Metastatic Breast Cancer in the LiverPhase 2DELUMANCT06875128
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 testing Melphalan/HDS followed by Physician's choice of SOC (eribulin, vinorelbine, or capecitabine) and Physician's choice of SOC (eribulin, vinorelbine, or capecitabine) in people with Metastatic Breast Cancer in the Liver, run by Delcath Systems Inc. at 8 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer in the Liver
- What is being tested?
- Melphalan/HDS followed by Physician's choice of SOC (eribulin, vinorelbine, or capecitabine) and Physician's choice of SOC (eribulin, vinorelbine, or capecitabine)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 29 Jan 2026to Aug 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 eligible or suitable for ADCs can be considered for this study. NOTE: In jurisdictions where those ADCs are not available as standard of care, patients will be eligible after prior treatment or intolerable toxicity on two standard chemotherapy regimens for the appropriate disease subtype.
- Patient with HER2-negative breast cancer suitable for single agent chemotherapy as per judgement of treating investigator.
- Patient is a suitable candidate for treatment with one of the following: eribulin, vinorelbine, or capecitabine as per judgement of treating investigator.
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- Patient has liver dominant metastatic disease. Liver-dominant is defined as the majority of total tumor burden is located in the liver, and/or the life-threatening component of the disease is located in the liver.
- MBC metastases must involve ≤ 50% of the liver parenchyma.
- If there is evidence of extrahepatic metastatic disease, it is limited, and the life-threatening component of disease is in the liver. Extrahepatic disease is restricted to lesions in the breast, lung, other visceral organs, lymph nodes and skin.
- Disease in the liver must be measurable (per RECIST v1.1 guidelines) by computed tomography (CT) and/or magnetic resonance imaging (MRI).
- Patient weighs ≥ 35 kg
- Scans used to determine eligibility (CT scan of the chest/abdomen/pelvis and MRI of the liver) must be performed within 28 days prior to randomization.
- Patient has an ECOG PS of 0-1.
Who cannot join
- Prior chemoembolization or radioembolization to the liver or prior hepatic arterial infusion therapy.
- Evidence of clinically significant portal hypertension by history, endoscopy, or radiologic studies (large abdominal varices, prior history of varices by endoscopy).
- New York Heart Association functional classification II, III or IV or active cardiac condition(s), including unstable coronary syndromes (unstable or severe angina, recent myocardial infarction), worsening or new-onset congestive heart failure, significant arrhythmias, or severe valvular disease that create(s) undue risks of undergoing general anesthesia.
- History or evidence of clinically significant pulmonary disease that precludes the use of general anesthesia.
- History of bleeding disorders, presence of brain metastases or other intracranial abnormalities that would put them at risk for bleeding with anti-coagulation.
- Known varices at risk of bleeding, including medium or large esophageal or gastric varices, active peptic ulcer, or history of recent hemoptysis.
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- An active second malignancy or has a history of recent definitively treated invasive cancer within 2 years prior to enrolment. Exceptions are optimally treated and controlled basal cell carcinoma, other skin cancers, thyroid cancer.
- Symptoms and signs indicating clinically significant progression of disease including cord compression, increasing pain symptoms, increasing oxygen requirements, impending pathological fracture, compressive lymphadenopathy, or symptomatic pleural effusion.
- Pregnant or breastfeeding.
- WOCBP (i.e., fertile meaning not permanently sterilized and having had a menstrual period within the past 12 months) who is unable to undergo hormonal suppression to avoid menstruation during treatment.
- Patient requires chronic use of immunosuppressive drugs. NOTE: Oral prednisolone ≤ 10 mg/day or equivalent is allowed.
- Unable to be temporarily removed from chronic anti-coagulation therapy.
- Active bacterial infections with systemic manifestations (malaise, fever, leucocytosis).
- An active infection, including Hepatitis B and Hepatitis C infection. NOTE: Patients with anti-hepatitis B core antibody (HBc) positive, or hepatitis B surface antigen (HBsAg) but DNA negative are allowed exception(s).
- Known severe allergic reaction to iodine contrast that cannot be controlled by premedication with antihistamines and steroids.
- History of or known hypersensitivity to melphalan or the components of the Melphalan/HDS system.
