OncoMatch/Clinical Trials/NCT06176261
DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs
Is NCT06176261 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Datopotamab Deruxtecan for breast cancer.
Treatment: Datopotamab Deruxtecan — The purpose of this study is to test the safety and effectiveness of the study drug datopotamab deruxtecan in participants with metastatic breast cancer that has spread to the brain. The name of the study drug used in this research study is: Datopotamab deruxtecan (a type of antibody-drug conjugate)
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Triple-Negative Breast Cancer
Biomarker criteria
Required: HER2 (ERBB2) HER2-negative (HER2-negative according to 2018 ASCO/CAP guidelines)
HER2-negative according to 2018 ASCO/CAP guidelines
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: endocrine therapy — metastatic
Cohort A: prior progression to treatment with at least one line of endocrine treatment (with or without CDK4/6 inhibition) in the metastatic setting is mandatory. Patients experiencing recurrence during adjuvant endocrine treatment will be also considered eligible for the trial.
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL (no transfusion within 1 week prior to screening); Absolute neutrophil count ≥1,500/mm3 (no G-CSF within 1 week prior); Platelets ≥100,000/mm3 (no platelet transfusion within 1 week prior)
Kidney function
Serum creatinine ≤ 1.5 mg/dL (or glomerular filtration rate ≥ 30 ml/min as determined by the Cockcroft-Gault equation)
Liver function
Total bilirubin ≤ 1.5 institutional ULN if no liver metastases; or ≤ 3 x ULN in the presence of documented Gilbert's syndrome or liver metastases at baseline. AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional ULN OR ≤ 5.0 x institutional ULN for patients with documented liver metastases.
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan
Adequate organ function as defined by the following values: Hemoglobin ≥ 9.0 g/dL... Platelets ≥100,000/mm3... Total bilirubin ≤ 1.5 institutional ULN if no liver metastases; or ≤ 3 x ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline. AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional ULN OR ≤ 5.0 x institutional ULN for patients with documented liver metastases. Serum creatinine ≤ 1.5 mg/dL (or glomerular filtration rate ≥ 30 ml/min as determined by the Cockcroft-Gault equation). Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Miami Baptist Cancer Institute/ · Miami, Florida
- Dana-Farber Cancer Institute · Boston, Massachusetts
- Duke University Medical Center · Durham, North Carolina
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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