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Evaluating Dato-DXd and Durvalumab for Treating Certain Types of 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)

Phase 3 Interventional AstraZeneca · NCT06112379

This study is testing a new combination treatment for certain types of breast cancer to see if it works better than the standard therapy.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1728 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsdurvalumab, pembrolizumab, chemotherapy
Locations355 sites (Daphne, Alabama and 354 other locations)
Trial IDNCT06112379 on ClinicalTrials.gov

What this trial studies

This Phase III clinical trial is a multicenter, global study that compares the effectiveness and safety of neoadjuvant Dato-DXd combined with durvalumab against neoadjuvant pembrolizumab plus chemotherapy in patients with untreated triple-negative breast cancer (TNBC) or hormone receptor-low/HER2-negative breast cancer. Participants will receive either treatment followed by adjuvant therapy to assess the primary outcomes of pathologic complete response (pCR) and event-free survival (EFS). The study aims to determine if the new combination therapy offers superior results compared to the standard treatment.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed Stage II or III TNBC or hormone receptor-low/HER2-negative breast cancer.

Not a fit: Patients with a history of prior invasive breast malignancy or those with distant disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with aggressive forms of breast cancer.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches in breast cancer, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 tumor 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 aligned with protocol requirements.

Exclusion criteria:

* History of any prior invasive breast malignancy
* History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 5 years before randomization.
* active or prior documented autoimmune or inflammatory disorders.
* Evidence of distant disease.
* Clinically significant corneal disease.
* Has active or uncontrolled hepatitis B or C virus infection.
* Known HIV infection that is not well controlled.
* Uncontrolled infection requiring i.v. antibiotics, antivirals or antifungals; suspected infections; or inability to rule out infections.
* 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 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

Where this trial is running

Daphne, Alabama and 354 other locations

+305 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Breast CancerDato-DXdDS1062aTROP2TNBCHR low:Datopotamab deruxtecanAntibody Drug Conjugate
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.