • CD Mexico, Mexico, 04980
    • Recruiting
    • Research Site
  • Guadalajara, Mexico, 44670
    • Withdrawn
    • Research Site
  • Guadalajara, Mexico, 44638
    • Recruiting
    • Research Site
  • Mexico City, Mexico, 0 3100
    • Recruiting
    • Research Site
  • México, Mexico, 04700
    • Recruiting
    • Research Site
  • México, Mexico, 6760
    • Recruiting
    • Research Site
  • Tuxtla Gutiérrez, Mexico, 29090
    • Recruiting
    • Research Site
• Philippines
  • Bacolod, Philippines, 6100
    • Recruiting
    • Research Site
  • Cebu City, Philippines, 6000
    • Recruiting
    • Research Site
  • City of Muntinlupa, Philippines, 1780
    • Recruiting
    • Research Site
  • Manila, Philippines, 1000
    • Recruiting
    • Research Site
  • Quezon City, Philippines, 1112
    • Recruiting
    • Research Site
  • San Juan City, Philippines, 1502
    • Recruiting
    • Research Site
• Poland
  • Bialystok, Poland, 15-027
    • Withdrawn
    • Research Site
  • Bydgoszcz, Poland, 85-796
    • Withdrawn
    • Research Site
  • Gdansk, Poland, 80-952
    • Recruiting
    • Research Site
  • Gdynia, Poland, 81-519
    • Withdrawn
    • Research Site
  • Konin, Poland, 62-500
    • Withdrawn
    • Research Site
  • Krakow, Poland, 31-501
    • Recruiting
    • Research Site
  • Krakow, Poland, 31-115
    • Withdrawn
    • Research Site
  • Legnica, Poland, 59-220
    • Withdrawn
    • Research Site
  • Lodz, Poland, 90-302
    • Recruiting
    • Research Site
  • Lublin, Poland, 20-090
    • Withdrawn
    • Research Site
  • Przemyśl, Poland, 37-700
    • Withdrawn
    • Research Site
  • Warsaw, Poland, 02-781
    • Recruiting
    • Research Site
  • Wroclaw, Poland, 53-413
    • Withdrawn
    • Research Site
• Singapore
  • Singapore, Singapore, 169610
    • Recruiting
    • Research Site
  • Singapore, Singapore, 308433
    • Recruiting
    • Research Site
  • Singapore, Singapore, 217562
    • Recruiting
    • Research Site
  • Singapore, Singapore, 119228
    • Withdrawn
    • Research Site
• South Africa
  • Cape Town, South Africa, 7570
    • Recruiting
    • Research Site
  • Johannesburg, South Africa, 2013
    • Recruiting
    • Research Site
  • Johannesburg, South Africa, 2196
    • Recruiting
    • Research Site
  • Johannesburg, South Africa, 2193
    • Recruiting
    • Research Site
  • Paarl, South Africa, 7646
    • Recruiting
    • Research Site
  • Pretoria, South Africa, 0081
    • Recruiting
    • Research Site
  • Pretoria, South Africa, 0081
    • Active, not recruiting
    • Research Site
• South Korea
  • Busan, South Korea, 49241
    • Completed
    • Research Site
  • Daegu, South Korea, 41404
    • Recruiting
    • Research Site
  • Goyang-si, South Korea, 10408
    • Recruiting
    • Research Site
  • Seongnam-si, South Korea, 13620
    • Recruiting
    • Research Site
  • Seoul, South Korea, 03080
    • Recruiting
    • Research Site
  • Seoul, South Korea, 06351
    • Recruiting
    • Research Site
  • Seoul, South Korea, 05505
    • Recruiting
    • Research Site
  • Seoul, South Korea, 03722
    • Recruiting
    • Research Site
  • Seoul, South Korea, 06591
    • Recruiting
    • Research Site
  • Seoul, South Korea, 02841
    • Recruiting
    • Research Site
  • Seoul, South Korea, 06273
    • Recruiting
    • Research Site
• Spain
  • Barcelona, Spain, 8035
    • Recruiting
    • Research Site
  • Barcelona, Spain, 08028
    • Withdrawn
    • Research Site
  • Granada, Spain, 18016
    • Recruiting
    • Research Site
  • Hospitalet deLlobregat, Spain, 08907
    • Recruiting
    • Research Site
  • Madrid, Spain, 28007
    • Recruiting
    • Research Site
  • Madrid, Spain, 28034
    • Withdrawn
    • Research Site
  • Pamplona, Spain, 31008
    • Recruiting
    • Research Site
  • Santander, Spain, 39008
    • Recruiting
    • Research Site
• Taiwan
  • Hsinchu, Taiwan, 300
    • Recruiting
    • Research Site
  • Kaohsiung City, Taiwan, 80756
    • Recruiting
    • Research Site
  • Taichung, Taiwan, 40447
