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
NCT ID: NCT06103864
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
625 participants
INTERVENTIONAL
2023-11-23
2030-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dato-DXd + durvalumab
Arm 1: Dato-DXd + durvalumab
Dato-DXd
Provided in 100mg vials. IV infusion. Experimental drug.
Durvalumab
Provided in 500mg vials. IV infusion. Experimental drug.
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)
Paclitaxel
IV infusion. Active comparator.
Nab-paclitaxel
IV infusion. Active comparator.
Gemcitabine
IV infusion. Active comparator.
Carboplatin
IV infusion. Active comparator.
Pembrolizumab
IV infusion. Active comparator.
Dato-DXd
Arm 3: Dato-DXd
Dato-DXd
Provided in 100mg vials. IV infusion. Experimental drug.
Interventions
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Dato-DXd
Provided in 100mg vials. IV infusion. Experimental drug.
Durvalumab
Provided in 500mg vials. IV infusion. Experimental drug.
Paclitaxel
IV infusion. Active comparator.
Nab-paclitaxel
IV infusion. Active comparator.
Gemcitabine
IV infusion. Active comparator.
Carboplatin
IV infusion. Active comparator.
Pembrolizumab
IV infusion. Active comparator.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Daphne, Alabama, United States
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Springdale, Arkansas, United States
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Duarte, California, United States
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Glendale, California, United States
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Sacramento, California, United States
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Santa Rosa, California, United States
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Aurora, Colorado, United States
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New Haven, Connecticut, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Palm Bay, Florida, United States
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Plantation, Florida, United States
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Atlanta, Georgia, United States
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Honolulu, Hawaii, United States
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Chicago, Illinois, United States
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Decatur, Illinois, United States
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Elmhurst, Illinois, United States
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Naperville, Illinois, United States
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New Albany, Indiana, United States
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Des Moines, Iowa, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Louisville, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Baton Rouge, Louisiana, United States
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Baltimore, Maryland, United States
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Columbia, Maryland, United States
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Boston, Massachusetts, United States
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Worcester, Massachusetts, United States
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Detroit, Michigan, United States
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Grand Rapids, Michigan, United States
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Saint Paul, Minnesota, United States
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Hattiesburg, Mississippi, United States
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St Louis, Missouri, United States
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Albuquerque, New Mexico, United States
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Albany, New York, United States
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New York, New York, United States
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Stony Brook, New York, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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York, Pennsylvania, United States
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Providence, Rhode Island, United States
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Chattanooga, Tennessee, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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El Paso, Texas, United States
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Flower Mound, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Kingwood, Texas, United States
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McKinney, Texas, United States
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Sugar Land, Texas, United States
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Charlottesville, Virginia, United States
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Fairfax, Virginia, United States
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Midlothian, Virginia, United States
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Norfolk, Virginia, United States
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Roanoke, Virginia, United States
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Tacoma, Washington, United States
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Madison, Wisconsin, United States
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CABA, , Argentina
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CABA, , Argentina
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CABA, , Argentina
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CABA, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Rosario, , Argentina
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San Nicolás de los Arroyos, , Argentina
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Camperdown, , Australia
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Darlinghurst, , Australia
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Heidelberg, , Australia
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Melbourne, , Australia
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Nedlands, , Australia
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Waratah, , Australia
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Barretos, , Brazil
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Curitiba, , Brazil
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Porto Alegre, , Brazil
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Recife, , Brazil
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Teresina, , Brazil
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Barrie, Ontario, Canada
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Hamilton, Ontario, Canada
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Greenfield Park, Quebec, Canada
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Montreal, Quebec, Canada
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Regina, Saskatchewan, Canada
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Saskatoon, Saskatchewan, Canada
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Anyang, , China
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Beijing, , China
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Changsha, , China
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Chongqing, , China
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Nanjing, , China
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Nanjing, , China
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Nanning, , China
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Shanghai, , China
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Shenyang, , China
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Tianjin, , China
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Wenzhou, , China
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Xi'an, , China
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Xiamen, , China
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Xintai, , China
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Xuzhou, , China
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Zhanjiang, , China
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Zhengzhou, , China
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Zhengzhou, , China
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Lille, , France
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Lyon, , France
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Montpellier, , France
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Paris, , France
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Saint-Herblain, , France
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Toulouse, , France
