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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
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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (79)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Vorarlberger Krankenhaus-Betriebsgesellschaft mbH
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FeldkirchAustriaActive, not recruiting
Medizinische Universitaet Innsbruck
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InnsbruckAustriaActive, not recruiting
Ordensklinikum Linz GmbH
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LinzAustriaActive, not recruiting
SCRI CCCIT Ges.m.b.H.
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SalzburgAustriaActive, not recruiting
Ziekenhuis Aan De Stroom
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AntwerpBelgiumActive, not recruiting
Algemeen Ziekenhuis klina
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BrasschaatBelgiumActive, not recruiting
Grand Hopital de Charleroi
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CharleroiBelgiumActive, not recruiting
Universitair Ziekenhuis Gent
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GentBelgiumActive, not recruiting
UZ Leuven
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LeuvenBelgiumActive, not recruiting
Hopital De Libramont
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Libramont-ChevignyBelgiumActive, not recruiting
Mbal Za Zhensko Zdrave Nadezhda OOD
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SofiaBulgariaActive, not recruiting
University Specialized Hospital For Active Treatment In Oncology EAD
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SofiyaBulgariaActive, not recruiting
Haematologie-Onkologie im Zentrum MVZ GmbH
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AugsburgGermanyActive, not recruiting
HELIOS Klinikum Berlin Buch GmbH
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BerlinGermanyActive, not recruiting
Vivantes MVZ GmbH
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BerlinGermanyActive, not recruiting
Staedtisches Klinikum Dessau
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Dessau-RosslauGermanyActive, not recruiting
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
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DresdenGermanyActive, not recruiting
Universitaetsklinikum Erlangen AöR
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ErlangenGermanyActive, not recruiting
KEM I Evang. Kliniken Essen-Mitte gGmbH
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EssenGermanyActive, not recruiting
Klinikum Esslingen GmbH
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Esslingen am NeckarGermanyActive, not recruiting
Agaplesion Frankfurter Diakonie Kliniken gGmbH
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Frankfurt am MainGermanyActive, not recruiting
Praxis Fuer Interdisziplinaere Onkologie And Haematologie GbR
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Freiburg Im BreisgauGermanyActive, not recruiting
University Medical Center Hamburg-Eppendorf
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HamburgGermanyActive, not recruiting
DIAKOVERE Krankenhaus gGmbH
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HanoverGermanyActive, not recruiting
Universitaetsklinikum Heidelberg AöR
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HeidelbergGermanyActive, not recruiting
Universitaetsklinikum Schleswig-Holstein
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KielGermanyActive, not recruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
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MainzGermanyActive, not recruiting
Universitat Heidelberg
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MannheimGermanyActive, not recruiting
Universitaetsklinikum Muenster AöR
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MuensterGermanyActive, not recruiting
Rotkreuzklinikum Muenchen gGmbH
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MunichGermanyActive, not recruiting
Klinikum Mutterhaus der Borromaeerinnen gGmbH
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TrierGermanyActive, not recruiting
Ulm University
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UlmGermanyActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital Clinic de Barcelona
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BarcelonaSpainActive, not recruiting
Hospital Universitario Clínico San Cecilio
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GranadaSpainActive, not recruiting
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainActive, not recruiting
Hospital Universitario Ramón y Cajal
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MadridSpainActive, not recruiting
Hospital Beata María Ana
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MadridSpainActive, not recruiting
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainActive, not recruiting
Hospital Universitario Virgen De La Macarena
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SevillaSpainActive, not recruiting
Hospital Clinico Universitario Lozano Blesa
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ZaragozaSpainActive, not recruiting
Institut Sainte-Catherine
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AvignonFranceActive, not recruiting
Centre Hospitalier de la Cote Basque
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BayonneFranceActive, not recruiting
Centre Francois Baclesse
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Caen Cedex 5FranceActive, not recruiting
Centre Jean Perrin
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Clermont-FerrandFranceActive, not recruiting
Polyclinique De Limoges
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Limoges Cedex IFranceActive, not recruiting
Institut Paoli-Calmettes
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MarseilleFranceActive, not recruiting
Institut Regional Du Cancer De Montpellier
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Montpellier Cedex 5FranceActive, not recruiting
Centre Antoine Lacassagne
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Nice Cedex 2FranceActive, not recruiting
Hopital Saint Louis
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ParisFranceActive, not recruiting
Institut Godinot
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ReimsFranceActive, not recruiting
Institut Universitaire du Cancer Toulouse - Oncopole
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ToulouseFranceActive, not recruiting
Institut de cancérologie de Lorraine
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Vandoeuvre Les Nancy_ CedexFranceActive, not recruiting
Institut Gustave Roussy
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VillejuifFranceActive, not recruiting
Orszagos Onkologiai Intezet
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Budapest XIIHungaryActive, not recruiting
Bacs-Kiskun Varmegyei Oktatokorhaz
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KecskemétHungaryActive, not recruiting
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz
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MiskolcHungaryActive, not recruiting
Tolna Varmegyei Balassa Janos Korhaz
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SzekszárdHungaryActive, not recruiting
Azienda USL Toscana Centro
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EmpoliItalyActive, not recruiting
Azienda Unita' Sanitaria Locale Toscana Nord Ovest
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LuccaItalyActive, not recruiting
Ospedale Generale Provinciale Di Macerata
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MacerataItalyActive, not recruiting
Ospedale San Raffaele S.r.l.
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MilanItalyActive, not recruiting
Azienda Ospedaliero - Universitaria di Modena
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ModenaItalyActive, not recruiting
IRCCS Istituto Nazionale Tumori Fondazione Pascale
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NaplesItalyActive, not recruiting
Istituto Oncologico Veneto
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PadovaItalyActive, not recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyActive, not recruiting
Humanitas Research Hospital
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RozzanoItalyActive, not recruiting
Pia Fondazione Di Culto E Religione Card G Panico
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TricaseItalyActive, not recruiting
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyActive, not recruiting
Azienda Sanitaria Universitaria Friuli Centrale
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UdineItalyActive, not recruiting
Bialostockie Centrum Onkologii im Marii Sklodowskiej Curie w Bialymstoku
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BialystokPolandActive, not recruiting
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
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BydgoszczPolandActive, not recruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
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CracowPolandActive, not recruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandActive, not recruiting
Szpitale Pomorskie Sp z o o
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GdyniaPolandActive, not recruiting
Instytut Centrum Zdrowia Matki Polki
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LodzPolandActive, not recruiting
Specjalistyczny Szpital Onkologiczny NU-MED Sp. z o.o.
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Tomaszów MazowieckiPolandActive, not recruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandActive, not recruiting
Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii
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WroclawPolandActive, not recruiting

This page is information, not medical advice. Discuss any trial with your doctor.