NCT05889390

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

[A Prospective, Randomized Trial to Assess the Added Value of Concomitant Modulated Electro-hyperthermia in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy - an Investigator Initiated Study]

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Semmelweis University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a pivotal, randomized (1:1), open-label, two-treatment group, single-centre trial of Oncotherm EHY-2030, a modulated electro-hyperthermia (mEHT) device. Female patients aged 18 years or older with locally advanced, unilaterally localized HER2-negative breast cancer requiring neoadjuvant treatment are eligible for the study. In the study, the wTAX (+ carboplatin) +AC neoadjuvant chemotherapy protocol will be administered according to the routine daily regimen, with or without mEHT three times a week during the wTAX (+ carboplatin) period. Carboplatin will be administered for patients with triple-negative breast cancer only. Primary objective: to compare whether the percentage of tumor size decrease determined by imaging techniques is different in the two treatment groups? Secondary and other objectives: * Is complete pathological response (pCR) more common in the mEHT-treated group? * Does the pattern of treatment response (pCR : pPR : pNR) differ between the two groups? * Is the quality of life of patients different in the two study groups? * Is there any treatment-related changes in the routine laboratory parameters such as blood count, liver enzymes, renal function? And do these differ in the two study arms? * Safety and tolerability analysis of the device.

Conditions

• HER2-negative Breast Cancer

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2023-02-20
• Primary completion: 2025-05-31
• Completion: 2025-08-31
• First posted: 2023-06-05
• Last updated: 2024-12-03

Locations

1 site across 1 country: Hungary