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A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer
Sponsor: AstraZeneca
Summary
This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer.
Official title: A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients With Previously Untreated Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer (D926QC00001; TROPION-Breast04)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1902
Start Date
2023-11-14
Completion Date
2032-09-23
Last Updated
2026-10-21
Healthy Volunteers
No
Conditions
Interventions
Dato-DXd
Experimental drug IV infusion
Durvalumab
Experimental drug IV Infusion
Pembrolizumab
IV Infusion Active comparator
Doxorubicin
IV infusion Experimental/Active Comparator
Epirubicin
IV Infusion Experimental/Active Comparator
Cyclophosphamide
IV infusion Experimental/Active Comparator
Paclitaxel
IV infusion Experimental/Active Comparator
Carboplatin
IV infusion Experimental/Active Comparator
Capecitabine
Tablet Oral route of administration Experimental/Active Comparator
Olaparib
Tablet Oral route of administration Experimental/Active Comparator
Locations (283)
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Daphne, Alabama, United States
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Prescott, Arizona, United States
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Jonesboro, Arkansas, United States
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Rogers, Arkansas, United States
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Los Angeles, California, United States
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Santa Barbara, California, United States
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Santa Rosa, California, United States
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Torrance, California, United States
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Aurora, Colorado, United States
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Longmont, Colorado, United States
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Bridgeport, Connecticut, United States
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New Haven, Connecticut, United States
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Fort Myers, Florida, United States
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Jacksonville, Florida, United States
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St. Petersburg, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Des Moines, Iowa, United States
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Edgewood, Kentucky, United States
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Louisville, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Annapolis, Maryland, United States
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Boston, Massachusetts, United States
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Grand Rapids, Michigan, United States
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Traverse City, Michigan, United States
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Burnsville, Minnesota, United States
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Minneapolis, Minnesota, United States
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Columbia, Missouri, United States
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Omaha, Nebraska, United States
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East Brunswick, New Jersey, United States
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New Brunswick, New Jersey, United States
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Santa Fe, New Mexico, United States
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New York, New York, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Blue Ash, Ohio, United States
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Eugene, Oregon, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Chattanooga, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, 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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San Antonio, Texas, United States
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Webster, Texas, United States
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Fairfax, Virginia, United States
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Norfolk, Virginia, United States
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Roanoke, Virginia, United States
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Winchester, Virginia, United States
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Tacoma, Washington, United States
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East Melbourne, Australia
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Feldkirch, Austria
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Innsbruck, Austria
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Linz, Austria
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Salzburg, Austria
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Antwerp, Belgium
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Brasschaat, Belgium
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Charleroi, Belgium
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Ghent, Belgium
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Leuven, Belgium
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Libramont-Chevigny, Belgium
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Brasília, Brazil
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Curitiba, Brazil
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Fortaleza, Brazil
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Londrina, Brazil
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Natal, Brazil
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Porto Alegre, Brazil
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Porto Alegre, Brazil
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Ribeirão Preto, Brazil
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Santo André, Brazil
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São Paulo, Brazil
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Taubaté, Brazil
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Vitória, Brazil
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Shumen, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Calgary, Alberta, Canada
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Vancouver, British Columbia, Canada
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Barrie, Ontario, Canada
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London, Ontario, Canada
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Oshawa, Ontario, Canada
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Toronto, Ontario, Canada
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Lévis, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Saint-Jérôme, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Montreal, Canada
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Ottawa, Canada
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Beijing, China
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Bengbu, China