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

Phase 4 Recruiting 37 enrolled Fudan University

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

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

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cytarabine	Small molecule	30 mg/m2	Intrathecal
Subject	Cytarabine	Small molecule	50 mg	Intrathecal
Subject	MTX	Unknown	—	Intrathecal
Subject	Pemetrexed	Small molecule	50 mg	Intrathecal
Subject	Thiotepa	Other / unclassified	10 mg	Intrathecal
Subject	Trastuzumab deruxtecan	Monoclonal antibody	5.4 mg/kg	Intravenous
Background	Capecitabine	Small molecule	1000 mg/m2	Oral
Background	Docetaxel	Small molecule	75 mg/m2	Intravenous
Background	Gemcitabine	Small molecule	1000 mg/m2	Intravenous
Background	Paclitaxel	Small molecule	125 mg/m2	Intravenous
Background	Sacituzumab Govitecan	Monoclonal antibody	10 mg/kg	Intravenous
Background	Sacituzumab Tirumotecan	Other / unclassified	5 mg/kg	Intravenous
Background	Vinorelbine	Small molecule	60 mg/m2	Oral
Background	iribrin	Unknown	1.4 mg/m2	Intravenous

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

Summary

Timeline

Drugs

Indications