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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
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
Where Is This Study? (10 UK sites)
Research Site
Cardiff CF14 2TL, United Kingdom
Research Site
Chelsea SW3 6JJ, United Kingdom
Research Site
Leicester Le5 4PW, United Kingdom
Research Site
Liverpool L7 8YA, United Kingdom
Research Site
London EC1A 7BE, United Kingdom
Research Site
London SW17 0QT, United Kingdom
Research Site
Oxford OX3 7LE, United Kingdom
Research Site
Surrey GU2 7XX, United Kingdom
Research Site
Sutton SM2 5PT, United Kingdom
Research Site
Taunton TA1 5DA, United Kingdom
How to Get in Touch
AstraZeneca Clinical Study Information Center
Sponsor contactCONTACT
AstraZeneca Breast Cancer Study Locator Service
Sponsor contactCONTACT
