NCT06875128

Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Breast Cancer w/Liver Dominant Disease

An Open-label, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of Induction Treatment With Melphalan/HDS Followed by Consolidation Treatment With Eribulin or Vinorelbine or Capecitabine Versus Eribulin or Vinorelbine or Capecitabine Alone in Patients With Metastatic Breast Cancer With Liver Dominant Disease

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Delcath Systems Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if using a liver-directed therapy with high dose chemotherapy followed by approved cancer treatment to treat patients with breast cancer that has spread to the liver is safe and tolerable. The clinical trial will also learn if the liver-directed therapy with high dose chemotherapy works on the disease in the liver. Investigators will compare the use of the liver-directed therapy with high dose chemotherapy followed by approved cancer treatment or approved cancer treatment alone. Participants will: * Undergo up to two cycles of liver-directed therapy with high dose chemotherapy procedures followed by approved cancer treatment or take approved cancer treatment alone * Visit clinic at least every two weeks for checkups and tests * Complete scans approximately every 8 weeks

Conditions

• Metastatic Breast Cancer in the Liver

Interventions

Type	Name	Description
DRUG	Melphalan/HDS followed by Physician's choice of SOC (eribulin, vinorelbine, or capecitabine)	Melphalan/HDS followed by Physician's choice of SOC (eribulin, vinorelbine, or capecitabine)
DRUG	Physician's choice of SOC (eribulin, vinorelbine, or capecitabine)	Physician's choice of SOC (eribulin, vinorelbine, or capecitabine)

Timeline

• Start date: 2026-01-29
• Primary completion: 2029-05-01
• Completion: 2029-08-01
• First posted: 2025-03-13
• Last updated: 2026-03-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study