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

NCT05889390 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2026-05-15

No results posted yet for this study

Summary

The aim of this study is to investigate whether the application of concomitant modulated electro-hyperthermia in a neoadjuvant chemotherapeutic setting is beneficial for patients with HER2-negative, stage II-III breast cancer.

Conditions

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)

Sponsors & Collaborators

  • Semmelweis University

    lead OTHER

Principal Investigators

  • Magdolna Dank, M.D./Ph.D. · Semmelweis University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-20
Primary Completion
2025-10-31
Completion
2026-12-31

Countries

  • Hungary

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05889390 on ClinicalTrials.gov