Breast cancer, carcinoma mammae Breast cancer
Conditions
Interventions
The intervention in this study is percutaneous cryoablation. This is a minimal invasive technique that percutaneously punctures the tumor using ultrasound guidance. The puncture place/skin is numbed u
The intervention is performed in an outpatient setting and the patient is monitored for two hours after the procedure and is then able to leave the hospital. 
Below is a description of the cryoablation mechanism of action:Cryoablation is based on cell death via the removal of heat. In 1964 Cooper, first described tissue necrosis at a temperature of -20°C or
immediate and delayed. The immediate effect is caused by the cycles of freezing and thawing. Because of high intracellular osmolality water freezes in the extracellular compartment before it does in t
Sponsors
Franciscus
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: To be eligible to participate in this study, a patient must meet all of the following criteria:WomenAge 60 years or olderPostmenopausal (no menstrual period for at least 12 months or in case of an intra-uterine device (IUD) hormone levels that indicate the menopause: follicle stimulating hormone (FSH) > 20 IE/l and estradiol < 100 pmol/l)Histopathological confirmed primary invasive ER+/HER2- type breast cancerBloom Richardson grade 1 or 2 (low or intermediate malignancy grade)Unilateral and unifocal breast cancer A clinical T1N0M0 tumor (= 2cm and N0 on US and/or MRI), without distant metastases. The largest diameter measured will be used to determine eligibility.Tumor should be visible and well delineated (all borders of the tumor should be visible) on ultrasound at diagnosis and during the procedure.Sufficient knowledge of the Dutch language to complete the questionnairesTo be able to give written informed consent
Exclusion criteria
Exclusion criteria: A potential study participant that meets any of the following criteria will be excluded from participation in this study:History of invasive breast cancerBreast augmentationBRCA-1 or 2 gene mutation carrierLobular carcinomaTriple negative breast cancerMultifocalityHER2-neu overexpressing tumorsLymph vascular invasion (LVI) on core needle biopsy or histopathological confirmed after lumpectomyIndication for neoadjuvant systemic therapyIntraductal component > 25% of the diameter of the invasive tumor on MRI, complete area of the primary tumor should not exceed 2cm.Allergic to local anaesthetics Electrical devices and/or implants that are not compatible with MRICurrent severe breast infectionUncorrectable coagulopathyHemodynamic instabilityRespiratory instabilityRefraining from adjuvant radiotherapyIndication for oncoplastic surgery (surgical volume replacement techniques e.g. LICAP)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of ipsilateral breast cancer recurrences (IBTR) after 5 years in both study arms. | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of complications within 30 days (percentage Clavien-Dindo classification).Regional breast cancer recurrences, defined as clinically, radiologically, and/or histologically confirmed recurrence in regional lymph nodes.Disease free survival (DFS) is defined as the time from date of intervention to the first occurrence of recurrent disease of the same histological characteristics as the primary tumor and in the same quadrant as the primary tumor.Overall survival (OS) is defined as the time from breast cancer diagnosis to death from any cause.The cosmetic outcomes using the BCTOS-13 and BREAST-Q questionnaires at baseline, 6 months after the procedure and after 1 year and objective cosmetic measurements using BCCT.core software at baseline, prior to radiation (6 or 12 weeks after intervention) and after 1 yearHospital-related costs, at 5 year post treatmentThe out-of-hospital medical and non-medical costs and productivity costs using the iMCQ and iPCQ questionnaires, and estimated incremental cost-utility ratio (ICUR) until 5 year post treatment Generic health-related quality of life using the EQ-5D-5L questionnaire before treatment, 6 months after, 1 year after and 5 years after treatment Disease-specific quality of life using EORTC-QLQ-C30/Br23 questionnaires before treatment, 6 months after, 1 year after and 5 years after treatment Complete ablation rate on magnetic resonance imaging at 2 weeks after the intervention (comparing residual MRI enhancement to baseline MRI).The negative predictive-, and diagnostic value of MRI for incomplete ablationThe proportion of reinterventions for incomplete ablation (percutaneous cryoablation group) and positive margins (breast-conserving surgery group)Any parameters that might affect complete ablation (e.g. breast density)The proportion of acute and long term breast irradiation toxicity (radiation dermatitis, superficial or deep connective tissue fibrosis, chest wall pain, localised edema) &n | — |
Countries
Netherlands
Contacts
Public ContactL Riks
Franciscus
Outcome results
None listed