    • Recruiting
    • Research Site
  • Tainan, Taiwan, 704
    • Recruiting
    • Research Site
  • Taipei, Taiwan, 100
    • Recruiting
    • Research Site
  • Taipei, Taiwan, 112
    • Recruiting
    • Research Site
  • Taipei, Taiwan, 10449
    • Recruiting
    • Research Site
  • Taipei, Taiwan, 11259
    • Recruiting
    • Research Site
  • Taoyuan, Taiwan, 333
    • Recruiting
    • Research Site
• Thailand
  • Bangkok, Thailand, 10210
    • Recruiting
    • Research Site
  • Bangkok, Thailand, 10400
    • Recruiting
    • Research Site
  • Bangkok, Thailand, 10700
    • Not yet recruiting
    • Research Site
  • Bangkok, Thailand, 10330
    • Recruiting
    • Research Site
  • Chiang Mai, Thailand, 50200
    • Recruiting
    • Research Site
  • Dusit, Thailand, 10300
    • Recruiting
    • Research Site
  • Khon Kaen, Thailand, 40002
    • Recruiting
    • Research Site
  • Songkhla, Thailand, 90110
    • Recruiting
    • Research Site
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 6200
    • Recruiting
    • Research Site
  • Ankara, Turkey (Türkiye), 06520
    • Recruiting
    • Research Site
  • Besevler Ankara, Turkey (Türkiye)
    • Recruiting
    • Research Site
  • Istanbul, Turkey (Türkiye), 34010
    • Recruiting
    • Research Site
  • Izmir, Turkey (Türkiye), 35575
    • Withdrawn
    • Research Site
  • Küçükçekmece, Turkey (Türkiye), 34295
    • Recruiting
    • Research Site
  • Samsun, Turkey (Türkiye), 55200
    • Recruiting
    • Research Site
• United Kingdom
  • Cardiff, United Kingdom, CF14 2TL
    • Recruiting
    • Research Site
  • Chelsea, United Kingdom, SW3 6JJ
    • Recruiting
    • Research Site
  • Leicester, United Kingdom, Le5 4PW
    • Recruiting
    • Research Site
  • Liverpool, United Kingdom, L7 8YA
    • Terminated
    • Research Site
  • London, United Kingdom, EC1A 7BE
    • Recruiting
    • Research Site
  • London, United Kingdom, SW17 0QT
    • Withdrawn
    • Research Site
  • Oxford, United Kingdom, OX3 7LE
    • Suspended
    • Research Site
  • Surrey, United Kingdom, GU2 7XX
    • Suspended
    • Research Site
  • Sutton, United Kingdom, SM2 5PT
    • Recruiting
    • Research Site
  • Taunton, United Kingdom, TA1 5DA
    • Recruiting
    • Research Site
• United States
  • Alabama
    • Daphne, Alabama, United States, 36526
      • Recruiting
      • Research Site
  • Arkansas
    • Springdale, Arkansas, United States, 72762
      • Recruiting
      • Research Site
  • California
    • Duarte, California, United States, 91010
      • Withdrawn
      • Research Site
    • Glendale, California, United States, 91204
      • Recruiting
      • Research Site
    • Sacramento, California, United States, 95817
      • Recruiting
      • Research Site
    • Santa Rosa, California, United States, 95403
      • Withdrawn
      • Research Site
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Recruiting
      • Research Site
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Research Site
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Withdrawn
      • Research Site
    • Miami, Florida, United States, 33176
      • Recruiting
      • Research Site
    • Palm Bay, Florida, United States, 32909
      • Withdrawn
      • Research Site
    • Plantation, Florida, United States, 33324
      • Recruiting
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Suspended
      • Research Site
  • Hawaii
    • Honolulu, Hawaii, United States, 96819
      • Withdrawn
      • Research Site
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • Research Site
    • Decatur, Illinois, United States, 62526
      • Withdrawn
      • Research Site
    • Elmhurst, Illinois, United States, 60126
      • Withdrawn
      • Research Site
    • Naperville, Illinois, United States, 60540
      • Withdrawn
      • Research Site
  • Indiana
    • New Albany, Indiana, United States, 47150
      • Withdrawn
      • Research Site
  • Iowa
    • Des Moines, Iowa, United States, 50309
      • Recruiting
      • Research Site