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Vandœuvre-lès-Nancy, , France
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Villejuif, , France
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Düsseldorf, , Germany
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Essen, , Germany
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Georgsmarienhütte, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Heidelberg, , Germany
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Heilbronn, , Germany
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Leipzig, , Germany
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Shatin, , Hong Kong
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Calicut, , India
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Chennai, , India
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Jaipur, , India
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Kochi, , India
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Kolkata, , India
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Mohali, , India
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Mysuru, , India
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Nagpur, , India
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New Delhi, , India
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Puducherry, , India
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Surat, , India
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Visakhapatnam, , India
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Bergamo, , Italy
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Milan, , Italy
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Fukuoka, , Japan
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Gifu, , Japan
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Isehara-shi, , Japan
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Kamogawa-shi, , Japan
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Kashiwa, , Japan
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Kitaadachi-gun, , Japan
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Kōtoku, , Japan
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Kumamoto, , Japan
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Kurume-shi, , Japan
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Matsuyama, , Japan
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Nagoya, , Japan
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Nagoya, , Japan
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Niigata, , Japan
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Nishinomiya-shi, , Japan
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Okayama, , Japan
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Osaka, , Japan
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Osakasayama-shi, , Japan
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Ota-shi, , Japan
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Sapporo, , Japan
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Sendai, , Japan
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Shinagawa-ku, , Japan
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Shinjuku-ku, , Japan
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Shinjuku-ku, , Japan
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Tsu, , Japan
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Tsukuba, , Japan
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Yokohama, , Japan
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CD Mexico, , Mexico
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Guadalajara, , Mexico
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Guadalajara, , Mexico
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Mexico City, , Mexico
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México, , Mexico
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México, , Mexico
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Tuxtla Gutiérrez, , Mexico
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Bacolod, , Philippines
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Cebu City, , Philippines
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City of Muntinlupa, , Philippines
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Manila, , Philippines
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Quezon City, , Philippines
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San Juan City, , Philippines
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Bialystok, , Poland
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Bydgoszcz, , Poland
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Gdansk, , Poland
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Gdynia, , Poland
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Konin, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Legnica, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Przemyśl, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Singapore, , Singapore
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Singapore, , Singapore
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Singapore, , Singapore
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Singapore, , Singapore
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Cape Town, , South Africa
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Johannesburg, , South Africa
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Johannesburg, , South Africa
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Johannesburg, , South Africa
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Paarl, , South Africa
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Pretoria, , South Africa
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Busan, , South Korea
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Daegu, , South Korea
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Goyang-si, , South Korea
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Seongnam-si, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Barcelona, , Spain
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Barcelona, , Spain
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Granada, , Spain
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Hospitalet deLlobregat, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Pamplona, , Spain
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Santander, , Spain
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Hsinchu, , Taiwan
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Tainan, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Chiang Mai, , Thailand
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Dusit, , Thailand
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Khon Kaen, , Thailand
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Songkhla, , Thailand
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Besevler Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Küçükçekmece, , Turkey (Türkiye)
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Samsun, , Turkey (Türkiye)
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Cardiff, , United Kingdom
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Chelsea, , United Kingdom
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Leicester, , United Kingdom
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Liverpool, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Oxford, , United Kingdom
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Surrey, , United Kingdom
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Sutton, , United Kingdom
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Taunton, , United Kingdom
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Da Nang, , Vietnam
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Hanoi, , Vietnam
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Ho Chi Minh City, , Vietnam
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Hồ Chí Minh, , Vietnam
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Huế, , Vietnam
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Việt Trì, , Vietnam
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Vinh, , Vietnam
Countries
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Central Contacts
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References
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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.
Related Links
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Breast Cancer Study Locator details (for US)
Other Identifiers
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D7630C00001
Identifier Type: -
Identifier Source: org_study_id
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