Efficacy and Safety of Intrathecal Administration of Thiotepa in Combination With Trastuzumab Via the Ommaya Reservoir in Breast Cancer With Leptomeningeal Metastasis: a Phase II Multicenter Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Evaluate the efficacy and safety of Intrathecal Administration of Thiotepa in Combination with Trastuzumab via the Ommaya Reservoir in Breast Cancer with Leptomeningeal Metastasis

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Histologically or cytologically confirmed HER-2 positive breast cancer (immunohistochemistry indicates HER-2 3+ and/or fluorescence in situ hybridization indicates HER-2 gene amplification)

• Diagnosed with breast cancer with leptomeningeal metastasis based on cerebrospinal fluid cytology combined with central nervous system function and brain imaging findings

• The patient has an Ommaya reservoir implanted or is eligible for implantation

• KPS ≥ 30

• Adequate bone marrow and liver and kidney function reserves: absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, hemoglobin ≥ 90 g/L. International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN. Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN. Total serum bilirubin ≤ 1.5 x ULN (patients with Gilbert's syndrome can be enrolled if total bilirubin \< 3 x ULN). Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN; if the patient has liver metastasis, this criterion is AST and ALT ≤ 5 x ULN.

• Female, aged between 18 and 75 years old

• Left ventricular ejection fraction (LVEF) \> 50%

• Voluntary signing of informed consent form

Locations
Other Locations
China
Jiangsu Provincial People's Hospital
RECRUITING
Nanjing
Contact Information
Primary
Wei Li, Ph.D
real.lw@163.com
025-68307102
Time Frame
Start Date: 2025-10-27
Estimated Completion Date: 2027-10-27
Participants
Target number of participants: 26
Treatments
Experimental: Experimental
Intrathecal chemotherapy group Patients received intrathecal 150mg Trastuzumab combination with 10mg thiotepa once every three weeks until an event that meets the criteria for termination occurs.
Related Therapeutic Areas
Sponsors
Collaborators: The Affiliated Brain Hospital of Nanjing Medical University
Leads: The First Affiliated Hospital with Nanjing Medical University

This content was sourced from clinicaltrials.gov