NCT06112379Active, not recruitingPhase 3
A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab Injections Before and After Surgery for the Treatment of Adult Patients with Breast Cancer
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)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 12 Oct 2026
Brief summary (registry, in English)
To demonstrate superiority of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy relative to 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, by investigator assessment of EFS.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 501 (estimated)
- First submitted
- 17 Nov 2023
- Start date
- 15 Apr 2024
- Lead sponsor
- Astrazeneca AB
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT06112379
- EU CT number
- 2023-505928-59-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 501
- 79 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Lab values
- History of any prior invasive breast malignancy - History of another primary malignancy except for non-breast malignancy treated with curative intent with no known active disease within 5 years before randomisation - Evidence of distant disease. - Clinically significant corneal disease. - Has active or uncontrolled hepatitis B or C virus. - Known HIV infection that is not well controlled. - Uncontrolled infection requiring i.v. antibiotics, antivirals or antifungals - Known to have active tuberculosis infection - Mean resting corrected QTcF interval > 470 ms obtained from ECG - Uncontrolled or significant cardiac disease. - History of non-infectious ILD/pneumonitis - Has severe pulmonary function compromise - Any prior or concurrent surgery, radiotherapy or any systemic anticancer therapy for TNBC or hormone receptor-low/HER2-negative breast cancer - For females only: is pregnant (confirmed with positive serum pregnancy test) or breastfeeding, or planning to become pregnant. - Female participants should refrain from breastfeeding from enrolment throughout the study and for at least 7 months after last dose of study intervention, or as dictated by local PI for SoC if longer. - Concurrent use of systemic hormone replacement therapy or oral hormonal contraception
Who the study is looking for
- Participant must be ≥ 18 years, at the time of signing the ICF. - Histologically confirmed Stage II or III unilateral or bilateral primary invasive TNBC or hormone receptor-low/HER2-negative breast cancer - ECOG PS of 0 or 1 - Provision of acceptable tumour sample - Adequate bone marrow reserve and organ function - Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies; and in alignment with protocol requirements.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (79)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vorarlberger Krankenhaus-Betriebsgesellschaft mbH Coordinator of this site? Confirm its status | Feldkirch | Austria | Active, not recruiting |
| Medizinische Universitaet Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Active, not recruiting |
| Ordensklinikum Linz GmbH Coordinator of this site? Confirm its status | Linz | Austria | Active, not recruiting |
| SCRI CCCIT Ges.m.b.H. Coordinator of this site? Confirm its status | Salzburg | Austria | Active, not recruiting |
| Ziekenhuis Aan De Stroom Coordinator of this site? Confirm its status | Antwerp | Belgium | Active, not recruiting |
| Algemeen Ziekenhuis klina Coordinator of this site? Confirm its status | Brasschaat | Belgium | Active, not recruiting |
| Grand Hopital de Charleroi Coordinator of this site? Confirm its status | Charleroi | Belgium | Active, not recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Active, not recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Active, not recruiting |
| Hopital De Libramont Coordinator of this site? Confirm its status | Libramont-Chevigny | Belgium | Active, not recruiting |
| Mbal Za Zhensko Zdrave Nadezhda OOD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Active, not recruiting |
| University Specialized Hospital For Active Treatment In Oncology EAD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Active, not recruiting |
| Haematologie-Onkologie im Zentrum MVZ GmbH Coordinator of this site? Confirm its status | Augsburg | Germany | Active, not recruiting |
| HELIOS Klinikum Berlin Buch GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| Vivantes MVZ GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| Staedtisches Klinikum Dessau Coordinator of this site? Confirm its status | Dessau-Rosslau | Germany | Active, not recruiting |
| Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR Coordinator of this site? Confirm its status | Dresden | Germany | Active, not recruiting |
| Universitaetsklinikum Erlangen AöR Coordinator of this site? Confirm its status | Erlangen | Germany | Active, not recruiting |
| KEM I Evang. Kliniken Essen-Mitte gGmbH Coordinator of this site? Confirm its status | Essen | Germany | Active, not recruiting |
| Klinikum Esslingen GmbH Coordinator of this site? Confirm its status | Esslingen am Neckar | Germany | Active, not recruiting |
| Agaplesion Frankfurter Diakonie Kliniken gGmbH Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Active, not recruiting |
| Praxis Fuer Interdisziplinaere Onkologie And Haematologie GbR Coordinator of this site? Confirm its status | Freiburg Im Breisgau | Germany | Active, not recruiting |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Active, not recruiting |
| DIAKOVERE Krankenhaus gGmbH Coordinator of this site? Confirm its status | Hanover | Germany | Active, not recruiting |
| Universitaetsklinikum Heidelberg AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Active, not recruiting |
