Brain-Lining cancer in breast cancer patients: could a reservoir pump chemo directly to the target?

NCT ID NCT06230055

First seen Jun 27, 2026 ยท Last updated Jun 27, 2026

Summary

This study is for people with HER2-negative breast cancer that has spread to the lining of the brain (leptomeningeal metastasis). It compares standard chemotherapy given through the veins or by mouth to the same treatment plus extra chemotherapy delivered directly into the spinal fluid through a small device called an Ommaya reservoir, which is placed under the scalp. The goal is to see if the combination helps control the brain lining cancer longer and improves quality of life. About 37 participants will be randomly assigned to one of the two groups.

What this could mean

Our plain-language read of the trial. This is informational only โ€” not medical advice or a prediction.

Active substance
Chemotherapy drugs (e.g., methotrexate) given through an Ommaya reservoir into the spinal fluid, plus standard systemic chemotherapy
What this could lead to
If it works, this approach could offer better control of cancer spread to the brain lining and improve quality of life for patients with this difficult-to-treat condition.
What could go wrong
This is a small, early-phase trial with only 37 participants, so results may not apply to everyone. The added procedure carries risks like infection or bleeding, and the benefit over standard care is not yet proven.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Fudan University Shanghai Cancer Center; Department of Oncology, Shanghai Medical College, Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

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