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NCT06875128 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Metastatic Breast Cancer in the Liver, sponsored by Delcath Systems.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
- 2
- Study locations
NCT06875128: Recruiting Phase 2 study of Metastatic Breast Cancer in the Liver, sponsored by Delcath Systems.
NCT06875128 is a Phase 2 study of Metastatic Breast Cancer in the Liver that is actively recruiting participants, run by Delcath Systems. The registered enrollment target is 90 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06875128, a Phase 2 study of Metastatic Breast Cancer in the Liver, is actively recruiting participants, sponsored by Delcath Systems.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
- 2
- Study locations
Study 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
Primary Outcome
Hepatic Progression Free Survival
Conditions Studied
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)
Study Locations (2)
Florida
- Moffitt Cancer Center - Tampa
Ohio
- Ohio State University, Stefanie Spielman Comprehensive Breast Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2026-01-29 |
| Est. Completion | 2029-08 |
| Phase | Phase 2 |
What NCT06875128 shows while recruiting
NCT06875128 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower).
The record links to 1 condition, with Metastatic Breast Cancer in the Liver appearing as the primary indexed condition, and to 2 interventions - of which Melphalan/HDS followed by Physician's choice of SOC (eribulin, vinorelbine, or capecitabine) is the first listed.
NCT06875128 reports a single indexed study location in Florida, Ohio.
Frequently Asked Questions
What is clinical trial NCT06875128 about?
NCT06875128 is a clinical study titled "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 wi...
What is the current status of trial NCT06875128?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2026-01-29. Estimated completion is 2029-08.
What conditions does trial NCT06875128 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer in the Liver.
What interventions are being tested in trial NCT06875128?
The interventions under investigation include: Melphalan/HDS followed by Physician's choice of SOC (eribulin, vinorelbine, or capecitabine) (DRUG), Physician's choice of SOC (eribulin, vinorelbine, or capecitabine) (DRUG).
Who is sponsoring clinical trial NCT06875128?
This trial is sponsored by Delcath Systems, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06875128 being conducted?
This trial has 2 study locations across Florida, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06875128's enrollment target sits among peer trials
90 772nd of 2000 higher than 1,200 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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