The goal of this randomised controlled trial is to compare ipsilateral breast cancer recurrence rates in patients with early-stage breast cancer between patients treated with breast conserving surgery and patient treated with percutaneous cryo-ablation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
938
In this trial, the IceCure Prosense Cryoablation System will be used to execute the percutaneous cryoablation procedure.
Breast-conserving surgery
Ipsilateral breast cancer recurrence
Proportion of ipsilateral breast cancer recurrences (IBTR) after 5 years in both study arms.
Time frame: Until 5 years after the intervention
Complication Rate
The proportion of complications within 30 days (percentage Clavien-Dindo classification).
Time frame: Within 30 days after the intervention
Regional breast cancer recurrences
Regional breast cancer recurrences, defined as clinically, radiologically, and/or histologically confirmed recurrence in regional lymph nodes.
Time frame: Until 5 years after the intervention
Disease Free Survival
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
Time frame: until 15 years after the intervention
Overall Survival
Overall survival (OS) is defined as the time from breast cancer diagnosis to death from any cause.
Time frame: through study completion, an average of 15 years
Cosmetic Outcomes
o assess cosmetic outcomes following treatment with cryoablation or lumpectomy using the BCTOS-13 and BREAST-Q questionnaires at specified follow-up visits, and objective assessment using BCCT.core software. Higher scores indicate better cosmetic outcomes.
Time frame: at baseline, 6 months and 1 year after the intervention
Hospital-related costs
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Hospital-related costs, including expenses made due to additional findings on inclusion MRI
Time frame: Until 5 years after the intervention
Out-of-hospital (non)-medical costs
To assess out-of-hospital medical and non-medical costs and productivity losses using the iMTA Medical Consumption Questionnaire (iMCQ) and iMTA Productivity Cost Questionnaire (iPCQ) questionnaires.
Time frame: Until 5 years after the intervention
Generic Health-related Quality of Life
To assess general health-related quality of life using the EQ-5D-5L questionnaire, with higher scores indicating better health status
Time frame: At baseline, 6 months after the intervention, 1 and 5 years after the intervention
Disease-specific quality of life
To assess cancer-specific quality of life using the EORTC QLQ-C30 and EORTC QLQ-BR23 questionnaires. Higher scores indicate better functioning or greater symptom burden depending on the subscale.
Time frame: At baseline, 6 months after the intervention, 1 and 5 years after the intervention
Complete ablation rate
On magnetic resonance imaging
Time frame: 2 weeks after the intervention (cryoablation)
Predictive value of MRI
The negative predictive-, and diagnostic value of MRI for incomplete ablation
Time frame: until 5 years after the intervention
Proportion of reinterventions
For both study arms.
Time frame: For the duration of the study, most likely within 2 weeks after the intervention
Radiation Toxicity
The proportion of acute and long-term breast irradiation toxicity (radiation dermatitis, superficial or deep connective tissue fibrosis, chest wall pain, localized edema) using common toxicity criteria (CTCAE v5.0) and cosmetic questionnaires
Time frame: At baseline, prior to radiation, 1 year and 5 years after the intervention
Incremental cost-utility ratio (ICUR)
To estimate the incremental cost-utility ratio (ICUR). Higher ICUR values indicate higher costs per quality-adjusted life year (QALY) gained.
Time frame: Until 5 years after the intervention