- Known latex allergy.
- History of known hypersensitivity to heparin or the presence of heparin-induced thrombocytopenia.
- Uncontrolled endocrine disorder including diabetes mellitus, hypothyroidism, or hyperthyroidism.
- Received anti-cancer therapy including radiotherapy or investigational agent for any indication ≤ 30 days prior to randomization.
- Patients should have recovered to Grade 1 or less for AEs related to prior treatment unless deemed clinically not significant, such as lymphopenia, anemia, or grade 2 neuropathy due to prior taxane treatment.
- NOTE: Certain side effects that are unlikely to develop into serious or life-threatening events (e.g., alopecia) are allowed at ≥ Grade 1.
- < 28 days after surgery and surgical wound is not fully healed.
- Currently under treatment for cancer other than MBC or is not deemed to be cancer free.
- Not eligible to receive either eribulin or vinorelbine or capecitabine.
- Albumin level < 3.0 g/dL.
Trial locations and contacts
8 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 4 countries
United States5 sites, 5 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44106
- Recruiting
Ohio State University, Stefanie Spielman Comprehensive Breast Center
Columbus, Ohio, 43212
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75325
- Recruiting
University of California Los Angeles
Santa Monica, California, 90404
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospital Southampton
Southampton
About this study
Official title: 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
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
- Conditions
- Metastatic Breast Cancer in the Liver
- Being tested
- Melphalan/HDS followed by Physician's choice of SOC (eribulin, vinorelbine, or capecitabine), Physician's choice of SOC (eribulin, vinorelbine, or capecitabine)
- Keywords
- melphalan, melphalan/HDS, melphalan/hepatic delivery system, eribulin, vinorelbine, capecitabine, metastatic breast cancer, MBC, liver dominant disease, metastatic breast cancer in the liver, hepatic delivery system, PHP, HER2-negative breast cancer, HER-2 negative, Hormone Receptor-Positive disease
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melphalan/HDS followed by Physician's choice of SOC (eribulin, vinorelbine, or capecitabine)Drug
Melphalan/HDS followed by Physician's choice of SOC (eribulin, vinorelbine, or capecitabine)
Physician's choice of SOC (eribulin, vinorelbine, or capecitabine)Drug
Physician's choice of SOC (eribulin, vinorelbine, or capecitabine)
| Study group | Role | What they receive |
|---|---|---|
| Melphalan/HDS followed by Physician's choice of SOC (eribulin, vinorelbine, or capecitabine) | Experimental | Melphalan/HDS is given as an infusion of Melphalan into the hepatic artery under general anesthesia. This treatment is administered then followed by Physician's choice of SOC (eribulin, vinorelbine, or capecitabine) then repeated for a second cycle of Melphanlan/HDS followed by Physician's choice of SOC. Receives: Drug: Melphalan/HDS followed by Physician's choice of SOC (eribulin, vinorelbine, or capecitabine) |
| Physician's choice of SOC (eribulin, vinorelbine, or capecitabine) Alone | Active comparator | Physician's choice of SOC (eribulin, vinorelbine, or capecitabine) Receives: Drug: Physician's choice of SOC (eribulin, vinorelbine, or capecitabine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
hPFS
Hepatic Progression Free Survival
Measured: assessed through study completion, an average of 2 years
Secondary outcomes (8)
PFS
Progression Free Survival
Measured: assessed through study completion, an average of 2 years
ORR
Overall Response Rate complete response [CR] + partial response [PR]
Measured: Baseline through completion of treatment, assessed through study completion, an average of 2 years
hORR
Hepatic Overall Response Rate
Measured: assessed through study completion, an average of 2 years
DOR
Duration of Response
Measured: assessed through study completion, an average of 2 years
hDOR
Hepatic duration of response
Measured: assessed through study completion, an average of 2 years
DCR
Disease control rate
Measured: assessed through study completion, an average of 2 years
hDCR
Hepatic disease control rate
Measured: assessed through study completion, an average of 2 years
OS
Overall Survival
Measured: assessed through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start29 Jan 2026
- Primary completionMay 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast Cancer in the LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Delcath Systems Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06875128
- Sponsor's protocol ID
- PHP-MBC-202
- Acronym
- DELUMA
- Status last verified
- Oct 2026