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Withdrawn
      • Research Site
    • Louisville, Kentucky, United States, 40202
      • Withdrawn
      • Research Site
    • Louisville, Kentucky, United States, 40207
      • Withdrawn
      • Research Site
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Recruiting
      • Research Site
    • Baton Rouge, Louisiana, United States, 70808
      • Withdrawn
      • Research Site
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Withdrawn
      • Research Site
    • Columbia, Maryland, United States, 21044
      • Recruiting
      • Research Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Withdrawn
      • Research Site
    • Worcester, Massachusetts, United States, 01655
      • Withdrawn
      • Research Site
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Research Site
    • Grand Rapids, Michigan, United States, 49503
      • Withdrawn
      • Research Site
  • Minnesota
    • Saint Paul, Minnesota, United States, 55109
      • Recruiting
      • Research Site
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Withdrawn
      • Research Site
  • Missouri
    • St Louis, Missouri, United States, 63129
      • Recruiting
      • Research Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Recruiting
      • Research Site
  • New York
    • Albany, New York, United States, 12206
      • Withdrawn
      • Research Site
    • New York, New York, United States, 10065
      • Recruiting
      • Research Site
    • Stony Brook, New York, United States, 11794-7263
      • Recruiting
      • Research Site
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • Research Site
    • Cincinnati, Ohio, United States, 45245
      • Recruiting
      • Research Site
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Research Site
  • Pennsylvania
    • York, Pennsylvania, United States, 17403
      • Withdrawn
      • Research Site
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • Research Site
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Recruiting
      • Research Site
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Research Site
  • Texas
    • Dallas, Texas, United States, 75246
      • Recruiting
      • Research Site
    • Dallas, Texas, United States, 75230
      • Withdrawn
      • Research Site
    • Dallas, Texas, United States, 75246
      • Withdrawn
      • Research Site
    • El Paso, Texas, United States, 79902
      • Recruiting
      • Research Site
    • Flower Mound, Texas, United States, 75028
      • Withdrawn
      • Research Site
    • Fort Worth, Texas, United States, 76104
      • Withdrawn
      • Research Site
    • Houston, Texas, United States, 77054
      • Withdrawn
      • Research Site
    • Houston, Texas, United States, 77090
      • Withdrawn
      • Research Site
    • Houston, Texas, United States, 77098
      • Withdrawn
      • Research Site
    • Kingwood, Texas, United States, 77339
      • Withdrawn
      • Research Site
    • McKinney, Texas, United States, 75071
      • Withdrawn
      • Research Site
    • Sugar Land, Texas, United States, 77479
      • Recruiting
      • Research Site
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Recruiting
      • Research Site
    • Fairfax, Virginia, United States, 22031
      • 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
    • Tacoma, Washington, United States, 98405
      • Recruiting
      • Research Site
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Withdrawn
      • Research Site
• Vietnam
  • Da Nang, Vietnam, 550000
    • Recruiting
    • Research Site
  • Hanoi, Vietnam, 100000
    • Recruiting
    • Research Site
  • Ho Chi Minh City, Vietnam, 700000
    • Recruiting
    • Research Site
  • Huế, Vietnam, 530000
    • Recruiting
    • Research Site
  • Hồ Chí Minh, Vietnam, 700000
    • Recruiting
    • Research Site
  • Viet Tri, Vietnam, 35000
    • Recruiting
    • Research Site
  • Vinh, Vietnam, 460000
    • Recruiting
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria

