RECRUITING Phase 3 ClinicalTrials.gov

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 (TROPION-Breast05)

Sponsor: AstraZeneca • ClinicalTrials.gov ID: NCT06103864

Registry updated: 2026-09-25

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Description

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.

Interventions

Dato-DXd (Drug)
Provided in 100mg vials. IV infusion. Experimental drug.
Durvalumab (Drug)
Provided in 500mg vials. IV infusion. Experimental drug.
Paclitaxel (Drug)
IV infusion. Active comparator.
Nab-paclitaxel (Drug)
IV infusion. Active comparator.
Gemcitabine (Drug)
IV infusion. Active comparator.
Carboplatin (Drug)
IV infusion. Active comparator.
Pembrolizumab (Drug)
IV infusion. Active comparator.

Eligibility criteria

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.

Conditions

Breast Cancer

Locations

Research Site — Daphne, Alabama, United States
Research Site — Springdale, Arkansas, United States
Research Site — Duarte, California, United States
Research Site — Fountain Valley, California, United States
Research Site — Glendale, California, United States
Research Site — Sacramento, California, United States
Research Site — Santa Rosa, California, United States
Research Site — Aurora, Colorado, United States
Research Site — Denver, Colorado, United States
Research Site — New Haven, Connecticut, United States
Research Site — Altamonte Springs, Florida, United States
Research Site — Jacksonville, Florida, United States
Research Site — Miami, Florida, United States
Research Site — Palm Bay, Florida, United States
Research Site — Plantation, Florida, United States
Research Site — Atlanta, Georgia, United States
Research Site — Honolulu, Hawaii, United States
Research Site — Chicago, Illinois, United States
Research Site — Decatur, Illinois, United States
Research Site — Elmhurst, Illinois, United States
Research Site — Naperville, Illinois, United States
Research Site — New Albany, Indiana, United States
Research Site — Des Moines, Iowa, United States
Research Site — Lexington, Kentucky, United States
Research Site — Louisville, Kentucky, United States
Research Site — Louisville, Kentucky, United States
Research Site — Baton Rouge, Louisiana, United States
Research Site — Baton Rouge, Louisiana, United States
Research Site — Baltimore, Maryland, United States
Research Site — Columbia, Maryland, United States
Research Site — Boston, Massachusetts, United States
Research Site — Worcester, Massachusetts, United States
Research Site — Detroit, Michigan, United States
Research Site — Grand Rapids, Michigan, United States
Research Site — Saint Paul, Minnesota, United States
Research Site — Hattiesburg, Mississippi, United States
Research Site — St Louis, Missouri, United States
Research Site — Albuquerque, New Mexico, United States
Research Site — Albany, New York, United States
Research Site — New York, New York, United States
Research Site — Stony Brook, New York, United States
Research Site — Cincinnati, Ohio, United States
Research Site — Cincinnati, Ohio, United States
Research Site — Cleveland, Ohio, United States
Research Site — York, Pennsylvania, United States
Research Site — Providence, Rhode Island, United States
Research Site — Chattanooga, Tennessee, United States
Research Site — Nashville, Tennessee, United States
Research Site — Dallas, Texas, United States
Research Site — Dallas, Texas, United States
Research Site — Dallas, Texas, United States
Research Site — El Paso, Texas, United States
Research Site — Flower Mound, Texas, United States
Research Site — Fort Worth, Texas, United States
Research Site — Houston, Texas, United States
Research Site — Houston, Texas, United States
Research Site — Houston, Texas, United States
Research Site — Kingwood, Texas, United States
Research Site — McKinney, Texas, United States
Research Site — Sugar Land, Texas, United States
Research Site — Charlottesville, Virginia, United States
Research Site — Fairfax, Virginia, United States
Research Site — Midlothian, Virginia, United States
Research Site — Norfolk, Virginia, United States
Research Site — Roanoke, Virginia, United States
Research Site — Tacoma, Washington, United States
Research Site — Madison, Wisconsin, United States
Research Site — CABA, Argentina