- First submitted
- 6 Mar 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Delcath does not currently have a plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06875128
- Acronym / sponsor ID
- DELUMA / PHP-MBC-202
- Conditions
- Metastatic Breast Cancer in the Liver
- Keywords
- melphalan, melphalan/HDS, melphalan/hepatic delivery system, eribulin, vinorelbine, capecitabine, metastatic breast cancer, MBC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Delcath Systems Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melphalan/HDS followed by Physician's choice of SOC (eribulin, vinorelbine, or capecitabine) | Experimental | Drug: Melphalan/HDS followed by Physician's choice of SOC (eribulin, vinorelbine, or capecitabine)Melphalan/HDS is given as an infusion of Melphalan into the hepatic artery under general anesthesia. This treatment is administered then followed by Physician's choice of SOC (eribulin, vinorelbine, or capecitabine) then repeated for a second cycle of Melphanlan/HDS followed by Physician's choice of SOC. |
| Physician's choice of SOC (eribulin, vinorelbine, or capecitabine) Alone | Active comparator | Drug: Physician's choice of SOC (eribulin, vinorelbine, or capecitabine)Physician's choice of SOC (eribulin, vinorelbine, or capecitabine) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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 eligible or suitable for ADCs can be considered for this study. NOTE: In jurisdictions where those ADCs are not available as standard of care, patients will be eligible after prior treatment or intolerable toxicity on two standard chemotherapy regimens for the appropriate disease subtype.
- Patient with HER2-negative breast cancer suitable for single agent chemotherapy as per judgement of treating investigator.
Key exclusion criteria (26 listed)
- Prior chemoembolization or radioembolization to the liver or prior hepatic arterial infusion therapy.
- Evidence of clinically significant portal hypertension by history, endoscopy, or radiologic studies (large abdominal varices, prior history of varices by endoscopy).
- New York Heart Association functional classification II, III or IV or active cardiac condition(s), including unstable coronary syndromes (unstable or severe angina, recent myocardial infarction), worsening or new-onset congestive heart failure, significant arrhythmias, or severe valvular disease that create(s) undue risks of undergoing general anesthesia.
- History or evidence of clinically significant pulmonary disease that precludes the use of general anesthesia.
- History of bleeding disorders, presence of brain metastases or other intracranial abnormalities that would put them at risk for bleeding with anti-coagulation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melphalan/HDS followed by Physician's choice of SOC (eribulin, vinorelbine, or capecitabine)Melphalan/HDS followed by Physician's choice of SOC (eribulin, vinorelbine, or capecitabine) | Drug | Melphalan/HDS followed by Physician's choice of SOC (eribulin, vinorelbine, or capecitabine) |
| Physician's choice of SOC (eribulin, vinorelbine, or capecitabine)Physician's choice of SOC (eribulin, vinorelbine, or capecitabine) | Drug | Physician's choice of SOC (eribulin, vinorelbine, or capecitabine) Alone |
Primary outcome
hPFS
Time frame: assessed through study completion, an average of 2 years
Hepatic Progression Free Survival
8 secondary outcomes
PFS
Time frame: assessed through study completion, an average of 2 years
ORR
Time frame: Baseline through completion of treatment, assessed through study completion, an average of 2 years
hORR
Time frame: assessed through study completion, an average of 2 years
DOR
Time frame: assessed through study completion, an average of 2 years
hDOR
Time frame: assessed through study completion, an average of 2 years
DCR
Time frame: assessed through study completion, an average of 2 years
hDCR
Time frame: assessed through study completion, an average of 2 years
OS
Time frame: assessed through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No. Delcath does not currently have a plan to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Melphalan/HDS followed by Physician's choice of SOC (eribulin, vinorelbine, or capecitabine) and Physician's choice of SOC (eribulin, vinorelbine, or capecitabine) in people with Metastatic Breast Cancer in the Liver, run by Delcath Systems Inc. at 8 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Italy, Sweden, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Cooney, MD (216-374-8221, MedicalMonitoring@delcath.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hPFS (time frame: assessed through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.