Overview

Immunopheresis Alone or In Combination With Chemotherapy Versus Chemotherapy Alone in Advanced Triple Negative Breast Cancer (TNBC)

Status:
Recruiting

Trial end date:
2022-07-31

Target enrollment:

Participant gender:

Summary

This is a multicenter, open-label, Phase 1/ 2 study to evaluate the short-term and longer-term safety, tolerability, and effectiveness of immunopheresis with the LW-02 device in removal of Soluble Tumor Necrosis Factor Receptors (sTNF-Rs) from plasma of patients with advanced, refractory Triple Negative Breast Cancer (TNBC) and for disease control when employed as monotherapy, or in combination with a low dose weekly taxane (paclitaxel) plus carboplatin chemotherapy regimen. A weekly, combination of low dose paclitaxel plus carboplatin (paclitaxel+carboplatin) chemotherapy regimen will serve as control.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

Immunicom Inc

Treatments:

Albumin-Bound Paclitaxel
Antineoplastic Agents
Carboplatin
Paclitaxel