DIAMOND
Research type
Research Study
Full title
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
IRAS ID
1011098
Contact name
Peter Schmid
Contact email
Sponsor organisation
Queen Mary University of London
ISRCTN Number
ISRCTN67463316
Clinicaltrials.gov Identifier
Research summary
This study is being carried out to see if Datopotamab deruxtecan in combination with Durvalumab is effective than Datopotamab deruxtecan alone in treating PDL1-negative advanced or metastatic triple negative breast cancer (TNBC).
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.
Datopotamab deruxtecan is an antibody drug conjugate (ADC) that targets tumour-associated calcium signal transducer 2, TROP2, a transmembrane protein that is highly expressed in various epithelial tumors including breast cancer. Durvalumab is an immune checkpoint inhibitor and is expected to stimulate the patient’s antitumour immune response by binding to PD-L1 and shifting the balance toward an antitumour response. The preclinical and clinical evidence have suggested synergistic activity between antibody drug conjugate and immune checkpoint inhibitor.
This study will recruit 140 patients, aged 18 and over and consenting patients will be randomly placed into one of two treatment groups. One group will receive Datopotamab deruxtecan in combination with Durvalumab and the other groups will receive Datopotamab deruxtecan alone. Treatment will continue unless there is evidence of unacceptable toxicity, disease progression, or if the patient requests to stop the treatment or death.
Safety and tolerability as well as progression free survival, overall survival, clinical benefit rate, duration of response and duration of clinical benefit and quality of life will be assessed.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
25/SC/0166
Date of REC Opinion
17 Jun 2025
REC opinion
Further Information Favourable Opinion