Heat-Activated Target Therapy of Local-Regional Relapse in Breast Cancer Patients — EURO-DIGNITY  

Breast Cancer Clinical Trial

Official title: Heat-Activated Target Therapy (Radiotherapy + Hyperthermia + Lyso-Thermosensitive Liposomal Doxorubicin) of Local-Regional Relapse in Breast Cancer Patients

Status Withdrawn

Clinical Trial Summary

The 105-15-201 study is designed to assess the effectiveness and tolerability of the combination of heat-activated target therapy (radiotherapy + hyperthermia + lyso-thermosensitive liposomal doxorubicin) of loco-regional relapse in breast cancer patients.

Clinical Trial Description

Locoregional recurrence of breast cancer (LRR) after mastectomy is a clinically challenging problem. Between 5% and 35% of women with operable breast cancer will experience an isolated LRR following their primary treatment, usually within 5 years of initial mastectomy. LRR or LR typically causes pain, lymphedema, and/or loss of freedom of movement. Therapeutic options usually involve resection, radiation or, at some specialized centers, combined radiation and hyperthermia. However, local control remains suboptimal in previously irradiated chest wall patients with the combination of radiation and hyperthermia providing local control rates of about 65%.

Lyso-thermosensitive liposomal doxorubicin (LTLD) is a temperature sensitive liposome which is systemically administered and is engineered to selectively release its doxorubicin contents when exposed to temperatures ≥ 39.5°C.

Local mild hyperthermia (40 to 44°C) is cytotoxic and is known to have an immunomodulatory effect along with a radiation and chemosensitizing effect in the heated tissue. Furthermore, mild hyperthermia enhances leakiness of tumor tissue, increases local perfusion and upregulates transvascular transport of doxorubicin.

Radiation therapy will be administered in this combination therapy.

This study evaluates the application of a tri-modal approach with LTLD to improve outcome:

radiation, hyperthermia, and targeted release of a novel formulation of doxorubicin. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT02850419
• Study type: Interventional
• Source: Celsion
• Status: Withdrawn
• Phase: Phase 2
• Start date: March 2017
• Completion date: February 2020