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Study of melphalan followed by eribulin, vinorelbine, or capecitabine versus eribulin, vinorelbine, or capecitabine alone for metastatic breast cancer patients with liver disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at metastatic breast cancer with liver dominant disease. Metastatic breast cancer means that the cancer has spread from the breast to other parts of the body. Liver dominant disease means that most of the cancer is located in the liver, or the most serious part of the disease is in the liver. The study is specifically for people with HER2-negative breast cancer, which is a specific type of breast cancer based on certain markers found on the cancer cells. The study will use several different medications: melphalan given through a special delivery system called HDS, eribulin, vinorelbine, and capecitabine. Melphalan is given directly into the blood vessels that supply the liver through a procedure that involves placing a thin tube into blood vessels in the groin area. Eribulin and vinorelbine are given through a vein, while capecitabine is taken by mouth as tablets.

The purpose of the study is to find out if giving melphalan through the special liver delivery system followed by treatment with one of the other medications works better than giving one of those other medications alone in controlling the cancer in the liver. The study will compare how long patients go without their liver cancer getting worse when they receive the combination treatment versus when they receive only one of the single medications. The study will also look at other measures such as how long patients live, how many patients see their tumors shrink, and how long the response to treatment lasts.

Patients in this study will be randomly assigned to one of two treatment groups. One group will first receive melphalan treatment directed to the liver, followed by treatment with either eribulin, vinorelbine, or capecitabine chosen by their doctor. The other group will receive only one of these three medications without the melphalan treatment first. Patients will be monitored with scans such as computed tomography and magnetic resonance imaging to check how the cancer is responding to treatment. The study will follow patients for up to two years of treatment and will continue to track their health outcomes over time.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Assignment to treatment group

    Upon joining the study, you will be randomly assigned to one of two treatment groups.

    The first group will receive an induction treatment (initial treatment phase) with melphalan delivered through a specialized procedure, followed by consolidation treatment (follow-up treatment phase) with one of three chemotherapy medications chosen by your doctor.

    The second group will receive only one of the three chemotherapy medications without the initial melphalan treatment.

  2. Step 2

    Induction treatment phase (if assigned to first group)

    If you are assigned to the first treatment group, you will receive melphalan through a procedure called HDS (hepatic delivery system).

    This procedure involves delivering the medication directly to the liver through blood vessels using a catheter (a thin tube inserted into your artery and vein).

    The medication melphalan is administered as a powder mixed with liquid to create a solution for injection or infusion directly into the liver's blood supply.

    This treatment targets the cancer in your liver specifically.

  3. Step 3

    Selection of chemotherapy medication

    Your doctor will choose one of three chemotherapy medications for your treatment: eribulin, vinorelbine, or capecitabine.

    This choice will be based on your individual medical situation and what your doctor considers most suitable for you.

    If you are in the first group, this medication will be given after the melphalan treatment as consolidation therapy.

    If you are in the second group, this will be your only treatment medication throughout the study.

  4. Step 4

    Treatment with eribulin (if selected by your doctor)

    If eribulin is selected, you will receive this medication as an infusion into your vein (intravenous infusion).

    The medication is provided as a solution for injection with a concentration of 0.44 mg per ml.

    Your doctor will determine the specific dosage, frequency of administration, and duration of treatment based on your condition and response to therapy.

  5. Step 5

    Treatment with vinorelbine (if selected by your doctor)

    If vinorelbine tartrate is selected, you will receive this medication through intravenous infusion (into your vein) or intravenous administration.

    The medication is provided as a concentrate for solution for infusion with a concentration of 10 mg per ml.

    Your doctor will determine the specific dosage, frequency of administration, and duration of treatment based on your condition and response to therapy.

  6. Step 6

    Treatment with capecitabine (if selected by your doctor)

    If capecitabine is selected, you will take this medication by mouth (oral administration) in the form of film-coated tablets.

    The tablets are available in two strengths: 150 mg and 500 mg.

    Your doctor will determine the specific dosage, frequency of administration, and duration of treatment based on your condition and response to therapy.

    You will need to follow the instructions provided regarding when and how to take the tablets.

