Neoadjuvant Concomitant Modulated Electro-hyperthermia in HER2-negative Breast Cancer

PHASE2/PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

71

Participants

Timeline

Start Date

February 20, 2023

Primary Completion Date

May 31, 2025

Study Completion Date

August 31, 2025

Conditions
HER2-negative Breast Cancer
Interventions
DEVICE

Oncotherm EHY-2030

Oncotherm EHY-2030 is a non-invasive electromagnetic devices with known anti-tumoral effects. It operates in a precision capacitive coupled impedance matched way, working on a radiofrequency of 13.56 MHz. mEHT exploits various biophysical differences of cancer cells. For example, energy absorption on the membrane rafts is different than those of healthy host cells, and damage-associated molecular patterns (DAMPS) will also occur leading to programmed or immunogenic tumor cell death. mEHT can enhance DNA fragmentation of tumor cells, increase the fraction of cells with low mitochondrial membrane potential, increase the concentration of intracellular Ca2+, increase the Fas, c-Jun N-terminal kinases and MAPK/ERK signaling pathways, increase the expression of pro-apoptotic Bcl-2 family proteins and can up-regulate the expression of genes associated with the molecular function of cell death (EGR1, JUN, and CDKN1A) and silencing others associated with cytoprotective functions.

DRUG

Paclitaxel

weekly paclitaxel for 12 weeks

DRUG

Carboplatin

added to weekly paclitaxel if patient has triple-negative breast cancer

DRUG

Cyclophosphamide/Doxorubicin

according to the AC protocol

PROCEDURE

Breast cancer removal surgery

Either breast-conserving surgery or total mastectomy after the neoadjuvant chemotherapy with or without mEHT (if feasible)

Trial Locations (1)

1083

Division of Oncology, Department of Internal Medicine and Oncology, Semmelweis University, Budapest

All Listed Sponsors
lead

Semmelweis University

OTHER