Percutaneous Cryoablation of Low-risk Early Breast Cancer (NCT06300125) | Clinical Trial Compass
RecruitingNot Applicable
Percutaneous Cryoablation of Low-risk Early Breast Cancer
Italy234 participantsStarted 2024-04-15
Plain-language summary
Expand the current evidence base regarding percutaneous cryoablation of early-stage, low-risk breast tumors, integrated into the standard therapeutic pathway with well-defined follow-up data, as well as data on quality of life. Demonstrate, therefore, that the use of percutaneous cryoablation in the treatment of low-risk breast carcinoma is not inferior to surgery when combined with adjuvant radiotherapy and chemotherapy (when necessary). The hypothesis is that cryoablation, being simple and oncologically effective, ensures a better quality of life for the patient (reduced morbidity, no need for general anesthesia, improved cosmetic outcomes) and consequently has a lesser psychological impact, as well as a better cost-benefit ratio compared to the standard surgical approach.
Who can participate
Age range
50 Years
Sex
ALL
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:
* Tumour, Node, Metastasis stage (TNM) = dimension up to 15 mm as measured by breast ultrasound, MRI, Mammography, Node negative, absence of distant metastasis
* Unifocality
* All invasive cancer, except lobular
* Biology= luminal A and luminal B\* (Estrogen Receptor (ER) positive/human epidermal growth factor receptor-2 (HER2)negative) (Documented estrogen receptor (ER)-positive tumor assessed locally and defined as ≥10% of tumor cells stained positive.
Documented HER2-negative tumor (in accordance to 2018 American Society of Clinical Oncology guidelines, as determined per local assessment)
* Any grade (G)
* Radiological detection= breast ultrasound, MRI, Mammography
* Tumor site= not located superficially (≥1 cm from the skin plane)
* Breast size= any, appropriate for the procedure in relation to ultrasound examination
* Referral to breast cryoablation by a multidisciplinary tumor board
* Planned treatment with cryoablation using IceCure (TM-trade mark) system
* Informed consent \*Luminal B and G3 BC: previous specific patients' selection and Oncotype Dx \[31\] on cancer tissue from needle biopsy before procedure and eventual Prediction Analysis of Microarray 50 (PAM50) test.
Exclusion Criteria:
* Plurifocality
* Invasive lobular breast cancer
* HER2 overexpressed or Triple Negative Breast Cancer (TNBC)
* tumor dimension \>15 mm
* Node positive
* post NeoAdjuvant ChemoTherapy (NACT) breast cancer
* \<50 years
* Presence of intraductal component (DCI…
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.