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

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.