HER2-negative Breast Cancer Clinical Trial
— NeoHTerMaOfficial 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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | April 30, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. At least 18 years of age 2. Female patient 3. Life expectancy = 6 months 4. De novo histological/cytological diagnosis of HER2-negative (triple-negative or ER/PR+) breast tumor involving one breast 5. Diagnosis of breast tumor = 40 days 6. Locally advanced stage disease (stage II and III) requiring neoadjuvant treatment - according to the following criteria: 1. Primary breast tumor = 20 mm in size and/or 2. Presence of axillary lymph node metastases 3. Optimal surgical intervention without neoadjuvant chemotherapy is not feasible 7. ECOG status: 0-2 8. Suitable for and designated by the investigator for neoadjuvant therapy with wTAX + (carboplatin) + AC chemotherapeutic agent 9. Willingness to participate in the trial and signed the informed consent form for the protocol Exclusion Criteria: 1. Patient is = 18 years of age. 2. Tumor of both breasts. 3. Diagnosis of breast tumor > 40 days 4. HER2 positive breast tumor 5. Has already received some anticancer therapy 6. 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. 7. Co-existing serious diseases: 1. Presence of severe neuropathy requiring medical treatment, diabetic neuropathy. 2. 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. 3. 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). 4. Uncontrolled hypertension with resting systolic = 180 mmHg, resting diastolic = 110 mmHg. 5. Resting sinus tachycardia with a pulse = 110/min. 6. History of sympathetic or treatment-naive cardiac arrhythmia. Atrial fibrillation or flutter controlled with medication is not an exclusion for participation in the study. 7. Major cardiovascular event (e.g. myocardial infarction, unstable angina, cerebral vascular accident (CVA), etc.) in the 6 months prior to randomisation. 8. 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. 9. 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. 8. Need for concomitant anti-tumor therapy in addition to wTAX + (carboplatin) + AC protocol 9. Any active medical device implanted in the anatomical area, such as pacemakers. 10. Known severe hypersensitivity to any of the chemotherapies used in the study. 11. 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. 12. History of drug or alcohol dependence within 6 months prior to screening. 13. Unable to comply with the study plan for medical, psychological, family, geographical or other reasons. 14. Institutionalisation by administrative or judicial decision. |
Country | Name | City | State |
---|---|---|---|
Hungary | Division of Oncology, Department of Internal Medicine and Oncology, Semmelweis University | Budapest |
Lead Sponsor | Collaborator |
---|---|
Semmelweis University |
Hungary,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Incidence of Treatment-Emergent Adverse Events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. | All adverse events will be assessed and classified by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Using descriptive statistics, the number of occurrances will be listed for both study arms. |
through study completion, an average of ~8 months | |
Primary | 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. |
change from baseline at 6 months | |
Secondary | Percentage of complete pathological response | Comparison of the percentage of complete pathological responses between the two groups | 9 months | |
Secondary | Treatment response patterns | Comparison of the pathological response categories (pCR : pPR : pNR) between the two groups | 9 months | |
Secondary | 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. | 9 months | |
Secondary | 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. | through study completion, an average of ~8 months | |
Secondary | 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. | through study completion, an average of ~8 months | |
Secondary | 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. | through study completion, an average of ~8 months | |
Secondary | 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. | through study completion, an average of ~8 months | |
Secondary | 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. | through study completion, an average of ~8 months | |
Secondary | 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. | 3 months | |
Secondary | 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 |
through study completion, an average of ~8 months | |
Secondary | 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 |
through study completion, an average of ~8 months | |
Secondary | 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. |
through study completion, an average of ~8 months |
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