RecruitingPhase 2NCT06875128

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


Sponsor

Delcath Systems Inc.

Enrollment

90 participants

Start Date

Jan 29, 2026

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether delivering a high dose of melphalan chemotherapy directly into the liver, combined with standard cancer drug therapy, can shrink tumors better than standard therapy alone in patients with metastatic breast cancer that has spread mainly to the liver. **You may be eligible if...** - You have been diagnosed with metastatic breast cancer that is HER2-negative - Your cancer has spread mainly to the liver - Your hormone receptor-positive disease has already progressed on hormone therapy and CDK 4/6 inhibitor drugs - Your cancer has been previously treated with certain antibody-drug conjugates (ADCs) or you are not eligible for those treatments **You may NOT be eligible if...** - You have severe liver disease or inadequate liver function - You are pregnant - You have had prior pelvic radiation or bone marrow transplant that limits liver treatment - Your general health is too poor for surgery-like procedures 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

DRUGMelphalan/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)

DRUGPhysician's choice of SOC (eribulin, vinorelbine, or capecitabine)

Physician's choice of SOC (eribulin, vinorelbine, or capecitabine)


Locations(2)

Moffitt Cancer Center

Tampa, Florida, United States

Ohio State University, Stefanie Spielman Comprehensive Breast Center

Columbus, Ohio, United States

View Full Details on ClinicalTrials.gov

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NCT06875128