• Histologically or cytologically documented locally recurrent inoperable, which cannot be treated with curative intent, or metastatic TNBC, as defined by the ASCO-CAP guidelines.
• ECOG PS 0 or 1.
• Participants are expected to provide an FFPE tumour sample collected from a locally recurrent inoperable or metastatic tumour. Alternatively, an archival FFPE tumour sample can be submitted; it must have been collected ≤ 3 years prior to the participant signing informed consent (screening start).
• PD-L1 positive TNBC based on results from an appropriately validated investigational PD-L1 (22C3) assay (CPS ≥ 10) from a sponsor designated central laboratory.

• No prior chemotherapy or other systemic anti-cancer therapy for metastatic or locally recurrent inoperable breast cancer.

  - Patients with recurrent disease will be eligible if they have completed treatment for Stage I-III breast cancer, if indicated, and ≥6 months have elapsed between completion of treatment with curative intent and the first documented recurrence.

• Eligible for one of the chemotherapy options listed as ICC (paclitaxel, nab-paclitaxel, or gemcitabine + carboplatin).
• Measurable disease as per RECIST 1.1.
• Adequate bone marrow reserve and organ function.
• Male and female participants of childbearing potential must agree to use protocol-specified method(s) of contraception.

Key Exclusion Criteria

• As judged by investigator, any evidence of diseases (such as severe or uncontrolled medical conditions including systemic diseases, uncontrolled hypertension, serious gastrointestinal conditions associated with diarrhoea, chronic diverticulitis or previous complicated diverticulitis, history of allogeneic organ transplant, and active bleeding diseases, ongoing and active infection, significant cardiac conditions, substance abuse, psychiatric illness/social situation or psychological conditions) which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.
• History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 2 years before Cycle 1 Day 1 and of low potential risk for recurrence.

• Participants with a history of previously treated neoplastic spinal cord compression or treated, clinically inactive brain metastases that are no longer symptomatic, who require no treatment with corticosteroids or anticonvulsants, may be included in the study if they have recovered from acute toxic effects of radiotherapy.

  - Participants with treated clinically inactive brain metastases that are no longer symptomatic, who require no treatment with corticosteroids or anticonvulsants, may be included in the study if they have recovered from acute toxic effects of radiotherapy.

