Study on High Dose Melphalan Treatment Directly to the Liver for Metastatic Breast Cancer with Liver-Dominant Disease

Sponsor: Delcath Systems Inc.

Sponsor score: 0

ClinicalTrials ID:NCT06875128

Provider View

This clinical trial is testing whether a high dose of chemotherapy given directly to the liver, followed by standard cancer treatment, is safe and effective for patients with breast cancer that has spread mainly to the liver. The study will compare this approach to using standard cancer treatment alone.

Patient Parameters

Program Overview

The aim of this study is to find out if delivering a high dose of chemotherapy directly to the liver, followed by approved cancer treatments, is safe and can effectively treat breast cancer that has spread to the liver. Researchers will compare the outcomes of patients receiving this liver-directed therapy plus standard treatment to those receiving only the standard treatment. Participants will undergo up to two cycles of liver-directed chemotherapy followed by standard treatment or receive standard treatment alone. They will visit the clinic every two weeks for checkups and tests, and have scans approximately every 8 weeks to monitor their progress.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with metastatic breast cancer (MBC).
  • Have HER2-negative breast cancer, including triple-negative disease.
  • If hormone receptor-positive, must have tried and not responded to prior hormone therapy and CDK 4/6 inhibitors.
  • Disease must have progressed after certain treatments like sacituzumab govitecan or trastuzumab deruxtecan, or not be suitable for these treatments.
  • Suitable for single-agent chemotherapy as determined by the doctor.
  • Candidate for treatment with eribulin, vinorelbine, or capecitabine.
  • Cancer is mainly in the liver, with the majority of tumors or life-threatening disease located there.
  • Liver metastases involve 50% or less of the liver.
  • Any cancer outside the liver is limited and not life-threatening.
  • Liver disease must be measurable by CT or MRI scans.
  • Weigh at least 35 kg.
  • Scans to determine eligibility must be done within 28 days before starting the study.
  • Have an ECOG performance status of 0-1, meaning fully active or restricted in physically strenuous activity but ambulatory.

Exclusion Criteria

  • Previous liver-directed treatments like chemoembolization or radioembolization.
  • Significant liver-related health issues like portal hypertension.
  • Serious heart conditions or recent heart problems.
  • Severe lung disease that prevents general anesthesia.
  • Bleeding disorders or brain metastases that increase bleeding risk.
  • Active second cancer or recent invasive cancer treatment within 2 years, except for certain skin or thyroid cancers.
  • Symptoms indicating significant disease progression.
  • Pregnant or breastfeeding women.
  • Women of childbearing potential who cannot avoid menstruation during treatment.
  • Need for chronic immunosuppressive drugs, except low-dose steroids.
  • Cannot stop blood thinners temporarily.
  • Active bacterial infections or certain viral infections like Hepatitis B or C.
  • Severe allergic reactions to iodine contrast or melphalan.
  • Latex allergy or heparin sensitivity.
  • Uncontrolled endocrine disorders like diabetes.
  • Recent cancer treatment within 30 days before starting the study.
  • Not fully recovered from previous treatment side effects.
  • Recent surgery with unhealed wounds.
  • Currently being treated for another cancer or not cancer-free.
  • Not eligible for eribulin, vinorelbine, or capecitabine.
  • Low albumin levels below 3.0 g/dL.

Locations

FACILITYZIPCITYSTATE
Moffitt Cancer Center33612TampaFlorida
Ohio State University, Stefanie Spielman Comprehensive Breast Center43212ColumbusOhio

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