RecruitingPhase 2NCT06954480

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

An Open-label Randomised, Phase II Trial of Datopotamab Deruxtecan Plus Durvalumab Versus Datopotamab Deruxtecan in Patients With PDL1-negative Metastatic Triple-negative Breast Cancer


Sponsor

Queen Mary University of London

Enrollment

140 participants

Start Date

Oct 27, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two treatment combinations for women with triple-negative breast cancer (TNBC) that has spread to other parts of the body and whose tumors do not respond well to immunotherapy (PD-L1 negative). Researchers are testing whether adding an immunotherapy drug (durvalumab) to a new antibody-drug combination (datopotamab deruxtecan) improves outcomes compared to the antibody-drug alone. **You may be eligible if...** - You are a female aged 18 or older - Your breast cancer is triple-negative (no estrogen receptor, no progesterone receptor, no HER2 amplification) - Your tumor tests negative for PD-L1 (a marker used to predict immunotherapy response) - You have at least one measurable tumor that has not been previously irradiated - You have tumor tissue available for central testing **You may NOT be eligible if...** - Your tumor is not triple-negative - You have sclerotic (hardening) bone lesions only with no measurable soft tissue disease - You cannot be assessed by CT or MRI Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDatopotamab 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.

DRUGDurvalumab

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


Locations(2)

Barts Cancer Institute, Centre of Experimental Cancer Medicine

London, United Kingdom

Barts Health NHS Trust

London, United Kingdom

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NCT06954480


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