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HER2-negative Breast CancerPhase 2/3NeoHTerMaNCT05889390

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

A Phase 2/3 study testing Oncotherm EHY-2030, Paclitaxel and Carboplatin in people with HER2-negative Breast Cancer, run by Semmelweis University at 1 site in Hungary.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
HER2-negative Breast Cancer
What is being tested?
Oncotherm EHY-2030, Paclitaxel and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
1 siteHungary
Study dates
20 Feb 2023to 31 Dec 2026
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least 18 years of age
  • Female patient
  • Life expectancy ≥ 6 months
  • De novo histological/cytological diagnosis of HER2-negative (triple-negative or ER/PR+) breast tumor involving one breast
  • Diagnosis of breast tumor ≤ 40 days
  • Locally advanced stage disease (stage II and III) requiring neoadjuvant treatment - according to the following criteria:
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  • Primary breast tumor ≥ 20 mm in size and/or
  • Presence of axillary lymph node metastases
  • Optimal surgical intervention without neoadjuvant chemotherapy is not feasible
  • ECOG status: 0-2
  • Suitable for and designated by the investigator for neoadjuvant therapy with wTAX + (carboplatin) + AC chemotherapeutic agent
  • Willingness to participate in the trial and signed the informed consent form for the protocol

Who cannot join

  • Patient is ≤ 18 years of age.
  • Tumor of both breasts.
  • Diagnosis of breast tumor > 40 days
  • HER2 positive breast tumor
  • Has already received some anticancer therapy
  • Any previous cancer requiring anti-tumor treatment within 5 years prior to selection, except: in situ cervical or uterine cancer and non-melanoma skin cancer.
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  • Co-existing serious diseases:
  • Presence of severe neuropathy requiring medical treatment, diabetic neuropathy.
  • Clinically significant hematological, hepatic or renal dysfunction, as defined below:
  • Neutrophil count < 1.5 G/L and platelet count < 100 G/L
  • bilirubin > 1.5 times the upper limit of normal range (ULN), except for known Gilbert's disease
  • AST and/or ALT > 2.5 times the upper limit of the normal range
  • Serum creatinine > 1.5 times the upper limit of the normal range.
  • Clinically significant cardiovascular disease in the medical history, unless the disease is adequately controlled. E.g. New York Heart Association (NYHA) Class II or worse congestive heart failure (moderate limitation of physical activity; well-being at rest but normal activity is associated with fatigue, rapid heart rate or dyspnoea).
  • Uncontrolled hypertension with resting systolic ≥ 180 mmHg, resting diastolic ≥ 110 mmHg.
  • Resting sinus tachycardia with a pulse ≥ 110/min.
  • History of sympathetic or treatment-naive cardiac arrhythmia. Atrial fibrillation or flutter controlled with medication is not an exclusion for participation in the study.
  • Major cardiovascular event (e.g. myocardial infarction, unstable angina, cerebral vascular accident (CVA), etc.) in the 6 months prior to randomisation.
  • Active infection or severe underlying disease that renders the patient unfit for treatment according to the study protocol.
  • A current diagnosis of chronic hepatitis, Hepatitis B surface antigen positive, Hepatitis C antibody positive and/or other clinically active liver disease requiring treatment.
  • Known HIV infection.
  • Untreated thyroid disease.
  • Systemic autoimmune disease.
  • Any psychiatric condition in the medical history that may result in the patient being unable to understand or comply with the requirements of the study, having reduced communication skills or being unable to give informed consent.
  • Need for concomitant anti-tumor therapy in addition to wTAX + (carboplatin) + AC protocol
  • Any active medical device implanted in the anatomical area, such as pacemakers.
  • Known severe hypersensitivity to any of the chemotherapies used in the study.
  • Pregnancy or breast-feeding (patients of childbearing potential must use effective contraception throughout the study and for 3 months after the end of treatment). The method of effective contraception is at the discretion of the investigator.
  • History of drug or alcohol dependence within 6 months prior to screening.
  • Unable to comply with the study plan for medical, psychological, family, geographical or other reasons.
  • Institutionalisation by administrative or judicial decision.