  7. Step 7

    Regular monitoring and scans

    Throughout the study, you will undergo regular monitoring to assess how the treatment is working and to check for any side effects.

    This will include imaging scans such as CT scans (computed tomography) and MRI scans (magnetic resonance imaging) to evaluate the cancer in your liver and other areas.

    Your doctor will also perform blood tests to monitor your liver function, blood cell counts, and other important health indicators.

    These assessments will help determine whether the cancer is responding to treatment, remaining stable, or progressing.

  8. Step 8

    Continuation of treatment

    You will continue receiving your assigned treatment for as long as it is effective and you are tolerating it without unacceptable side effects.

    The study will monitor several outcomes, including hepatic progression free survival (time without cancer progression in the liver), overall progression free survival (time without cancer progression anywhere in the body), and overall survival.

    Your doctor will regularly evaluate your response to treatment and make adjustments as needed based on your individual situation.

Who can join the trial?

22 criteria

  • You must be 18 years of age or older at the time you agree to join the study
  • You must have metastatic breast cancer, which means breast cancer that has spread to other parts of the body, with the main problem being in the liver
  • The cancer in your liver must be able to be measured using CT scan (a special type of X-ray) or MRI (a scan using magnets to create pictures of the inside of your body)
  • If you have cancer spread outside the liver, it must be limited in size and location, and the most serious disease must be in the liver. Cancer outside the liver can only be in the breast, lung, other internal organs, lymph nodes (small bean-shaped organs that are part of your immune system), bones, and skin
  • Each area of cancer outside the liver must be no larger than 3 centimeters across, and all areas of cancer outside the liver together must not be larger than 20 centimeters in total. Within each organ, the cancer cannot be larger than 5 centimeters. Cancer in the bones is allowed but does not count toward this size limit
  • You must weigh at least 35 kilograms (about 77 pounds)
  • Scans of your chest, abdomen (belly area), pelvis (hip area), and liver must be done within 28 days before you are assigned to a treatment group
  • You must have an ECOG performance status of 0 to 1, which means you are able to care for yourself and carry out light activities or work
  • Your liver function tests must show that your liver is working well enough, checked within 14 days before you are assigned to a treatment group. This includes tests for bilirubin (a substance made when your body breaks down old red blood cells), prothrombin time (how long it takes your blood to clot), and liver enzymes (proteins that help your liver work)
  • Your blood counts must be adequate, checked within 14 days before you are assigned to a treatment group. This includes having enough platelets (cells that help blood clot), hemoglobin (protein in red blood cells that carries oxygen), white blood cells (cells that fight infection), and neutrophils (a type of white blood cell)
  • Your kidney function must be adequate, with a creatinine clearance (a measure of how well your kidneys filter waste) greater than 50, checked within 14 days before you are assigned to a treatment group
  • If you are a woman who can become pregnant, you must have a negative pregnancy test within 7 days before you are assigned to a treatment group
  • If you are a woman who can become pregnant or a man who can father a child, you or your partner must use highly effective birth control from the time you agree to join the study until at least 6 months after your last study treatment
  • Your breast cancer diagnosis must be confirmed by examining tissue under a microscope
  • You must sign a document showing you understand the study and agree to participate
  • Your breast cancer must be HER2-negative, which means it does not have high levels of a protein called HER2
  • If your cancer is hormone receptor-positive (grows in response to hormones), it must have gotten worse despite treatment with endocrine therapy (hormone-blocking medicines) and CDK 4/6 inhibitors (medicines that slow cancer cell growth), or you were unable to tolerate these treatments
  • Your cancer must have gotten worse after treatment with certain newer cancer medicines called antibody-drug conjugates, or you must not be eligible or suitable for these medicines. If these medicines are not available where you live, you must have received at least two standard chemotherapy treatments for your type of breast cancer
  • Your doctor must believe that treatment with a single chemotherapy medicine is appropriate for you
  • Your doctor must believe that you are a suitable candidate for treatment with one of the following medicines: eribulin, vinorelbine, or capecitabine
  • The majority of your cancer must be in the liver, or the most life-threatening part of your cancer must be in the liver
  • The cancer in your liver must involve no more than half of your liver tissue

Who cannot join the trial?

