OncoMatch/Clinical Trials/NCT06508216
A Study to Explore Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of Novel Therapeutics in Patients With Early Relapsed Metastatic Triple-negative Breast Cancer
Is NCT06508216 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Dato-DXd and Durvalumab for breast cancer.
Treatment: Dato-DXd · Durvalumab — Choice Of the Most Active Strategies for Short term recurring Triple Negative Breast Cancer: A phase Ib/II, open-label, modular, dose-finding and dose-expansion study to explore safety, tolerability, pharmacokinetics, and anti-tumor activity of novel therapeutics in patients with early relapsed metastatic triple-negative breast cancer
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative (IHC 0, 1+ or IHC 2+/ISH-) (IHC 0, 1+ or IHC 2+/ISH-)
HER2-negative (IHC 0, 1+ or IHC 2+/ISH-) based on local assessment according to ASCO/CAP guidelines
Required: ESR1 negative (<10%) (<10%)
oestrogen receptors and progesterone receptors are negative [oestrogen receptors and progesterone receptors < 10%]
Required: PR (PGR) negative (<10%) (<10%)
oestrogen receptors and progesterone receptors are negative [oestrogen receptors and progesterone receptors < 10%]
Allowed: BRCA1 germline pathogenic mutation
Patients with germinal pathological BRCA1/2 mutations are eligible to the study if they have received prior treatment with PARP inhibitor
Allowed: BRCA2 germline pathogenic mutation
Patients with germinal pathological BRCA1/2 mutations are eligible to the study if they have received prior treatment with PARP inhibitor
Disease stage
Metastatic disease required
Advanced/unresectable (patients who can be treated with curative intent are not eligible) or metastatic
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: chemotherapy — neo/adjuvant
Patients who have received neo/adjuvant chemotherapy in the localized stage. Radiological and anatomopathological evidence of disease recurrence or metastasis while on (neo)adjuvant treatment or within 12 months from the end of all treatments with curative intent.
Cannot have received: antibody-drug conjugate (Sacituzumab govitecan)
Patients having received prior treatment with any antibody drug conjugates targeting TROP2 (eg, Sacituzumab govitecan) are not eligible to the study.
Lab requirements
Blood counts
adequate organ and bone marrow function within 14 days prior to treatment assignment
Kidney function
adequate organ and bone marrow function within 14 days prior to treatment assignment
Liver function
adequate organ and bone marrow function within 14 days prior to treatment assignment
Cardiac function
lvef ≥ 50% within 28 days before enrolment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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