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

Study acronym: DELUMA
StatusRecruiting
PhasePhase 2
Started

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Record History

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  1. Trial sites expanded: 5 → 8 locations
    • Interventions: Melphalan/HDS followed by Physician's choice of SOC (eribulin, vinorelbine, or capecitabine) (Drug), Physician's choice of SOC (eribulin… to Melphalan/HDS followed by Physician's choice of SOC (eribulin, vinorelbine, or capecitabine) (Drug), Physician's choice of SOC (eribulin…
    • Eligibility criteria expanded, about 38 words
    • Secondary endpoints: details revised at 1 of 8 entries
  2. Trial sites expanded: 2 → 5 locationsv5
  3. Study sites: 1 to 2v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2025 to Jan 29, 2026
    • Study sites: 0 to 1
    v3
  5. Eligibility criteria shortened, about 194 wordsv2
  6. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06875128
Lead Sponsor Delcath Systems Inc.
Conditions
(from sponsor)		 Metastatic Breast Cancer in the Liver
Related terms Breast Neoplasms
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov