A prospective randomized trial at Semmelweis University is investigating whether concomitant modulated electro-hyperthermia (mEHT) enhances pathologic response when added to standard neoadjuvant chemotherapy in stage II–III HER2-negative breast cancer. The trial is currently active but no longer enrolling participants.
A Phase 2/3 investigator-initiated randomized trial (NCT05889390) is examining the potential benefit of integrating modulated electro-hyperthermia (mEHT) — delivered via the Oncotherm EHY-2030 device — into neoadjuvant chemotherapy regimens for patients with HER2-negative, stage II–III breast cancer. The trial is being conducted at Semmelweis University and is currently active but closed to new enrollment.
Modulated electro-hyperthermia is a capacitive radiofrequency-based technique that selectively elevates tumor tissue temperature to enhance cytotoxic susceptibility, potentially augmenting the antitumor activity of concurrent systemic agents. In this trial, mEHT is administered concomitantly with chemotherapy regimens incorporating paclitaxel, carboplatin, and cyclophosphamide/doxorubicin, followed by definitive breast surgery.
The HER2-negative subgroup — encompassing both hormone receptor-positive/HER2-negative and triple-negative breast cancer — represents a population with variable neoadjuvant chemotherapy response rates, particularly in the triple-negative subset where pathologic complete response remains a key surrogate endpoint for long-term outcomes. The addition of a non-pharmacologic sensitizing modality such as mEHT may offer a strategy to improve tumor downstaging without introducing additional systemic toxicity.
As an investigator-initiated study, the trial's generalizability and statistical power relative to industry-sponsored trials may be limited. Full efficacy and safety data are pending completion of follow-up and analysis.
Key points
- Phase 2/3 randomized trial assessing concomitant modulated electro-hyperthermia (mEHT) added to neoadjuvant chemotherapy in HER2-negative stage II–III breast cancer
- mEHT delivered via Oncotherm EHY-2030 device alongside paclitaxel, carboplatin, and cyclophosphamide/doxorubicin regimens
- Trial is active but no longer recruiting; conducted at Semmelweis University as an investigator-initiated study
- Primary aim is to determine whether mEHT improves tumor response in the neoadjuvant setting prior to definitive breast surgery
- Targets a clinically heterogeneous population including hormone receptor-positive/HER2-negative and triple-negative breast cancer subtypes
Why it matters
Pathologic complete response rates in HER2-negative breast cancer — particularly in non-triple-negative subtypes — remain suboptimal with standard neoadjuvant chemotherapy; mEHT represents a novel, non-systemic sensitization strategy that, if effective, could improve surgical downstaging outcomes without compounding chemotherapy-related toxicity.