RecruitingPhase 1Phase 2NCT06462092

Sacituzumab Govitecan and Intrathecal Chemotherapy for Treating Leptomeningeal Metastases From Her2-negative Breast Cancer

A Phase I/II Clinical Study of Sacituzumab Govitecan Combined With Intrathecal Chemotherapy for the Treatment of Leptomeningeal Metastases From Her2-negative Breast Cancer


Sponsor

Guangzhou Medical University

Enrollment

34 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Leptomeningeal metastases (LM) is a lethal complication of malignant tumors, characterized by tumor cell invasion and proliferation within the subarachnoid space. LM from HER2-negative breast cancer remains challenging to treat, with a median overall survival of only 3-6 months despite aggressive therapy. This open-label, uncontrolled Phase I/II clinical study aims to evaluate the safety, feasibility, and potential efficacy of Sacituzumab Govitecan in combination with intrathecal pemetrexed chemotherapy for LM from HER2-negative breast cancer, with the objective of identifying a more effective treatment strategy.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial tests sacituzumab govitecan (a targeted chemotherapy drug) combined with chemotherapy injected directly into the spinal fluid to treat leptomeningeal metastases — cancer that has spread to the fluid and membranes surrounding the brain and spinal cord — in patients with HER2-negative breast cancer. **You may be eligible if...** - You are 18 or older with confirmed HER2-negative breast cancer (IHC 0, 1+, or 2+/ISH-negative) - Cancer cells have been found in your spinal fluid (CSF), or imaging and symptoms strongly suggest leptomeningeal spread - Your major organ function is adequate **You may NOT be eligible if...** - You have poor blood counts (low white cells, platelets, or hemoglobin) - You have significant liver dysfunction - You are HIV-positive or have serious immune deficiency - You are pregnant or breastfeeding - You are unwilling to use contraception if of childbearing potential 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

DRUGSacituzumab Govitecan

Patients receive Sacituzumab Govitecan 10mg/kg by intravenous infusion on days 1 and 8. Treatment cycles are every 21 days.

DRUGPemetrexed

Intrathecal pemetrexed chemotherapy, administered via intracerebroventricular or lumbar puncture, consists of three phases: induction therapy (15 mg twice weekly for 2 weeks), consolidation therapy (once weekly for 4 consecutive weeks), and maintenance therapy (once monthly).


Locations(1)

The Affiliated Huizhou Hospital, Guangzhou Medical University

Huizhou, Guangdong, China

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NCT06462092


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