OncoMatch/Clinical Trials/NCT07205822
A Study of Dato-DXd in Inoperable or Metastatic Hormone Receptor-positive, HER2 IHC 0 Breast Cancer
Is NCT07205822 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Dato-DXd for breast cancer.
Treatment: Dato-DXd — A study to assess the efficacy and safety of Dato-DXd in the pre-chemotherapy setting for patients with metastatic HR-positive, HER2 IHC 0 breast cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (ER ≥ 1%)
HR-positive (either ER and/or PgR positive [ER or PgR ≥ 1%])
Required: PR (PGR) overexpression (PgR ≥ 1%)
HR-positive (either ER and/or PgR positive [ER or PgR ≥ 1%])
Required: HER2 (ERBB2) IHC 0 (IHC 0 (no staining or incomplete and faint/barely perceptible membrane staining in ≤ 10% of tumour cells))
HER2 IHC 0 (defined as no staining or incomplete and faint/barely perceptible membrane staining in ≤ 10% of tumour cells)
Disease stage
Metastatic disease required
Inoperable or metastatic HR-positive, HER2 IHC 0 breast cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: endocrine therapy
Progressed on and not suitable for further endocrine therapy per investigator assessment.
Cannot have received: TROP2-targeted therapy
Any TROP2-targeted therapy
Cannot have received: topoisomerase I inhibitor (including ADCs)
Any treatment (including ADC) containing a chemotherapeutic agent targeting topoisomerase I
Cannot have received: chemotherapy
Exception: in the metastatic setting
Any chemotherapy in the metastatic setting
Lab requirements
Blood counts
Haemoglobin ≥ 9.0 g/dL (no transfusion within 1 week prior to screening); ANC ≥ 1.5×10^9/L (no G-CSF within 1 week prior to screening); Platelet count ≥ 100×10^9/L (no platelet transfusion within 1 week prior to screening); Serum albumin ≥ 2.5 g/dL
Kidney function
Calculated CrCL ≥ 30 mL/min as determined by Cockcroft Gault (using actual body weight)
Liver function
TBL ≤ 1.5 × ULN or ≤ 3 × ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinaemia); ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN with hepatic metastases); see Exclusion Criterion 8 for requirements in the setting of HBV.
Adequate bone marrow reserve and organ function within 7 days before the first dose of study intervention. See detailed criteria.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Research Site · Largo, Florida
- Research Site · Fort Wayne, Indiana
- Research Site · Omaha, Nebraska
- Research Site · New York, New York
- Research Site · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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