OncoMatch/Clinical Trials/NCT05800275
Capecitabine, Tucatinib, and Intrathecal Trastuzumab for Breast Cancer Patients With Leptomeningeal Disease
Is NCT05800275 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Tucatinib Oral Tablet and Capecitabine tablets for leptomeningeal metastasis.
Treatment: Tucatinib Oral Tablet · Capecitabine tablets · Trastuzumab — The goal of this clinical trial is to evaluate the efficacy of tucatinib and capecitabine in combination with intrathecal trastuzumab on overall survival rate at 12 months in HER2-positive metastatic breast cancer (MBC) patients with proven leptomeningeal evolution and requiring intrathecal therapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: HER2-targeted therapy (tucatinib)
Previous treatment with Tucatinib
Cannot have received: antimetabolite (capecitabine)
Previous treatment with Capecitabine
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥1.5 x 10⁹/L; platelets count ≥100 x 10⁹/L; and hemoglobin ≥9.0 g/dL
Kidney function
estimated creatinine clearance ≥60 mL/min according to the Cockcroft-Gault formula
Liver function
total bilirubin ≤1.5 ULN (unless documented Gilbert's syndrome); AST and ALT ≤2.5 ULN (≤5 ULN in the presence of liver metastases)
Cardiac function
12 Lead ECG with normal tracing or non-clinically significant changes; QT/QTc interval ≤470 msec for women and ≤450 msec for men; LVEF ≥55%; No history of Torsades de Pointes or other symptomatic QTc abnormality
Adequate hematological function within 14 days before inclusion: Absolute neutrophil count (ANC) ≥1.5 x 10⁹/L; platelets count ≥100 x 10⁹/L; and hemoglobin ≥9.0 g/dL; Adequate liver function within 14 days before inclusion: total bilirubin ≤1.5 ULN (unless documented Gilbert's syndrome); AST and ALT ≤2.5 ULN (≤5 ULN in the presence of liver metastases); Normal renal function within 14 days before inclusion: estimated creatinine clearance ≥60 mL/min according to the Cockcroft-Gault formula; Adequate cardiac function: 12 Lead ECG with normal tracing or non-clinically significant changes that do not require medical intervention; QT/QTc interval ≤470 msec for woman and ≤450 msec for men (mean of replicate values, correction per institutional standard) on the ECG at the screening visit and a normal kaliemia; Left ventricular ejection fraction (LVEF) ≥55%; No history of Torsades de Pointes or other symptomatic QTc abnormality
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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