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
DELUMA
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
Other study identifiers
Sponsor study identifier
interventional
90
7 countries
13
Study Start
January 29, 2026
Actual (reported)Primary Completion
May 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Brief 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
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- recruiting
- Estimated enrollment
- 90 participants
- Study completion date
August 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
- Listed locations
- 7 countries · 13 sites
Trial Relationships
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
March 6, 2025
Actual (reported)First Posted
March 13, 2025
Actual (reported)Study Start
January 29, 2026
Actual (reported)Primary Completion
May 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
- Last Updated
- October 19, 2026
- Status Verified
- October 2026
- Last Update Submitted
- October 15, 2026