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

Conditions

• Metastatic Breast Cancer in the Liver

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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 Details

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

Key Dates

Start date

Jan 29, 2026

Status verified

May 2026

Primary completion

May 31, 2029

Completion

Aug 31, 2029

Study Design

Enrollment

90 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 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.
• Active Comparator: Physician's choice of SOC (eribulin, vinorelbine, or capecitabine) Alone
  Physician's choice of SOC (eribulin, vinorelbine, or capecitabine)

Primary Outcome Measure

hPFS [ Time Frame: assessed through study completion, an average of 2 years ]

Central Contacts

• Matthew Cooney, MD
  216-374-8221
  [email protected]

Locations (4)

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