RecruitingPhase 4NCT06230055

Intrathecal Chemotherapy Through Ommaya Reservoir Upon Her-2 Negative Breast Cancer With Leptomeningeal Metastasis

Clinical Outcome and Quality of Life of Intrathecal Chemotherapy Through Ommaya Reservoir in Combination With Systematic Chemotherapy Versus Systematic Chemotherapy Upon Her-2 Negative Breast Cancer With Leptomeningeal Metastasis (CONQUER)


Sponsor

Fudan University

Enrollment

37 participants

Start Date

Jan 5, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, multicenter, randomized controlled, open-label investigator-initiated clinical study to evaluate the clinical efficacy and quality of life of intrathecal chemotherapy through Ommaya reservoir in combination with systematic chemotherapy versus systemic chemotherapy alone in patients with Her-2 negative breast cancer with leptomeningeal metastasis.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a chemotherapy regimen delivered directly into the fluid around the brain and spinal cord (called intrathecal chemotherapy, via an Ommaya reservoir surgically placed under the scalp) for patients with HER2-negative breast cancer that has spread to the lining of the brain (leptomeningeal metastasis). **You may be eligible if...** - You are 18 or older with confirmed HER2-negative metastatic breast cancer - Cancer cells have been found in your cerebrospinal fluid, or imaging and symptoms suggest spread to the brain lining - You have not responded to or cannot tolerate standard treatments - Your ECOG performance status is 3 or less **You may NOT be eligible if...** - Your breast cancer is HER2-positive - You have not yet tried standard treatments - You have uncontrolled infections or other serious medical conditions - Your organ function does not meet the required thresholds 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

DEVICEOmmaya reservoir

Intrathecal chemotherapy through Ommaya reservoir

DRUGSystematic chemotherapy

Systematic chemotherapy: including capecitabine(1000mg/m2 bid, d1-14, q3w, po), gemcitabine(1000mg/m2, d1,8, q3w, ivgtt), vinorelbine(60mg/m2, qw, po), docetaxel(75mg/m2, d1, q3w, ivgtt),Nab-paclitaxel(125mg/m2, d1,8, q3w, ivgtt), iribrin(1.4mg/m2, d1,8, q3w, ivgtt), DS8201(5.4mg/kg, d1, q3w, ivgtt), sacituzumab govitecan(10mg/kg, d1,8, q3w, ivgtt) or SKB264(5mg/kg, d1, q2w, ivgtt).

DRUGIntrathecal chemotherapy

Intrathecal chemotherapy through Ommaya reservoir: including MTX(10-12mg, q1-3w), thiotepa(10mg, q1-3w), cytarabine(30mg/m2, q1-3w), cytarabine liposome(50mg, q1-3w), pemetrexed(50mg, q1-3w), or DS8201(The frequency and cycle of drug administration are determined based on the results of the Phase I/II clinical trial of intrathecal injection of DS8201 in our center).


Locations(1)

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

Shanghai, Shanghai Municipality, China

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NCT06230055


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