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

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 therap

Trial Details

NCT ID
NCT06875128
Phase
PHASE2
Sponsor
Delcath Systems Inc.
Status
RECRUITING
Cancer Type
ER/PR Positive (Hormone Receptor Positive) Breast Cancer
Interventions
  • Melphalan/HDS followed by Physician's choice of SOC (eribulin, vinorelbine, or capecitabine)
  • Physician's choice of SOC (eribulin, vinorelbine, or capecitabine)
Locations (sample)
  • Tampa, Florida, United States|27.94752,-82.45843
  • Cleveland, Ohio, United States|41.4995,-81.69541
  • Columbus, Ohio, United States|39.96118,-82.99879
  • Dallas, Texas, United States|32.78306,-96.80667
  • Milan, Italy|42.78235,12.59836

Key Eligibility Criteria

  • Histologically confirmed diagnosis of MBC.
  • Patients with HER2-negative (IHC 0 or 1+ or 2+ and ISH non-amplified) MBC (including triple negative disease).
  • Patient with Hormone Receptor-Positive disease has progressed on or intolerant of prior endocrine therapy and CDK 4/6 inhibitors.
  • Disease progression after TOPO-1 isomerase inhibitor payload ADC, such as sacituzumab govitecan and/or trastuzumab deruxtecan. Patients not eligibl…

For full eligibility, visit ClinicalTrials.gov.

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