OncoMatch/Clinical Trials/NCT06875128
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
Is NCT06875128 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Melphalan/HDS followed by Physician's choice of SOC (eribulin, vinorelbine, or capecitabine) and Physician's choice of SOC (eribulin, vinorelbine, or capecitabine) for metastatic breast cancer in the liver.
Treatment: Melphalan/HDS followed by Physician's choice of SOC (eribulin, vinorelbine, or capecitabine) · Physician's choice of SOC (eribulin, vinorelbine, or capecitabine) — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative (ihc 0 or 1+ or 2+ and ish non-amplified)
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: endocrine therapy — Hormone Receptor-Positive disease
Patient with Hormone Receptor-Positive disease has progressed on or intolerant of prior endocrine therapy
Must have received: CDK4/6 inhibitor — Hormone Receptor-Positive disease
Patient with Hormone Receptor-Positive disease has progressed on or intolerant of prior...CDK 4/6 inhibitors.
Must have received: topoisomerase I inhibitor antibody-drug conjugate (sacituzumab govitecan, trastuzumab deruxtecan)
Disease progression after TOPO-1 isomerase inhibitor payload ADC, such as sacituzumab govitecan and/or trastuzumab deruxtecan.
Must have received: chemotherapy
patients will be eligible after prior treatment or intolerable toxicity on two standard chemotherapy regimens for the appropriate disease subtype
Cannot have received: chemoembolization
Prior chemoembolization or radioembolization to the liver
Cannot have received: radioembolization
Prior chemoembolization or radioembolization to the liver
Cannot have received: hepatic arterial infusion therapy
prior hepatic arterial infusion therapy
Cannot have received: radiotherapy
Received anti-cancer therapy including radiotherapy or investigational agent for any indication ≤ 30 days prior to randomization
Cannot have received: investigational agent
Received anti-cancer therapy including radiotherapy or investigational agent for any indication ≤ 30 days prior to randomization
Lab requirements
Liver function
MBC metastases must involve ≤ 50% of the liver parenchyma; no clinically significant portal hypertension; albumin level ≥ 3.0 g/dL
Cardiac function
No NYHA class II, III, or IV or active cardiac condition(s), including unstable coronary syndromes, worsening or new-onset congestive heart failure, significant arrhythmias, or severe valvular disease
Evidence of clinically significant portal hypertension by history, endoscopy, or radiologic studies (large abdominal varices, prior history of varices by endoscopy). Albumin level < 3.0 g/dL. 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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Moffitt Cancer Center · Tampa, Florida
- Ohio State University, Stefanie Spielman Comprehensive Breast Center · Columbus, Ohio
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