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

Sponsor
Queen Mary University of London
Study ID
NCT06954480
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Datopotamab Deruxtecan (Dato-DXd) — DRUG
    Patients will receive Dato-DXd 6.0mg/kg, which will be administered by infusion on day 1 of each 21-day cycle.
  • Durvalumab — DRUG
    Patients will receive Durva 1120mg, which will be administered by infusion on day 1 of each 21-day cycle.

Study Details

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.

Key Dates

Start date
Oct 27, 2025
Status verified
May 2026
Primary completion
Feb 29, 2028
Completion
Feb 28, 2030

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dato-DXd plus Durva
    In arm A, patients will receive Durvalumab 1120mg plus Dato-DXd 6.0mg/kg.
  • Active Comparator: Arm B - Dato-DXd
    In arm B, patients will receive Dato-DXd 6.0mg/kg.

Primary Outcome Measure

PFS is defined as the time from the date of randomisation to the date of first documented confirmed tumour progression (using RECIST 1.1) or death from any cause, whichever occurs first in all patients. [ Time Frame: PFS is defined as the time from the date of randomisation to date of first documented confirmed disease progression or death, which ever occurs first, assessed on average up to 12 months. ]

Central Contacts

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