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
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.
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.
Parallel
Melphalan/HDS followed by Physician's choice of SOC (eribulin, vinorelbine, or capecitabine)
DrugMelphalan/HDS followed by Physician's choice of SOC (eribulin, vinorelbine, or capecitabine)
Physician's choice of SOC (eribulin, vinorelbine, or capecitabine)
DrugPhysician's choice of SOC (eribulin, vinorelbine, or capecitabine)
hPFS
Hepatic Progression Free Survival
PFS
Progression Free Survival
ORR
Overall Response Rate complete response \[CR\] + partial response \[PR\]
hORR
Hepatic Overall Response Rate
DOR
Duration of Response
Safety and Tolerability
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Pharmacokinetic Endpoint
Local and systemic exposure of melphalan administered by the HDS
Click on the lead sponsor to view all of their trials.
