Efficacy and Safety of Intrathecal Administration of Thiotepa in Combination With Methotrexate in Breast Cancer With Leptomeningeal Metastasis

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

Evaluate the efficacy and safety of Intrathecal Administration of Thiotepa in Combination with Methotrexate via the Ommaya Reservoir in Breast Cancer with Leptomeningeal Metastasis

Eligibility criteria

Qualifiers

Patient is an adult female ≥18 and ≤75 years old at the time of informed consent.

ECGO rating 0-3.

Histologically or cytologically confirmed breast cancer.

Cerebrospinal fluid cytology combined with central nervous system function and brain imaging demonstrated the diagnosis of breast cancer with meningeal metastases;

Disqualifiers

Patients with other malignant tumors, excluding basal cell carcinoma and carcinoma in situ

Patients with severe or uncontrolled systemic disease, including uncontrolled hypertension or active bleeding tendency

The investigator considers the patient unsuitable for entry into this study.

Patients with toxicity from prior therapy that has not returned to normal or NCI-CTCAE grade 5.0

Trial design

Treatments tested in this trial

  • Intrathecal Administration of Thiotepa in Combination with Methotrexate via the Ommaya Reservoir

Treatment groups

22 Participants
are divided into 1 treatment group

Sponsors and collaborators

The First Affiliated Hospital with Nanjing Medical University

Lead sponsor

The Affiliated Brain Hospital of Nanjing Medical University

Collaborator