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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients will be treated with ultrasound-guided percutaneous cryoablation | Active Comparator | Ultrasound-guided percutaneous cryoablation |
|
| Breast-conserving surgery | Other | Patients will be treated with breast-conserving surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous cryoablation | Procedure | In this trial, the IceCure Prosense Cryoablation System will be used to execute the percutaneous cryoablation procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ipsilateral breast cancer recurrence | Proportion of ipsilateral breast cancer recurrences (IBTR) after 5 years in both study arms. | Until 5 years after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Complication Rate | The proportion of complications within 30 days (percentage Clavien-Dindo classification). | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Any other parameters | To explore patient- or tumor-related factors that may influence complete ablation or surgical outcomes, including breast density and other relevant parameters. | until the end of the study, which is an average of 5 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Linda Riks, MD | Contact | 010 - 893 6010 | l.riks@franciscus.nl |
| Name | Affiliation | Role |
|---|---|---|
| T.M.A.L. GE Klem, MD, PhD | Franciscus Gasthuis & Vlietland | Principal Investigator |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D020728 | Transurethral Resection of Prostate |
| D015412 | Mastectomy, Segmental |
| ID | Term |
|---|---|
| D011468 | Prostatectomy |
| D013521 | Urologic Surgical Procedures, Male |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
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This is a multicenter randomized phase III non-inferiority trial with two arms: percutaneous cryoablation and breastconserving surgery. The randomization ratio is 1:1, stratified by center, tumor size (< / > 1 cm) and Bloom Richardson grade. All eligible patients will consecutively be included and randomized. Crossover is only possible for patients allocated to the cryoablation arm.
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|
| Breast-conserving surgery | Procedure | Breast-conserving surgery |
|
|
| 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 | 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. | 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. | at baseline, 6 months and 1 year after the intervention |
| Hospital-related costs | Hospital-related costs, including expenses made due to additional findings on inclusion MRI | 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. | 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 | 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. | At baseline, 6 months after the intervention, 1 and 5 years after the intervention |
| Complete ablation rate | On magnetic resonance imaging | 2 weeks after the intervention (cryoablation) |
| Predictive value of MRI | The negative predictive-, and diagnostic value of MRI for incomplete ablation | until 5 years after the intervention |
| Proportion of reinterventions | For both study arms. | 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 | 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. | Until 5 years after the intervention |
| D017437 |
| Skin and Connective Tissue Diseases |
| D013514 | Surgical Procedures, Operative |
| D008408 | Mastectomy |