• Uncontrolled infection requiring IV antibiotics, antivirals or antifungals.
• Active or uncontrolled hepatitis B or C virus infection.
• Known HIV infection that is not well controlled.
• Uncontrolled or significant cardiac disease.
• History of non-infectious ILD/pneumonitis (including radiation pneumonitis) that required steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
• Clinically severe pulmonary function compromise.
• Clinically significant corneal disease.
• Active or prior documented autoimmune or inflammatory disorders.
• Prior exposure to any treatment including ADC containing a chemotherapeutic agent targeting topoisomerase I and TROP2-targeted therapy.
• Any concurrent anti-cancer treatment.
• Participants with a known severe hypersensitivity to PD-1/PD-L1 inhibitors or Dato-DXd.
• 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 + durvalumab; Arm 1: Dato-DXd + durvalumab	Drug: Dato-DXd; Provided in 100mg vials. IV infusion. Experimental drug.; Other Names: Datopotamab deruxtecan (Dato-DXd, DS-1062a); Drug: Durvalumab; Provided in 500mg vials. IV infusion. Experimental drug.; Other Names: MEDI4736
Active Comparator: Investigator's Choice of Chemotherapy (ICC) in combination with pembrolizumab; Arm 2: Investigator's Choice of Chemotherapy (ICC) in combination with pembrolizumab (paclitaxel, nab-paclitaxel, or gemcitabine + carboplatin)	Drug: Paclitaxel; IV infusion. Active comparator.; Drug: Nab-paclitaxel; IV infusion. Active comparator.; Drug: Gemcitabine; IV infusion. Active comparator.; Drug: Carboplatin; IV infusion. Active comparator.; Drug: Pembrolizumab; IV infusion. Active comparator.
Experimental: Dato-DXd; Arm 3: Dato-DXd	Drug: Dato-DXd; Provided in 100mg vials. IV infusion. Experimental drug.; Other Names: Datopotamab deruxtecan (Dato-DXd, DS-1062a)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS)	PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause. The comparison will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy, receives another anticancer therapy or clinically progresses prior to RECIST 1.1 progression. However, if the participant progresses or dies immediately after 2 or more consecutive missed visits, the participant will be censored at the time of the latest evaluable assessment prior to the 2 missed visits. The measure of interest is the HR of PFS.	From randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause (anticipated to be up to 33 months).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is defined as the time from randomisation until the date of death due to any cause.	From randomisation until the date of death due to any cause (anticipated to be up to 64 months).
Objective Response Rate (ORR)	ORR is defined as the proportion of participants who have a CR or PR, as determined by the BICR/investigator assessment, per RECIST 1.1.	From randomisation up until progression (anticipated to be up to 33 months).
Duration of Response (DoR)	DoR is defined as the time from the date of first documented response until date of documented progression per RECIST 1.1, as assessed by BICR/investigator assessment or death due to any cause.	From the date of first documented response until date of documented progression per RECIST 1.1, as assessed by BICR/investigator assessment or death due to any cause (anticipated to be up to 33 months).
Progression-Free Survival (PFS) by Investigator assessment	PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by investigator, or death due to any cause.	From randomisation until progression per RECIST 1.1 as assessed by the investigator, or death due to any cause (anticipated to be up to 33 months).
Clinical Benefit Rate (CBR) at 24 weeks	CBR at 24 weeks is defined as the percentage of participants who have a CR or PR or who have SD, per RECIST 1.1, as assessed by BICR/per investigator assessment and derived from the raw tumour data for at least 23 weeks after randomisation.	From randomisation up until progression, or the last evaluable assessment in the absence of progression (anticipated to be up to 33 months).
Time to deterioration (TTD) in breast and arm symptoms in participants treated with Dato-DXd + durvalumab compared with ICC + pembrolizumab	TTD in breast symptoms and arm symptoms as measured by the arm symptoms scale from EORTC IL116 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.	From the date of randomisation to the date of deterioration (from randomization to 18 weeks post-progression).
Time to deterioration (TTD) in pain in participants treated with Dato-DXd + durvalumab compared with ICC + pembrolizumab	TTD in pain as measured by the EORTC IL199.	Time from the date of randomisation to the date of deterioration (from randomization to 18 weeks post-progression).
Time to deterioration (TTD) in physical functioning in participants treated with Dato-DXd + durvalumab compared with ICC + pembrolizumab	TTD in physical function as measured by the PROMIS Short Form v2.0 - Physical Function 8c.	From the date of randomisation to the date of deterioration (from randomization to 18 weeks post-progression).
Time to deterioration (TTD) in GHS/QoL in participants treated with Dato-DXd + durvalumab compared with ICC + pembrolizumab	TTD in GHS/QoL as measured by the GHS/QoL scale from EORTC IL172.	From the date of randomisation to the date of deterioration (from randomization to 18 weeks post-progression).
Time to First Subsequent Therapy (TFST)	TFST is defined as the time from randomisation until the start date of the first subsequent anticancer therapy after discontinuation of randomised treatment, or death due to any cause.	From randomisation until the start date of the first subsequent anticancer therapy after discontinuation of randomised treatment, or death due to any cause (anticipated to be up to 64 months).
Time to Second Subsequent Therapy (TSST)	TSST is defined as the time from randomisation until the start date of the second subsequent anticancer therapy after discontinuation of first subsequent treatment, or death due to any cause.	From randomisation until the start date of the second subsequent anti cancer therapy after discontinuation of first subsequent treatment, or death due to any cause (anticipated to be up to 64 months).
Progression Free Survival 2 (PFS2)	PFS2 will be defined as the time from the randomisation to the earliest progression event (following the initial progression), subsequent to first subsequent therapy, or death. The date of second progression will be recorded by the investigator in the eCRF and defined according to local standard clinical practice based on radiological or clinical progression.	From the randomisation to the earliest of the progression event (following the initial progression), subsequent to first subsequent therapy, or death (anticipated to be up to 64 months).
Pharmacokinetics of Dato-DXd in combination with durvalumab	Concentration of Dato-DXd, total anti-TROP2 antibody, and DXd (payload) in plasma.	From first dose to end of treatment (anticipated to be up to 33 months).
Immunogenicity of Dato-DXd in combination with durvalumab	Presence of antidrug antibodies for Dato-DXd (confirmatory results: positive or negative, titres).	From first dose to end of treatment safety follow-up (anticipated to be up to 33 months).
Safety and tolerability of Dato-DXd + durvalumab as compared with ICC + pembrolizumab	Safety and tolerability will be evaluated in the safety population in terms of AEs.	From first dose to end of treatment safety follow-up (anticipated to be up to 33 months).