| Universitaetsklinikum Schleswig-Holstein Coordinator of this site? Confirm its status | Kiel | Germany | Active, not recruiting |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR Coordinator of this site? Confirm its status | Mainz | Germany | Active, not recruiting |
| Universitat Heidelberg Coordinator of this site? Confirm its status | Mannheim | Germany | Active, not recruiting |
| Universitaetsklinikum Muenster AöR Coordinator of this site? Confirm its status | Muenster | Germany | Active, not recruiting |
| Rotkreuzklinikum Muenchen gGmbH Coordinator of this site? Confirm its status | Munich | Germany | Active, not recruiting |
| Klinikum Mutterhaus der Borromaeerinnen gGmbH Coordinator of this site? Confirm its status | Trier | Germany | Active, not recruiting |
| Ulm University Coordinator of this site? Confirm its status | Ulm | Germany | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario Clínico San Cecilio Coordinator of this site? Confirm its status | Granada | Spain | Active, not recruiting |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Active, not recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Beata María Ana Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Active, not recruiting |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Active, not recruiting |
| Institut Sainte-Catherine Coordinator of this site? Confirm its status | Avignon | France | Active, not recruiting |
| Centre Hospitalier de la Cote Basque Coordinator of this site? Confirm its status | Bayonne | France | Active, not recruiting |
| Centre Francois Baclesse Coordinator of this site? Confirm its status | Caen Cedex 5 | France | Active, not recruiting |
| Centre Jean Perrin Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Active, not recruiting |
| Polyclinique De Limoges Coordinator of this site? Confirm its status | Limoges Cedex I | France | Active, not recruiting |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Active, not recruiting |
| Institut Regional Du Cancer De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Active, not recruiting |
| Centre Antoine Lacassagne Coordinator of this site? Confirm its status | Nice Cedex 2 | France | Active, not recruiting |
| Hopital Saint Louis Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Institut Godinot Coordinator of this site? Confirm its status | Reims | France | Active, not recruiting |
| Institut Universitaire du Cancer Toulouse - Oncopole Coordinator of this site? Confirm its status | Toulouse | France | Active, not recruiting |
| Institut de cancérologie de Lorraine Coordinator of this site? Confirm its status | Vandoeuvre Les Nancy_ Cedex | France | Active, not recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Active, not recruiting |
| Orszagos Onkologiai Intezet Coordinator of this site? Confirm its status | Budapest XII | Hungary | Active, not recruiting |
| Bacs-Kiskun Varmegyei Oktatokorhaz Coordinator of this site? Confirm its status | Kecskemét | Hungary | Active, not recruiting |
| Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz Coordinator of this site? Confirm its status | Miskolc | Hungary | Active, not recruiting |
| Tolna Varmegyei Balassa Janos Korhaz Coordinator of this site? Confirm its status | Szekszárd | Hungary | Active, not recruiting |
| Azienda USL Toscana Centro Coordinator of this site? Confirm its status | Empoli | Italy | Active, not recruiting |
| Azienda Unita' Sanitaria Locale Toscana Nord Ovest Coordinator of this site? Confirm its status | Lucca | Italy | Active, not recruiting |
| Ospedale Generale Provinciale Di Macerata Coordinator of this site? Confirm its status | Macerata | Italy | Active, not recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Azienda Ospedaliero - Universitaria di Modena Coordinator of this site? Confirm its status | Modena | Italy | Active, not recruiting |
| IRCCS Istituto Nazionale Tumori Fondazione Pascale Coordinator of this site? Confirm its status | Naples | Italy | Active, not recruiting |
| Istituto Oncologico Veneto Coordinator of this site? Confirm its status | Padova | Italy | Active, not recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Humanitas Research Hospital Coordinator of this site? Confirm its status | Rozzano | Italy | Active, not recruiting |
| Pia Fondazione Di Culto E Religione Card G Panico Coordinator of this site? Confirm its status | Tricase | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Active, not recruiting |
| Azienda Sanitaria Universitaria Friuli Centrale Coordinator of this site? Confirm its status | Udine | Italy | Active, not recruiting |
| Bialostockie Centrum Onkologii im Marii Sklodowskiej Curie w Bialymstoku Coordinator of this site? Confirm its status | Bialystok | Poland | Active, not recruiting |
| Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Active, not recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Coordinator of this site? Confirm its status | Cracow | Poland | Active, not recruiting |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Active, not recruiting |
| Szpitale Pomorskie Sp z o o Coordinator of this site? Confirm its status | Gdynia | Poland | Active, not recruiting |
| Instytut Centrum Zdrowia Matki Polki Coordinator of this site? Confirm its status | Lodz | Poland | Active, not recruiting |
| Specjalistyczny Szpital Onkologiczny NU-MED Sp. z o.o. Coordinator of this site? Confirm its status | Tomaszów Mazowiecki | Poland | Active, not recruiting |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii Coordinator of this site? Confirm its status | Wroclaw | Poland | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.