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

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

March 31, 2017

Primary Completion Date

December 31, 2019

Study Completion Date

February 29, 2020

Conditions
Breast Cancer
Interventions
DRUG

ThermoDox (Thermally Sensitive Liposomal Doxorubicin)

A dose of 40 mg/m2 will be administered at each cycle for a total of 6 cycles. ThermoDox will be administered in conjunction with hyperthermia.

RADIATION

Radiation Therapy

A total of 40 Gy in 20 fractions of 2 Gy per fraction will be administered. Up to 66 Gy of radiation therapy can be administered however institutional guidelines should be followed.

DEVICE

Superficial Hyperthermia

Thermal dose is an one-hour treatment at a temperature between 40 and 43 degrees Celsius at the target site.

Trial Locations (3)

Unknown

Inst. of Radiation Oncology Hospital Na Bulovce, Prague

Rambam Health Care Campus, Haifa

Fondazione Del Piemonte Per L'Oncologia - Irccs Candiolo, Candiolo

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Imunon

INDUSTRY

NCT02850419 - Heat-Activated Target Therapy of Local-Regional Relapse in Breast Cancer Patients | Biotech Hunter | Biotech Hunter