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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-521966-91-00

Enrollment

Registered

2026-02-04

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory Metastatic Breast Cancer with Liver Dominant Disease

Brief summary

Hepatic progression free survival (hPFS)

Detailed description

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)

Interventions

DRUGVinorelbina Aurobindo 10 mg/ml concentrato per soluzione per infusione.

DRUGHALAVEN 0.44 mg/ml solution for injection

DRUGXeloda 500 mg film-coated tablets

DRUGMELPHALAN HIKMA 50 mg/10ml

DRUGpoudre et solvant pour solution injectable / pour perfusion

DRUGXeloda 150 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Hepatic progression free survival (hPFS)	—

Secondary

Measure	Time frame
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)	—

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 5, 2026