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

2025-521966-91-00 · tracked via the Priya Life Science EU tracker

Sponsor

Delcath Systems Inc.

Sponsor type

Pharmaceutical company

Therapeutic area

Neoplasms

Decision date

04/02/2026

Enrollment target

Sites

Italy, Spain, Sweden, France, Germany

Condition studied

Refractory Metastatic Breast Cancer with Liver Dominant Disease

Investigational medicinal product(s)

Xeloda 500 mg film-coated tabletsXeloda 150 mg film-coated tabletsVinorelbina Aurobindo 10 mg/ml concentrato per soluzione per infusione.HALAVEN 0.44 mg/ml solution for injectionVinorelbina Aurobindo 10 mg/ml concentrato per soluzione per infusione.MELPHALAN HIKMA 50 mg/10mlpoudre et solvant pour solution injectable / pour perfusion

Eligibility

Age group

65+ years, 18-64 years

Sex

Female, Male

Primary endpoint

Hepatic progression free survival (hPFS)

Endpoint detail

Progression free survival (PFS), Overall response rate (ORR) (complete response [CR] + partial response [PR]), Hepatic ORR (hORR), Duration of response (DOR), Hepatic DOR (hDOR), Disease control rate (DCR), Hepatic DCR (hDCR), Overall survival (OS)

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-521966-91-00 on CTIS ↗ ← All trials in the EU