Actively Recruiting
Efficacy and Safety of Intrathecal Administration of Thiotepa in Combination With Trastuzumab in Breast Cancer With Leptomeningeal Metastasis
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-12-04
26
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital with Nanjing Medical University
Lead Sponsor
T
The Affiliated Brain Hospital of Nanjing Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Evaluate the efficacy and safety of Intrathecal Administration of Thiotepa in Combination with Trastuzumab via the Ommaya Reservoir in Breast Cancer with Leptomeningeal Metastasis
CONDITIONS
Official Title
Efficacy and Safety of Intrathecal Administration of Thiotepa in Combination With Trastuzumab in Breast Cancer With Leptomeningeal Metastasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed HER-2 positive breast cancer (immunohistochemistry indicates HER-2 3+ and/or fluorescence in situ hybridization indicates HER-2 gene amplification)
- Diagnosed with breast cancer with leptomeningeal metastasis based on cerebrospinal fluid cytology combined with central nervous system function and brain imaging findings
- Patient has an Ommaya reservoir implanted or is eligible for implantation
- Karnofsky Performance Status (KPS) of 30 or higher
- Adequate bone marrow and liver and kidney function: absolute neutrophil count (ANC) 21 1.5 x 10^9/L, platelets 21 100 x 10^9/L, hemoglobin 21 90 g/L; INR or prothrombin time (PT) 2c 1.5 x upper limit normal (ULN); activated partial thromboplastin time (aPTT) 2c 1.5 x ULN; total serum bilirubin 2c 1.5 x ULN (patients with Gilbert's syndrome can be enrolled if total bilirubin < 3 x ULN); AST and ALT 2c 2.5 x ULN or 2c 5 x ULN if liver metastasis present
- Female, aged between 18 and 75 years old
- Left ventricular ejection fraction (LVEF) greater than 50%
- Voluntary signing of informed consent form
You will not qualify if you...
- Presence of other malignant tumors, excluding skin basal cell carcinoma and carcinoma in situ
- Presence of severe or uncontrollable systemic diseases, including uncontrollable hypertension or active bleeding tendency
- Patients judged by the investigator to be unsuitable for participation in the trial or factors that may affect protocol compliance
- Toxicity from previous treatment has not returned to normal or is grade 1 according to NCI-CTCAE 5.0
- Allergy or metabolic disorders related to the study drugs
- Pregnant or breastfeeding women, or women planning pregnancy during the study and within 6 months after last treatment
- Participation in other clinical studies at the same time
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Research Team
W
Wei Li, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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