Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT06954480

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

Led by Queen Mary University of London · Updated on 2025-11-19

140

Participants Needed

2

Research Sites

222 weeks

Total Duration

On this page

Sponsors

Q

Queen Mary University of London

Lead Sponsor

A

AstraZeneca

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Willing and able to provide written informed consent.
  • Able to comply with the study protocol.
  • Female aged 18 years or older.
  • Triple-negative breast cancer defined by low or no estrogen receptor, progesterone receptor, and HER2 expression.
  • PDL1-negative tumor defined as a combined positive score less than 10.
  • At least one measurable lesion not previously irradiated or specific bone lesions.
  • Availability of representative tumor tissue samples or accessible tumor for biopsy.
  • ECOG performance status of 0 or 1.
  • Life expectancy of at least 12 weeks.
  • Adequate blood counts and organ function within 28 days before first treatment.
  • Negative pregnancy test for women of childbearing potential and agreement to use effective contraception.
  • Body weight greater than 30 kg.
Not Eligible

You will not qualify if you...

  • Prior chemotherapy, immunotherapy (including durvalumab) or PARP inhibitors for advanced/metastatic breast cancer.
  • Prior immune checkpoint inhibitors or targeted therapies within 6 months before randomization.
  • History of stem cell or solid organ transplantation.
  • Diagnosis of immunodeficiency or use of high-dose chronic steroids.
  • Live vaccine administration within 30 days before first dose.
  • Active or prior autoimmune or inflammatory disorders except certain stable conditions.
  • History of lung diseases requiring steroids or active pneumonitis.
  • Active infections needing systemic therapy.
  • History of HIV or active hepatitis B or C infection.
  • Active tuberculosis.
  • Any condition that may increase risk or interfere with study participation.
  • Psychological, social, or geographical factors preventing protocol compliance.
  • Participation in other clinical trials with therapeutic intent within 28 days.
  • Pregnant or breastfeeding women.
  • Recent major surgery within 4 weeks before randomization.
  • Other cancers within 5 years except certain low-risk types.
  • Severe infections within 28 days before randomization.
  • Unresolved significant toxicity from prior cancer treatments.
  • Uncontrolled illness including heart failure, hypertension, or serious chronic conditions.
  • History of leptomeningeal carcinomatosis.
  • Significant corneal disease or severe hypersensitivity to monoclonal antibodies.
  • Active primary immunodeficiency.
  • Allergy to study drugs or excipients.
  • Brain metastases or spinal cord compression unless stable and meeting specific criteria.
  • Prolonged QT interval on ECG.
  • Prior anti-PD-1, PD-L1, or CTLA-4 therapy with serious immune-related adverse events or ongoing immunosuppression requirements.

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Barts Cancer Institute, Centre of Experimental Cancer Medicine

London, United Kingdom, EC1M 6BQ

Not Yet Recruiting

2

Barts Health NHS Trust

London, United Kingdom

Actively Recruiting

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Research Team

P

Peter Schmid, MD PhD, FRCP

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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