Neoadjuvant Concomitant Modulated Electro-hyperthermia in HER2-negative Breast Cancer (NCT05889390) | Clinical Trial Compass
Active — Not RecruitingPhase 2/3
Neoadjuvant Concomitant Modulated Electro-hyperthermia in HER2-negative Breast Cancer
Hungary71 participantsStarted 2023-02-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. Primary breast tumor ≥ 20 mm in size and/or
. Presence of axillary lymph node metastases
Exclusion criteria
. Patient is ≤ 18 years of age.
. Tumor of both breasts.
. Diagnosis of breast tumor \> 40 days
. HER2 positive breast tumor
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Residual size of the primary tumor, determined by imaging techniques (in percentage)
. 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.
. Co-existing serious diseases:
. Presence of severe neuropathy requiring medical treatment, diabetic neuropathy.