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Investigating Datopotamab Deruxtecan Plus Durvalumab Versus Datopotamab Deruxtecan in Patients With PDL1-negative Metastatic Triple-negative Breast Cancer

NCT06954480 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-05-22

No results posted yet for this study

Summary

The DIAMOND study is being carried out to evaluate if Datopotamab deruxtecan (Dato-DX) in combination with Durvalumab is more effective than Dato-DXd alone in treating PDL1-negative advanced or metastatic triple negative breast cancer (TNBC). Globally, breast cancer is the most common malignancy in women and the second most common cancer overall. The term TNBC is used to define tumours that do not express oestrogen receptors, progesterone receptors and HER2 receptors. TNBC comprises 10 -15% of all breast cancers. It remains the subtype with poorest outcome and there is a significant need to develop new therapies for this group of patients especially. Moreover, the PDL1-negative tumour has demonstrated no benefit from standard 1st line treatment of chemotherapy plus immune checkpoint inhibitors.

Conditions

Interventions

DRUG

Datopotamab Deruxtecan (Dato-DXd)

Patients will receive Dato-DXd 6.0mg/kg, which will be administered by infusion on day 1 of each 21-day cycle.

DRUG

Durvalumab

Patients will receive Durva 1120mg, which will be administered by infusion on day 1 of each 21-day cycle.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Queen Mary University of London

    lead OTHER

Principal Investigators

  • Peter Schmid, MD PhD, FRCP · Queen Mary University of London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-27
Primary Completion
2028-02-29
Completion
2030-02-28

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06954480 on ClinicalTrials.gov