RecruitingPhase 2NCT07263425

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

Efficacy and Safety of Intrathecal Administration of Thiotepa in Combination With Trastuzumab Via the Ommaya Reservoir in Breast Cancer With Leptomeningeal Metastasis: a Phase II Multicenter Clinical Trial


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

26 participants

Start Date

Oct 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing thiotepa (a chemotherapy drug) injected directly into the fluid around the brain and spine (intrathecal administration) combined with trastuzumab (a targeted therapy) for patients with HER2-positive breast cancer that has spread to the leptomeninges — the thin membranes surrounding the brain and spinal cord — a serious and difficult-to-treat complication. **You may be eligible if...** - You have confirmed HER2-positive breast cancer (tested by biopsy) - Your cancer has spread to the leptomeninges, confirmed by spinal fluid analysis and brain imaging - You have an Ommaya reservoir implanted in your head (or are a candidate for one) — a device that allows drug delivery directly into brain fluid - You have adequate bone marrow, liver, and kidney function **You may NOT be eligible if...** - Your cancer is not HER2-positive - Your cancer has not spread to the leptomeninges - You cannot have an Ommaya reservoir implanted - Your overall condition (KPS below 30) is too poor for treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIntrathecal Administration of Thiotepa in Combination with Trastuzumab via the Ommaya Reservoir

Intrathecal chemotherapy group Patients received intrathecal 150mg Trastuzumab combination with 10mg thiotepa once every three weeks until an event that meets the criteria for termination occurs.


Locations(1)

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

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NCT07263425