Actively Recruiting
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
Led by Delcath Systems Inc. · Updated on 2026-03-13
90
Participants Needed
2
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of metastatic breast cancer (MBC).
- HER2-negative MBC, including triple negative disease.
- Hormone receptor-positive patients must have progressed on or be intolerant of prior endocrine therapy and CDK 4/6 inhibitors.
- Disease progression after treatment with TOPO-1 isomerase inhibitor antibody-drug conjugates (ADCs) like sacituzumab govitecan or trastuzumab deruxtecan, or prior treatment with two standard chemotherapy regimens if ADCs are unavailable.
- Suitable for single agent chemotherapy with eribulin, vinorelbine, or capecitabine.
- Liver-dominant metastatic disease defined as majority of tumor burden or life-threatening disease in the liver.
- Liver metastases involve 50% or less of liver parenchyma.
- Limited extrahepatic metastatic disease with liver as life-threatening site.
- Measurable liver disease by CT or MRI per RECIST v1.1.
- Patient weighs 35 kg or more.
- CT scans of chest, abdomen, pelvis and MRI of liver within 28 days prior to randomization.
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1.
You will not qualify if you...
- Prior chemoembolization, radioembolization, or hepatic arterial infusion therapy to the liver.
- Significant portal hypertension or history of varices.
- New York Heart Association class II-IV or active serious cardiac conditions.
- Clinically significant pulmonary disease preventing general anesthesia.
- History of bleeding disorders, brain metastases, or intracranial abnormalities increasing bleeding risk.
- Known varices at risk of bleeding, active peptic ulcer, or recent hemoptysis.
- Active second malignancy or recent invasive cancer treated within 2 years (exceptions for certain skin and thyroid cancers).
- Symptoms indicating significant disease progression such as spinal cord compression or symptomatic pleural effusion.
- Pregnant or breastfeeding.
- Women of childbearing potential unable to undergo hormonal suppression to avoid menstruation during treatment.
- Chronic use of immunosuppressive drugs (except low dose steroids).
- Inability to stop chronic anti-coagulation therapy temporarily.
- Active bacterial or viral infections with systemic symptoms.
- Severe allergic reactions to iodine contrast or melphalan system components.
- Known latex allergy or heparin hypersensitivity.
- Uncontrolled endocrine disorders.
- Recent anti-cancer treatment or investigational agent within 30 days prior to randomization.
- Not recovered from prior treatment side effects to Grade 1 or less (with some exceptions).
- Less than 28 days after surgery with unhealed wound.
- Current treatment for cancer other than MBC or not cancer-free.
- Not eligible for eribulin, vinorelbine, or capecitabine.
- Albumin level below 3.0 g/dL.
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Trial Site Locations
Total: 2 locations
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
2
Ohio State University, Stefanie Spielman Comprehensive Breast Center
Columbus, Ohio, United States, 43212
Actively Recruiting
Research Team
M
Matthew Cooney, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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