ClinicalTrials.gov record
Active, not recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT05629585

Public ClinicalTrials.gov record NCT05629585. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 4, 2026, 8:26 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Study identification

NCT ID
NCT05629585
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
AstraZeneca
Industry
Enrollment
1,174 participants

Conditions and interventions

Conditions

Interventions

  • Capecitabine Drug
  • Dato-DXd Drug
  • Durvalumab Drug
  • Pembrolizumab Drug

Drug

Eligibility (public fields only)

Age range
18 Years to 130 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 27, 2022
Primary completion
Sep 19, 2027
Completion
Jan 29, 2030
Last update posted
Mar 17, 2026

2022 – 2030

United States locations

U.S. sites
88
U.S. states
30
U.S. cities
73
Facility City State ZIP Site status
Research Site Gilbert Arizona 85234
Research Site Tucson Arizona 85711
Research Site Tucson Arizona 85719
Research Site Hot Springs Arkansas 71913
Research Site Little Rock Arkansas 72205
Research Site Springdale Arkansas 72762
Research Site Beverly Hills California 90211
Research Site Costa Mesa California 92627
Research Site Duarte California 91010
Research Site Fountain Valley California 92708
Research Site Irvine California 92618
Research Site La Jolla California 92093
Research Site Lakewood California 90805
Research Site Los Angeles California 90017
Research Site Los Angeles California 90095
Research Site Newport Beach California 92660
Research Site Newport Beach California 92663
Research Site Orange California 92868
Research Site Roseville California 95661
Research Site Upland California 91786
Research Site Vallejo California 94589
Research Site Denver Colorado 80220
Research Site New Haven Connecticut 06510
Research Site Newark Delaware 19713
Research Site Washington D.C. District of Columbia 20007
Research Site Altamonte Springs Florida 32701
Research Site Hollywood Florida 33021
Research Site Miami Beach Florida 33140
Research Site Tallahassee Florida 32308
Research Site West Palm Beach Florida 33401
Research Site Athens Georgia 30607
Research Site Atlanta Georgia 30318
Research Site Atlanta Georgia 30322
Research Site Chicago Illinois 60611
Research Site Maywood Illinois 60153
Research Site Westwood Kansas 66205
Research Site Lexington Kentucky 40503
Research Site Louisville Kentucky 40202
Research Site Louisville Kentucky 40207
Research Site Louisville Kentucky 40241
Research Site New Orleans Louisiana 70121
Research Site Annapolis Maryland 21401
Research Site Baltimore Maryland 21202
Research Site Columbia Maryland 21044
Research Site Boston Massachusetts 02114
Research Site Detroit Michigan 48201
Research Site St Louis Missouri 63110
Research Site Camden New Jersey 08103
Research Site Albuquerque New Mexico 87109
Research Site New York New York 10011
Research Site New York New York 10021
Research Site New York New York 10029
Research Site New York New York 10032
Research Site New York New York 10065
Research Site Charlotte North Carolina 28204
Research Site Canton Ohio 44710
Research Site Cleveland Ohio 44106
Research Site Cleveland Ohio 44111
Research Site Cleveland Ohio 44195
Research Site Columbus Ohio 43219
Research Site Portland Oregon 97227
Research Site Hershey Pennsylvania 17033
Research Site Philadelphia Pennsylvania 19111
Research Site Pittsburgh Pennsylvania 15213
Research Site Providence Rhode Island 02903
Research Site Germantown Tennessee 38138
Research Site Memphis Tennessee 38120
Research Site Nashville Tennessee 37203
Research Site Nashville Tennessee 37232
Research Site Bedford Texas 76022
Research Site Dallas Texas 75246
Research Site Denton Texas 76201
Research Site Fort Worth Texas 76104
Research Site Houston Texas 77024
Research Site Houston Texas 77030
Research Site McAllen Texas 78503
Research Site Tyler Texas 75702
Research Site Fairfax Virginia 22031
Research Site Gainesville Virginia 20155
Research Site Midlothian Virginia 23114
Research Site Norfolk Virginia 23502
Research Site Edmonds Washington 98026
Research Site Issaquah Washington 98029
Research Site Puyallup Washington 98373
Research Site Seattle Washington 98104
Research Site Seattle Washington 98133
Research Site Spokane Valley Washington 99216
Research Site Morgantown West Virginia 26506

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 188 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05629585, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 17, 2026 · Synced May 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05629585 live on ClinicalTrials.gov.

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