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Looking for participantsPhase3

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 (TROPION-Breast05)

Sponsor: AstraZeneca

NCT ID: NCT06103864

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Dato-DXd (drug), Durvalumab (drug), Paclitaxel (drug), Nab-paclitaxel (drug)
How long the study runs
Study runs about 82 months (dates as stated)
About the drug or intervention
Dato-DXd — drug: Provided in 100mg vials. · Durvalumab — drug: Provided in 500mg vials. · Paclitaxel — drug: IV infusion. · Nab-paclitaxel — drug: IV infusion. · Gemcitabine — drug: IV infusion. · Carboplatin — drug: IV infusion. · Pembrolizumab — drug: IV infusion.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
625
Started
2023-11-23
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for breast cancer
  • • Phase3 - 625 participants
  • • This is a Phase III, randomised, open-label, 3-arm, multicentre, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with investigator's choice chemotherapy in combination with pembrolizumab in participants with PD-L1 positive locally recurrent inoperable or metastatic TNBC

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with breast cancer

Where?

  • • Cardiff - Research Site
  • • Chelsea - Research Site
  • • Leicester - Research Site
  • • Liverpool - Research Site
  • • +6 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

This is a Phase III, randomised, open-label, 3-arm, multicentre, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with investigator's choice chemotherapy in combination with pembrolizumab in participants with PD-L1 positive locally recurrent inoperable or metastatic TNBC.

More detail

The primary objective of the study is to demonstrate superiority of Dato-DXd + durvalumab relative to ICC + pembrolizumab by assessment of PFS as assessed by BICR in participants with PD-L1 positive locally recurrent inoperable or metastatic TNBC. The study will be stratified based on geographic location (US/Canada/Europe vs. Dato-DXd monotherapy enrolling countries vs. rest of world), disease-free interval (DFI) history (de novo vs. prior DFI 6 to 12 months vs. prior DFI \> 12 months), and prior PD-1/PD-L1 treatment for early stage TNBC (yes vs. no). This study aims to see if Dato-DXd with durvalumab allows patients to live longer without their breast cancer getting worse, or simply to live longer, compared to patients receiving standard of care chemotherapy and pembrolizumab. This study is also looking to see how the treatment and the breast cancer affects patients' quality of life.

Breast Cancer

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

PD-L1L1 positivewith positive

Treatment history

Treatments you must have had:

  • ✓ been collected ≤ 3 years

What the study is looking for

  • ✓Key Inclusion Criteria
  • ✓Histologically or cytologically documented locally recurrent inoperable, which cannot be treated with curative...
  • ✓ECOG PS 0 or 1.
  • ✓PD-L1 positive TNBC based on results from an appropriately validated investigational PD-L1 (22C3) assay (CPS ≥ 10)...
  • ✓No prior drug treatment or other systemic anti-cancer therapy for that has spread or locally recurrent inoperable breast...
See the full criteria
Key Inclusion Criteria * Histologically or cytologically documented locally recurrent inoperable, which cannot be treated with curative intent, or metastatic TNBC, as defined by the ASCO-CAP guidelines. * ECOG PS 0 or 1. * Participants are expected to provide an FFPE tumour sample collected from a locally recurrent inoperable or metastatic tumour. Alternatively, an archival FFPE tumour sample can be submitted; it must have been collected ≤ 3 years prior to the participant signing informed consent (screening start). * PD-L1 positive TNBC based on results from an appropriately validated investigational PD-L1 (22C3) assay (CPS ≥ 10) from a sponsor designated central laboratory. * No prior chemotherapy or other systemic anti-cancer therapy for metastatic or locally recurrent inoperable breast cancer. \- Patients with recurrent disease will be eligible if they have completed treatment for Stage I-III breast cancer, if indicated, and ≥6 months have elapsed between completion of treatment with curative intent and the first documented recurrence. * Eligible for one of the chemotherapy options listed as ICC (paclitaxel, nab-paclitaxel, or gemcitabine + carboplatin). * Measurable disease as per RECIST 1.1. * Adequate bone marrow reserve and organ function. * Male and female participants of childbearing potential must agree to use protocol-specified method(s) of contraception. Key Exclusion Criteria * As judged by investigator, any evidence of diseases (such as severe or uncontrolled medical conditions including systemic diseases, uncontrolled hypertension, serious gastrointestinal conditions associated with diarrhoea, chronic diverticulitis or previous complicated diverticulitis, history of allogeneic organ transplant, and active bleeding diseases, ongoing and active infection, significant cardiac conditions, substance abuse, psychiatric illness/social situation or psychological conditions) which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol. * History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 2 years before Cycle 1 Day 1 and of low potential risk for recurrence. * Participants with a history of previously treated neoplastic spinal cord compression or treated, clinically inactive brain metastases that are no longer symptomatic, who require no treatment with corticosteroids or anticonvulsants, may be included in the study if they have recovered from acute toxic effects of radiotherapy. \- Participants with treated clinically inactive brain metastases that are no longer symptomatic, who require no treatment with corticosteroids or anticonvulsants, may be included in the study if they have recovered from acute toxic effects of radiotherapy. * Uncontrolled infection requiring IV antibiotics, antivirals or antifungals. * Active or uncontrolled hepatitis B or C virus infection. * Known HIV infection that is not well controlled. * Uncontrolled or significant cardiac disease. * History of non-infectious ILD/pneumonitis (including radiation pneumonitis) that required steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening. * Clinically severe pulmonary function compromise. * Clinically significant corneal disease. * Active or prior documented autoimmune or inflammatory disorders. * Prior exposure to any treatment including ADC containing a chemotherapeutic agent targeting topoisomerase I and TROP2-targeted therapy. * Any concurrent anti-cancer treatment. * Participants with a known severe hypersensitivity to PD-1/PD-L1 inhibitors or Dato-DXd. * Currently pregnant (confirmed with positive pregnancy test), breastfeeding or planning to become pregnant.

Where Is This Study? (10 UK sites)

Research Site

Cardiff CF14 2TL, United Kingdom

Recruiting

Research Site

Chelsea SW3 6JJ, United Kingdom

Recruiting

Research Site

Leicester Le5 4PW, United Kingdom

Recruiting

Research Site

Liverpool L7 8YA, United Kingdom

TERMINATED

Research Site

London EC1A 7BE, United Kingdom

Recruiting

Research Site

London SW17 0QT, United Kingdom

WITHDRAWN

Research Site

Oxford OX3 7LE, United Kingdom

SUSPENDED

Research Site

Surrey GU2 7XX, United Kingdom

SUSPENDED

Research Site

Sutton SM2 5PT, United Kingdom

Recruiting

Research Site

Taunton TA1 5DA, United Kingdom

Recruiting

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com

AstraZeneca Breast Cancer Study Locator Service

Sponsor contact

CONTACT

+1-877-400-4656 az-bcsl@careboxhealth.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09