OncoMatch/Clinical Trials/NCT06230055
Intrathecal Chemotherapy Through Ommaya Reservoir Upon Her-2 Negative Breast Cancer With Leptomeningeal Metastasis
Is NCT06230055 recruiting? Yes, currently enrolling (May 2026). This Phase 4 trial studies multiple treatments including Ommaya reservoir and Systematic chemotherapy for her2-negative breast cancer.
Treatment: Ommaya reservoir · Systematic chemotherapy · Intrathecal chemotherapy — This is a prospective, multicenter, randomized controlled, open-label investigator-initiated clinical study to evaluate the clinical efficacy and quality of life of intrathecal chemotherapy through Ommaya reservoir in combination with systematic chemotherapy versus systemic chemotherapy alone in patients with Her-2 negative breast cancer with leptomeningeal metastasis.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative (ihc 0 or 1+, or ihc 2+ with negative ish)
Disease stage
Metastatic disease required
Performance status
ECOG 0–3(Limited self-care)
Lab requirements
Blood counts
Platelet count ≥80×10^9/L; Hemoglobin ≥8g/L; Neutrophil count ≥1.5×10^9/L; INR and APTT ≤1.5×ULN
Kidney function
Serum creatinine ≤1.5×ULN
Liver function
ALT and AST ≤ 3×ULN (if liver metastases are present, ALT and AST ≤ 5×ULN); Serum total bilirubin ≤1.5×ULN
Cardiac function
NYHA cardiac function grade ≤II, no obvious abnormality in ECG, or no clinical significance according to the investigators
The function of major organs was good, which was confirmed by the following laboratory tests during the screening period: Platelet count ≥80*10^9/L, Hemoglobin ≥8g/L, Neutrophil count ≥1.5*10^9/L, Serum creatinine ≤1.5*ULN, ALT and AST≤ 3*ULN (if liver metastases are present, ALT and AST≤5*ULN), Serum total bilirubin ≤1.5*ULN, INR and APTT ≤1.5*ULN; NYHA cardiac function grade ≤II, no obvious abnormality in ECG, or no clinical significance according to the investigators
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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