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Daiichi Sankyo

Publications and helpful links

General Publications

• Schmid P, Oliveira M, O'Shaughnessy J, Cristofanilli M, Graff SL, Im SA, Loi S, Saji S, Wang S, Cescon DW, Hovey T, Nawrot A, Tse K, Vukovic P, Curigliano G. TROPION-Breast05: a randomized phase III study of Dato-DXd with or without durvalumab versus chemotherapy plus pembrolizumab in patients with PD-L1-high locally recurrent inoperable or metastatic triple-negative breast cancer. Ther Adv Med Oncol. 2025 Apr 17;17:17588359251327992. doi: 10.1177/17588359251327992. eCollection 2025.

Helpful Links

• Breast Cancer Study Locator details (for US)

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2023
• Primary Completion (Estimated): July 28, 2027
• Study Completion (Estimated): September 30, 2030

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Gemcitabine; Breast Cancer; Pembrolizumab; Metastatic; Carboplatin; Paclitaxel; Antibody Drug Conjugate (ADC); Inoperable; Durvalumab; Triple-negative; Dato-DXd; DS1062a; TROP2; Nab-paclitaxel; Datopotamab deruxtecan; DS1062; Immune Checkpoint Inhibitor (ICI); PD-1/PD-L1 Therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Neoplastic Processes; Skin Diseases; Breast Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Breast Neoplasms; Neoplasm Metastasis; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Coordination Complexes; Taxoids; Cyclodecanes; Diterpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Gemcitabine; Carboplatin; Paclitaxel; pembrolizumab; durvalumab; 130-nm albumin-bound paclitaxel
• Other Study ID Numbers: D7630C00001

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 Vivli.org. 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 approved.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer 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 anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
• 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