Trial locations and contacts

1 site in 1 country.

Hungary1 site

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

    Budapest, Budapest, 1083

Other trials in Hungary

About this study

Official title: [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]

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.

Read the 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.
Being tested
Oncotherm EHY-2030, Paclitaxel, Carboplatin, Cyclophosphamide/Doxorubicin, Breast cancer removal surgery
Keywords
hyperthermia, modulated electro-hyperthermia, oncothermia, breast cancer
Medical subject headings
Hyperthermia, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oncotherm EHY-2030Device

    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.

  • PaclitaxelDrug

    weekly paclitaxel for 12 weeks

  • CarboplatinDrug

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

  • Cyclophosphamide/DoxorubicinDrug

    according to the AC protocol

  • Breast cancer removal surgeryProcedure or surgery

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

Study groups in NCT05889390
Study groupRoleWhat they receive
wTAX (+ carboplatin) +ACActive comparator1. wTAX: Weekly paclitaxel (+ carboplatin in the case of triple-negative breast cancer) for 12 weeks 2. AC: Doxorubicin/Cyclophosphamide every three-weeks, 4x 3. Breast cancer tumor removal surgery (if feasible)
Receives: Drug: Paclitaxel; Drug: Carboplatin; Drug: Cyclophosphamide/Doxorubicin; Procedure: Breast cancer removal surgery
wTAX (+ carboplatin) +AC + mEHTExperimental1. wTAX + mWEHT 1. wTAX: Weekly paclitaxel (+ carboplatin in the case of triple-negative breast cancer) for 12 weeks 2. mEHT: Concomitant modulated electro-hyperthermia using the Oncotherm EHY-2030 device, 3 times per week, for 12 weeks 2. AC: Doxorubicin/Cyclophosphamide every three-weeks, 4x 3. Breast cancer tumor removal surgery (if feasible)
Receives: Device: Oncotherm EHY-2030; Drug: Paclitaxel; Drug: Carboplatin; Drug: Cyclophosphamide/Doxorubicin; Procedure: Breast cancer removal surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Residual size of the primary tumor, determined by imaging techniques (in percentage)

    Using breast MR measurements, the the residual size of the primary tumor will be specified for all patients (in percentage). The comparison of these between the two study arms will serve as the primary outcome measure.

    Calculation: The tumor size after the 6-months treatment period (in mm) will be divided by the size measured prior treatment (in mm). The quotient will be given as a percentage and subtracted from 100.

    Measured: change from baseline at 6 months

Secondary outcomes (12)

  1. Percentage of complete pathological response

    Comparison of the percentage of complete pathological responses between the two groups

    Measured: 9 months

  2. Treatment response patterns

    Comparison of the pathological response categories (pCR : pPR : pNR) between the two groups

    Measured: 9 months

  3. Comparison of surgical procedure ratios

    It will be compared whether the ratio of two main breast surgery types (breast-conserving surgery vs. total mastectomy) differ between the two study arms.

    Measured: 9 months

  4. Effect of treatment on white blood cell counts

    White blood cell counts (in G/L) will be measeured at every patient visit, and their longitudinal change will be analyzed using mixed-effect statistical modeling techniques.

    Measured: through study completion, an average of ~8 months

  5. Effect of treatment on red blood cell counts

    Red blood cell counts (in T/L) will be measeured at every patient visit, and their longitudinal change will be analyzed using mixed-effect statistical modeling techniques.

    Measured: through study completion, an average of ~8 months

  6. Effect of treatment on platelet counts

    Platelet counts (in G/L) will be measeured at every patient visit, and their longitudinal change will be analyzed using mixed-effect statistical modeling techniques.

    Measured: through study completion, an average of ~8 months

  7. Effect of treatment on hemoglobin levels

    Hemoglobin level of patients (in g/L) will be measeured at every patient visit, and their longitudinal change will be analyzed using mixed-effect statistical modeling techniques.