Research Site — CABA, Argentina
Research Site — CABA, Argentina
Research Site — CABA, Argentina
Research Site — Ciudad Autónoma Buenos Aires, Argentina
Research Site — Ciudad de Buenos Aires, Argentina
Research Site — Rosario, Argentina
Research Site — San Nicolás de los Arroyos, Argentina
Research Site — Camperdown, Australia
Research Site — Darlinghurst, Australia
Research Site — Heidelberg, Australia
Research Site — Melbourne, Australia
Research Site — Nedlands, Australia
Research Site — Waratah, Australia
Research Site — Barretos, Brazil
Research Site — Curitiba, Brazil
Research Site — Florianópolis, Brazil
Research Site — Goiânia, Brazil
Research Site — Itajaí, Brazil
Research Site — Porto Alegre, Brazil
Research Site — Recife, Brazil
Research Site — São Paulo, Brazil
Research Site — São Paulo, Brazil
Research Site — Teresina, Brazil
Research Site — Barrie, Ontario, Canada
Research Site — Hamilton, Ontario, Canada
Research Site — Toronto, Ontario, Canada
Research Site — Greenfield Park, Quebec, Canada
Research Site — Montreal, Quebec, Canada
Research Site — Montreal, Quebec, Canada
Research Site — Québec, Quebec, Canada
Research Site — Regina, Saskatchewan, Canada
Research Site — Saskatoon, Saskatchewan, Canada
Research Site — Anyang, China
Research Site — Beijing, China
Research Site — Beijing, China
Research Site — Bengbu, China
Research Site — Changchun, China
Research Site — Changsha, China
Research Site — Changsha, China
Research Site — Chengdu, China
Research Site — Chengdu, China
Research Site — Chongqing, China
Research Site — Fuzhou, China
Research Site — Guangzhou, China
Research Site — Guangzhou, China
Research Site — Guangzhou, China
Research Site — Hangzhou, China
Research Site — Hangzhou, China
Research Site — Hangzhou, China
Research Site — Harbin, China
Research Site — Hefei, China
Research Site — Jinan, China
Research Site — Meizhou, China
Research Site — Nanchang, China
Research Site — Nanjing, China
Research Site — Nanjing, China
Research Site — Nanning, China
Research Site — Shandong, China
Research Site — Shanghai, China
Research Site — Shanghai, China
Research Site — Shenyang, China
Research Site — Taiyuan, China
Research Site — Tianjin, China
Research Site — Wenzhou, China
Research Site — Wuhan, China
Research Site — Wuhan, China
Research Site — Xi'an, China
Research Site — Xiamen, China
Research Site — Xintai, China
Research Site — Xuzhou, China
Research Site — Zhanjiang, China
Research Site — Zhengzhou, China
Research Site — Zhengzhou, China
Research Site — Lille, France
Research Site — Lyon, France
Research Site — Montpellier, France
Research Site — Paris, France
Research Site — Saint-Herblain, France
Research Site — Toulouse, France
Research Site — Vandœuvre-lès-Nancy, France
Research Site — Villejuif, France
Research Site — Düsseldorf, Germany
Research Site — Essen, Germany
Research Site — Georgsmarienhütte, Germany
Research Site — Hamburg, Germany
Research Site — Hanover, Germany
Research Site — Heidelberg, Germany
Research Site — Heilbronn, Germany
Research Site — Leipzig, Germany
Research Site — Hong Kong, Hong Kong
Research Site — Calicut, India
Research Site — Chennai, India
Research Site — Jaipur, India
Research Site — Kochi, India
Research Site — Kolkata, India
Research Site — Kottayam, India
Research Site — Marg Jaipur, India
Research Site — Mohali, India
Research Site — Mysuru, India
Research Site — Nagpur, India
Research Site — Nashik, India
Research Site — New Delhi, India
Research Site — New Delhi, India
Research Site — Puducherry, India
Research Site — Surat, India
Research Site — Thiruvananthapuram, India
Research Site — Vadodara, India
Research Site — Visakhapatnam, India
Research Site — Bergamo, Italy
Research Site — Empoli, Italy
Research Site — Milan, Italy
Research Site — Milan, Italy
Research Site — Modena, Italy
Research Site — Naples, Italy
Research Site — Padova, Italy
Research Site — Reggio Emilia, Italy
Research Site — Roma, Italy
Research Site — Rozzano, Italy
Research Site — Akashi-shi, Japan
Research Site — Bunkyō City, Japan
Research Site — Bunkyō City, Japan
Research Site — Chiba, Japan
Research Site — Chūōku, Japan
Research Site — Fukuoka, Japan
Research Site — Fukushima, Japan
Research Site — Gifu, Japan
Research Site — Hidaka-shi, Japan
