Ignite Creation Date:
2024-05-06 @ 7:04 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05889390
Status:
RECRUITING
Last Update Posted:
2023-06-05
First Post:
2023-03-03
Brief Title:
Neoadjuvant Concomitant Modulated Electro-hyperthermia in HER2-negative Breast Cancer
Sponsor:
Semmelweis University
Organization:
Semmelweis University
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NeoHTerMa
Brief 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 11 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None