3 criteria

  • The study does not list specific exclusion criteria in the provided information, which means the detailed reasons why patients cannot participate are not available in this document.
  • Generally, clinical trials have exclusion criteria to ensure patient safety and study accuracy, but these specific details would need to be obtained from the complete study protocol.
  • Patients interested in this trial should discuss their individual medical situation with their treating doctor to determine if they might be eligible or if there are reasons they should not participate.
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Investigated drugs

  • Melphalan/HDS

    is a cancer treatment that combines melphalan, a chemotherapy medicine that works by stopping cancer cells from growing and dividing, with a special drug delivery system called HDS that helps deliver the medication directly to the liver through its blood vessels.

  • Eribulin

    is a chemotherapy medicine that works by preventing cancer cells from dividing and growing. It is used to treat breast cancer that has spread to other parts of the body.

  • Vinorelbine

    is a chemotherapy medicine that stops cancer cells from dividing and multiplying. It is commonly used to treat various types of cancer, including breast cancer that has spread.

  • Capecitabine

    is a chemotherapy medicine taken by mouth that the body converts into a substance that kills cancer cells. It is used to treat breast cancer that has spread to other parts of the body.

What is already known about the treatment

  • Melphalan/HDS

    Melphalan combined with a Hepatic Delivery System (HDS) is an experimental cancer treatment currently being studied in clinical trials for patients with breast cancer that has spread primarily to the liver. This medication works by delivering the chemotherapy drug melphalan directly to the liver through a special delivery system, where it damages the DNA of cancer cells and prevents them from multiplying and growing. The treatment is being tested as an induction therapy, meaning it is given first to reduce the tumor burden before continuing with other standard chemotherapy medications. Melphalan belongs to a class of drugs called alkylating agents, which are commonly used to treat various types of cancer.

  • Eribulin

    Eribulin is an approved chemotherapy medication given through injection into a vein to treat certain types of breast cancer that have spread to other parts of the body. This drug works by interfering with the cell's internal skeleton called microtubules, which are necessary for cancer cells to divide and multiply, ultimately causing the cancer cells to stop growing and die. It is typically used in patients whose cancer has progressed after receiving other chemotherapy treatments. Eribulin belongs to a class of medications known as microtubule inhibitors and is one of the standard treatment options for advanced breast cancer.

  • Vinorelbine

    Vinorelbine is a chemotherapy medication that can be given either through injection into a vein or taken as a capsule by mouth, used to treat various types of cancer including breast cancer that has spread to other organs. This medication works by blocking the formation of microtubules, which are structures inside cells that help them divide, thereby preventing cancer cells from multiplying and causing them to die. It is commonly used as a treatment option for patients with advanced or metastatic breast cancer who need chemotherapy. Vinorelbine is classified as a vinca alkaloid, a type of plant-derived chemotherapy drug.

  • Capecitabine

    Capecitabine is an oral chemotherapy medication taken as a tablet that is used to treat several types of cancer, including breast cancer that has spread to other parts of the body. Once swallowed, this medication is converted by the body into an active form called 5-fluorouracil, which interferes with the cancer cells' ability to make DNA and RNA, essential materials needed for cells to grow and multiply. It is often preferred by some patients because it can be taken at home rather than requiring hospital visits for intravenous chemotherapy. Capecitabine belongs to a class of drugs called antimetabolites, which mimic natural substances in the body but disrupt normal cell processes in cancer cells.

Investigated diseases

Refractory Metastatic Breast Cancer with Liver Dominant Disease – This is an advanced form of breast cancer that has spread from the breast to other parts of the body, with the liver being the main site affected by the cancer. The term refractory means that the cancer has not responded well to previous treatments or has continued to grow despite therapy. In this condition, cancer cells from the breast travel through the bloodstream or lymphatic system and establish new tumors primarily in the liver. The liver becomes the dominant site where the cancer is growing and causing the most concern. As the disease progresses, the liver metastases can grow larger and may affect liver function. This condition represents a challenging stage of breast cancer where the disease has become widespread and difficult to control.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521966-91-00Protocol codePHP-MBC-202Estimated enrolment102 patientsSponsorDelcath Systems Inc.

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