OncoMatch/Clinical Trials/NCT06954480
Investigating Datopotamab Deruxtecan Plus Durvalumab Versus Datopotamab Deruxtecan in Patients With PDL1-negative Metastatic Triple-negative Breast Cancer
Is NCT06954480 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Datopotamab Deruxtecan (Dato-DXd) and Durvalumab for triple negative breast cancer.
Treatment: Datopotamab Deruxtecan (Dato-DXd) · Durvalumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: ESR1 negative for ER (<10% IHC or Allred ≤3) (<10% IHC or Allred ≤3)
Negative for ER with <10% of tumour cells positive for ER on IHC or IHC score (Allred) of ≤3.
Required: PR (PGR) negative for PR (<10% IHC or Allred ≤3 or PR unknown) (<10% IHC or Allred ≤3 or PR unknown)
Negative for PR with <10% of tumour cells positive for PR on IHC or IHC score (Allred) of ≤3 or PR unknown
Required: HER2 (ERBB2) negative for HER2 (0, 1+ or 2+ IHC and no amplification on ISH) (0, 1+ or 2+ IHC and no amplification on ISH)
Negative for HER2 with 0, 1+ or 2+ intensity on IHC and no evidence of amplification on ISH.
Required: PD-L1 (CD274) PD-L1 negative (22C3 CPS<10) (22C3 CPS<10)
PDL1 negative, defined as 22C3 CPS<10.
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Exception: for advanced or metastatic breast cancer
Prior chemotherapy, immunotherapy (including durvalumab) or treatment with PARP inhibitors for advanced or metastatic breast cancer.
Cannot have received: immunotherapy (durvalumab)
Exception: for advanced or metastatic breast cancer
Prior chemotherapy, immunotherapy (including durvalumab) or treatment with PARP inhibitors for advanced or metastatic breast cancer.
Cannot have received: PARP inhibitor
Exception: for advanced or metastatic breast cancer
Prior chemotherapy, immunotherapy (including durvalumab) or treatment with PARP inhibitors for advanced or metastatic breast cancer.
Cannot have received: immune checkpoint inhibitor (atezolizumab, pembrolizumab)
Prior treatment with immune checkpoint inhibitors (eg atezolizumab, pembrolizumab) or DNA topoisomerase I or TROP2- or HER2-targeting ADCs and TROP2 targeted therapy in the (neo)adjuvant setting within 6 months from the end of treatment and randomisation into this study.
Cannot have received: DNA topoisomerase I inhibitor
Exception: in the (neo)adjuvant setting within 6 months from the end of treatment and randomisation
Prior treatment with immune checkpoint inhibitors (eg atezolizumab, pembrolizumab) or DNA topoisomerase I or TROP2- or HER2-targeting ADCs and TROP2 targeted therapy in the (neo)adjuvant setting within 6 months from the end of treatment and randomisation into this study.
Cannot have received: TROP2-targeted therapy
Exception: in the (neo)adjuvant setting within 6 months from the end of treatment and randomisation
Prior treatment with immune checkpoint inhibitors (eg atezolizumab, pembrolizumab) or DNA topoisomerase I or TROP2- or HER2-targeting ADCs and TROP2 targeted therapy in the (neo)adjuvant setting within 6 months from the end of treatment and randomisation into this study.
Cannot have received: HER2-targeted therapy
Exception: in the (neo)adjuvant setting within 6 months from the end of treatment and randomisation
Prior treatment with immune checkpoint inhibitors (eg atezolizumab, pembrolizumab) or DNA topoisomerase I or TROP2- or HER2-targeting ADCs and TROP2 targeted therapy in the (neo)adjuvant setting within 6 months from the end of treatment and randomisation into this study.
Lab requirements
Blood counts
ANC ≥ 1500/μL; WBC > 2500/μL; Platelet count ≥ 100,000/μL; Haemoglobin ≥ 9.0 g/dL; Serum albumin ≥ 3g/dL
Kidney function
Serum Creatinine ≤ 1.5 x ULN; GFR ≥ 40 mL/min
Liver function
AST (SGOT) or ALT (SGPT) and ALP ≤ 2.5 x ULN, bilirubin ≤ 1.5 x ULN (≤ 5 x ULN for AST/ALT with liver metastases)
Cardiac function
Mean QTcF < 470 ms (from 3 ECGs within 15 minutes at 5 minutes apart)
Adequate haematologic and end-organ function within 28 days prior to the first study treatment defined by the following: Absolute neutrophil count ≥ 1500 cells/μL... Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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