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

NCT06230055 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2025-11-25

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Ommaya reservoir

Intrathecal chemotherapy through Ommaya reservoir

DRUG

Systematic 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).

DRUG

Intrathecal 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).

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-05
Primary Completion
2026-01-01
Completion
2027-01-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06230055 on ClinicalTrials.gov