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
← catalyst calendarNCT06875128 · readout ≤ 1,015 d
Sponsored by Delcath Systems Inc. (industry) · DCTH — their whole pipeline →.
Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
90estimated
Sites
5
Countries
Italy, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-01-29 | actual | When the study began enrolling |
| Primary completion | May 2029 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Aug 2029 | estimated | The whole study's end, after follow-up |
| First posted | 2025-03-13 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-01 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Metastatic Breast Cancer in the Liver
Interventions
- Drug: Melphalan/HDS followed by Physician's choice of SOC (eribulin, vinorelbine, or capecitabine)
- Drug: Physician's choice of SOC (eribulin, vinorelbine, or capecitabine)
Primary outcome
what the primary-completion date above is the date OFhPFS
measured assessed through study completion, an average of 2 years
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