    Measured: through study completion, an average of ~8 months

  8. Effect of treatment on hematocrit levels

    Hematocrit level of patients (in L/L) will be measeured at every patient visit, and their longitudinal change will be analyzed using mixed-effect statistical modeling techniques.

    Measured: through study completion, an average of ~8 months

  9. Number of treatments where the planned power output of the Oncotherm EHY-2030 device could not be reached

    For an optimal treatment, the Oncotherm EHY-2030 device must reach its maximum output for 30 minutes. The number of treatments where this optimal outpur could not be reached will be reported.

    Measured: 3 months

  10. Longitudinal analysis of the EORTC QLQ-C30 questionnaire's total scores

    The European Organisation for Research and Treatment of Cancer 30-item quality of life questionnaire for cancer patients (EORTC QLQ-C30) total scores will be calculated as per the official quidelines, and their longitudinal change will be analyzed using mixed-effect statistical modeling techniques.

    Scoring of the questionnaire will be performed as per the official instructions of EORTC

    Measured: through study completion, an average of ~8 months

  11. Longitudinal analysis of the EORTC QLQ-BR23 questionnaire's total scores

    The European Organisation for Research and Treatment of Cancer 23-item quality of life questionnaire for breast cancer patients (EORTC QLQ-BR23) total scores will be calculated as per the official quidelines, and their longitudinal change will be analyzed using mixed-effect statistical modeling techniques.

    Scoring of the questionnaire will be performed as per the official instructions of EORTC

    Measured: through study completion, an average of ~8 months

  12. Longitudinal analysis of the EQ-5D-5L questionnaire scores

    The questionnaire will be assessed as per official guidelines.

    EuroQol's 5-dimension health-related quality of life instrument (EQ-5D-5L) questionnaire scores' longitudinal change will be analyzed using mixed-effect statistical modeling techniques.

    Scoring of the questionnaire will be performed as per the official instructions of EuroQol.

    Measured: through study completion, an average of ~8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2023
  2. Study start20 Feb 2023
  3. Primary completion31 Oct 2025
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05889390
Sponsor's protocol ID
NeoHTerMa
Acronym
NeoHTerMa
Status last verified
May 2026
First submitted
3 Mar 2023
Last updated
15 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Szasz AM, Minnaar CA, Szentmartoni G, Szigeti GP, Dank M. Review of the Clinical Evidences of Modulated Electro-Hyperthermia (mEHT) Method: An Update for the Practicing Oncologist. Front Oncol. 2019 Nov 1;9:1012. doi: 10.3389/fonc.2019.01012. eCollection 2019.

    PubMed 31737558

  • Herold Z, Szasz AM, Dank M. Evidence based tools to improve efficiency of currently administered oncotherapies for tumors of the hepatopancreatobiliary system. World J Gastrointest Oncol. 2021 Sep 15;13(9):1109-1120. doi: 10.4251/wjgo.v13.i9.1109.

    PubMed 34616516

  • Petenyi FG, Garay T, Muhl D, Izso B, Karaszi A, Borbenyi E, Herold M, Herold Z, Szasz AM, Dank M. Modulated Electro-Hyperthermic (mEHT) Treatment in the Therapy of Inoperable Pancreatic Cancer Patients-A Single-Center Case-Control Study. Diseases. 2021 Nov 3;9(4):81. doi: 10.3390/diseases9040081.

    PubMed 34842668

  • Szasz AM, Arrojo Alvarez EE, Fiorentini G, Herold M, Herold Z, Sarti D, Dank M. Meta-Analysis of Modulated Electro-Hyperthermia and Tumor Treating Fields in the Treatment of Glioblastomas. Cancers (Basel). 2023 Jan 31;15(3):880. doi: 10.3390/cancers15030880.

    PubMed 36765840

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Oncotherm EHY-2030, Paclitaxel and Carboplatin in people with HER2-negative Breast Cancer, run by Semmelweis University at 1 site in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Residual size of the primary tumor, determined by imaging techniques (in percentage) (time frame: change from baseline at 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05889390, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.

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