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Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT06103864

Public ClinicalTrials.gov record NCT06103864. 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.

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ClinicalTrials.gov public records Last synced May 8, 2026, 2:55 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 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)

Study identification

NCT ID
NCT06103864
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
AstraZeneca
Industry
Enrollment
625 participants

Conditions and interventions

Conditions

Interventions

  • Carboplatin Drug
  • Dato-DXd Drug
  • Durvalumab Drug
  • Gemcitabine Drug
  • Nab-paclitaxel Drug
  • Paclitaxel Drug
  • Pembrolizumab Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
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 22, 2023
Primary completion
Jul 27, 2027
Completion
Sep 29, 2030
Last update posted
Apr 29, 2026

2023 – 2030

United States locations

U.S. sites
63
U.S. states
29
U.S. cities
57
Facility City State ZIP Site status
Research Site Daphne Alabama 36526 Recruiting
Research Site Springdale Arkansas 72762 Recruiting
Research Site Duarte California 91010 Withdrawn
Research Site Glendale California 91204 Recruiting
Research Site Sacramento California 95817 Recruiting
Research Site Santa Rosa California 95403 Withdrawn
Research Site Aurora Colorado 80012 Recruiting
Research Site New Haven Connecticut 06510 Recruiting
Research Site Jacksonville Florida 32256 Withdrawn
Research Site Miami Florida 33176 Recruiting
Research Site Palm Bay Florida 32909 Withdrawn
Research Site Plantation Florida 33324 Recruiting
Research Site Atlanta Georgia 30318 Suspended
Research Site Honolulu Hawaii 96819 Withdrawn
Research Site Chicago Illinois 60637 Recruiting
Research Site Decatur Illinois 62526 Withdrawn
Research Site Elmhurst Illinois 60126 Withdrawn
Research Site Naperville Illinois 60540 Withdrawn
Research Site New Albany Indiana 47150 Withdrawn
Research Site Des Moines Iowa 50309 Recruiting
Research Site Lexington Kentucky 40503 Withdrawn
Research Site Louisville Kentucky 40202 Withdrawn
Research Site Louisville Kentucky 40207 Withdrawn
Research Site Baton Rouge Louisiana 70808 Withdrawn
Research Site Baton Rouge Louisiana 70809 Recruiting
Research Site Baltimore Maryland 21215 Withdrawn
Research Site Columbia Maryland 21044 Recruiting
Research Site Boston Massachusetts 02111 Withdrawn
Research Site Worcester Massachusetts 01655 Withdrawn
Research Site Detroit Michigan 48201 Recruiting
Research Site Grand Rapids Michigan 49503 Withdrawn
Research Site Saint Paul Minnesota 55109 Recruiting
Research Site Hattiesburg Mississippi 39401 Withdrawn
Research Site St Louis Missouri 63129 Recruiting
Research Site Albuquerque New Mexico 87109 Recruiting
Research Site Albany New York 12206 Withdrawn
Research Site New York New York 10065 Recruiting
Research Site Stony Brook New York 11794-7263 Recruiting
Research Site Cincinnati Ohio 45219 Recruiting
Research Site Cincinnati Ohio 45245 Recruiting
Research Site Cleveland Ohio 44195 Recruiting
Research Site York Pennsylvania 17403 Withdrawn
Research Site Providence Rhode Island 02903 Recruiting
Research Site Chattanooga Tennessee 37404 Recruiting
Research Site Nashville Tennessee 37203 Recruiting
Research Site Dallas Texas 75230 Withdrawn
Research Site Dallas Texas 75246 Withdrawn
Research Site El Paso Texas 79902 Recruiting
Research Site Flower Mound Texas 75028 Withdrawn
Research Site Fort Worth Texas 76104 Withdrawn
Research Site Houston Texas 77054 Withdrawn
Research Site Houston Texas 77090 Withdrawn
Research Site Houston Texas 77098 Withdrawn
Research Site Kingwood Texas 77339 Withdrawn
Research Site McKinney Texas 75071 Withdrawn
Research Site Sugar Land Texas 77479 Recruiting
Research Site Charlottesville Virginia 22903 Recruiting
Research Site Fairfax Virginia 22031 Recruiting
Research Site Midlothian Virginia 23114 Recruiting
Research Site Norfolk Virginia 23502 Recruiting
Research Site Roanoke Virginia 24014 Recruiting
Research Site Tacoma Washington 98405 Recruiting
Research Site Madison Wisconsin 53792 Withdrawn

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 250 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06103864, 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 Apr 29, 2026 · Synced May 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06103864 live on ClinicalTrials.gov.

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