Research Site — Hiroshima, Japan
Research Site — Hiroshima, Japan
Research Site — Isehara-shi, Japan
Research Site — Kamogawa-shi, Japan
Research Site — Kashiwa, Japan
Research Site — Kitaadachi-gun, Japan
Research Site — Kōtoku, Japan
Research Site — Kumamoto, Japan
Research Site — Kurume-shi, Japan
Research Site — Matsuyama, Japan
Research Site — Nagoya, Japan
Research Site — Nagoya, Japan
Research Site — Niigata, Japan
Research Site — Nishinomiya-shi, Japan
Research Site — Okayama, Japan
Research Site — Osaka, Japan
Research Site — Osakasayama-shi, Japan
Research Site — Ota-shi, Japan
Research Site — Sapporo, Japan
Research Site — Sendai, Japan
Research Site — Shinagawa-ku, Japan
Research Site — Shinjuku-ku, Japan
Research Site — Shinjuku-ku, Japan
Research Site — Tsu, Japan
Research Site — Tsukuba, Japan
Research Site — Yokohama, Japan
Research Site — CD Mexico, Mexico
Research Site — Guadalajara, Mexico
Research Site — Guadalajara, Mexico
Research Site — Mexico City, Mexico
Research Site — Mexico City, Mexico
Research Site — México, Mexico
Research Site — Tuxtla Gutiérrez, Mexico
Research Site — Bacolod, Philippines
Research Site — Cebu City, Philippines
Research Site — City of Muntinlupa, Philippines
Research Site — Manila, Philippines
Research Site — Quezon City, Philippines
Research Site — San Juan City, Philippines
Research Site — Bialystok, Poland
Research Site — Bydgoszcz, Poland
Research Site — Gdansk, Poland
Research Site — Gdynia, Poland
Research Site — Konin, Poland
Research Site — Krakow, Poland
Research Site — Krakow, Poland
Research Site — Legnica, Poland
Research Site — Lodz, Poland
Research Site — Lublin, Poland
Research Site — Przemyśl, Poland
Research Site — Warsaw, Poland
Research Site — Wroclaw, Poland
Research Site — Singapore, Singapore
Research Site — Singapore, Singapore
Research Site — Singapore, Singapore
Research Site — Singapore, Singapore
Research Site — Cape Town, South Africa
Research Site — Johannesburg, South Africa
Research Site — Johannesburg, South Africa
Research Site — Johannesburg, South Africa
Research Site — Paarl, South Africa
Research Site — Pretoria, South Africa
Research Site — Pretoria, South Africa
Research Site — Busan, South Korea
Research Site — Daegu, South Korea
Research Site — Goyang-si, South Korea
Research Site — Seongnam-si, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Barcelona, Spain
Research Site — Barcelona, Spain
Research Site — Granada, Spain
Research Site — Hospitalet deLlobregat, Spain
Research Site — Madrid, Spain
Research Site — Madrid, Spain
Research Site — Pamplona, Spain
Research Site — Santander, Spain
Research Site — Hsinchu, Taiwan
Research Site — Kaohsiung City, Taiwan
Research Site — Taichung, Taiwan
Research Site — Tainan, Taiwan
Research Site — Taipei, Taiwan
Research Site — Taipei, Taiwan
Research Site — Taipei, Taiwan
Research Site — Taipei, Taiwan
Research Site — Taoyuan, Taiwan
Research Site — Bangkok, Thailand
Research Site — Bangkok, Thailand
Research Site — Bangkok, Thailand
Research Site — Bangkok, Thailand
Research Site — Chiang Mai, Thailand
Research Site — Dusit, Thailand
Research Site — Khon Kaen, Thailand
Research Site — Songkhla, Thailand
Research Site — Ankara, Turkey (Türkiye)
Research Site — Ankara, Turkey (Türkiye)
Research Site — Besevler Ankara, Turkey (Türkiye)
Research Site — Istanbul, Turkey (Türkiye)
Research Site — Izmir, Turkey (Türkiye)
Research Site — Küçükçekmece, Turkey (Türkiye)
Research Site — Samsun, Turkey (Türkiye)
Research Site — Cardiff, United Kingdom
Research Site — Chelsea, United Kingdom
Research Site — Leicester, United Kingdom
Research Site — Liverpool, United Kingdom
Research Site — London, United Kingdom
Research Site — London, United Kingdom
Research Site — Oxford, United Kingdom
Research Site — Surrey, United Kingdom
Research Site — Sutton, United Kingdom
Research Site — Taunton, United Kingdom
Research Site — Da Nang, Vietnam
Research Site — Hanoi, Vietnam
Research Site — Ho Chi Minh City, Vietnam
Research Site — Hồ Chí Minh, Vietnam
Research Site — Huế, Vietnam
Research Site — Viet Tri, Vietnam
Research Site — Vinh, Vietnam

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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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