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
Public ClinicalTrials.gov record NCT06112379. 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.
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 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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06112379
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,902 participants
Conditions and interventions
Conditions
Interventions
- Dato-DXd Drug
- Durvalumab Drug
- Pembrolizumab Drug
- Doxorubicin Drug
- Epirubicin Drug
- Cyclophosphamide Drug
- Paclitaxel Drug
- Carboplatin Drug
- Capecitabine Drug
- Olaparib 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 14, 2023 (Actual)
- Primary completion
- Nov 20, 2028 (Estimated)
- Completion
- Sep 23, 2032 (Estimated)
- Last update posted
- Jul 13, 2026
2023 – 2032
United States locations
- U.S. sites
- 58
- U.S. states
- 28
- U.S. cities
- 56
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Daphne | Alabama | 36526 | — |
| Research Site | Prescott | Arizona | 86301 | — |
| Research Site | Jonesboro | Arkansas | 72401 | — |
| Research Site | Rogers | Arkansas | 72758 | — |
| Research Site | Los Angeles | California | 90033 | — |
| Research Site | Santa Barbara | California | 93105 | — |
| Research Site | Santa Rosa | California | 92805 | — |
| Research Site | Torrance | California | 90505 | — |
| Research Site | Aurora | Colorado | 80045 | — |
| Research Site | Longmont | Colorado | 80504 | — |
| Research Site | Bridgeport | Connecticut | 06606 | — |
| Research Site | New Haven | Connecticut | 06510 | — |
| Research Site | Fort Myers | Florida | 33901 | — |
| Research Site | Jacksonville | Florida | 32256 | — |
| Research Site | St. Petersburg | Florida | 33705 | — |
| Research Site | West Palm Beach | Florida | 33401 | — |
| Research Site | Atlanta | Georgia | 30342 | — |
| Research Site | Des Moines | Iowa | 50309 | — |
| Research Site | Edgewood | Kentucky | 41017 | — |
| Research Site | Louisville | Kentucky | 40202 | — |
| Research Site | Baton Rouge | Louisiana | 70817 | — |
| Research Site | Annapolis | Maryland | 21401 | — |
| Research Site | Boston | Massachusetts | 02215 | — |
| Research Site | Grand Rapids | Michigan | 49503 | — |
| Research Site | Traverse City | Michigan | 49684 | — |
| Research Site | Burnsville | Minnesota | 55337 | — |
| Research Site | Minneapolis | Minnesota | 55407 | — |
| Research Site | Columbia | Missouri | 65212 | — |
| Research Site | Omaha | Nebraska | 68130 | — |
| Research Site | East Brunswick | New Jersey | 08816 | — |
| Research Site | New Brunswick | New Jersey | 08901 | — |
| Research Site | Santa Fe | New Mexico | 87505 | — |
| Research Site | New York | New York | 10065 | — |
| Research Site | Charlotte | North Carolina | 28204 | — |
| Research Site | Durham | North Carolina | 27710 | — |
| Research Site | Winston-Salem | North Carolina | 27103 | — |
| Research Site | Blue Ash | Ohio | 45242 | — |
| Research Site | Eugene | Oregon | 97401 | — |
| Research Site | Portland | Oregon | 97223 | — |
| Research Site | Philadelphia | Pennsylvania | 19104 | — |
| Research Site | Pittsburgh | Pennsylvania | 15212 | — |
| Research Site | Chattanooga | Tennessee | 37404 | — |
| Research Site | Nashville | Tennessee | 37203 | — |
| Research Site | Austin | Texas | 78731 | — |
| Research Site | Dallas | Texas | 75231 | — |
| Research Site | Dallas | Texas | 75235 | — |
| Research Site | Dallas | Texas | 75390-8843 | — |
| Research Site | El Paso | Texas | 79902 | — |
| Research Site | Flower Mound | Texas | 75028 | — |
| Research Site | Fort Worth | Texas | 76104 | — |
| Research Site | Houston | Texas | 77030 | — |
| Research Site | San Antonio | Texas | 78240 | — |
| Research Site | Webster | Texas | 77598 | — |
| Research Site | Fairfax | Virginia | 22031 | — |
| Research Site | Norfolk | Virginia | 23502 | — |
| Research Site | Roanoke | Virginia | 24014 | — |
| Research Site | Winchester | Virginia | 22601 | — |
| Research Site | Tacoma | Washington | 98405 | — |
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 225 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06112379, 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 Jul 13, 2026 · Synced Oct 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06112379 live on ClinicalTrials.gov.