Early-Stage Breast Cancer
Conditions
Keywords
Breast Cancer, Early-Stage Breast Cancer, Borstkanker, Vroegstadium Borstkanker
Brief summary
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.
Interventions
PROCEDUREPercutaneous cryoablation
In this trial, the IceCure Prosense Cryoablation System will be used to execute the percutaneous cryoablation procedure.
PROCEDUREBreast-conserving surgery
Breast-conserving surgery
Sponsors
Franciscus Gasthuis & Vlietland (Hospital)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Women 2. Age \> 60 years 3. Postmenopausal (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) 4. Histopathological confirmed primary invasive ER+/HER2- type breast cancer 5. Bloom Richardson grade 1 or 2 (low or intermediate malignancy grade) 6. Unilateral and unifocal breast cancer 7. 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. 8. Tumor should be visible and well delineated (all borders of the tumor should be visible) on ultrasound at diagnosis and during the procedure. 9. Sufficient knowledge of the Dutch language to complete the questionnaires 10. To be able to give written informed consent
Exclusion criteria
1. History of invasive breast cancer 2. Breast augmentation 3. BRCA-1 or 2 gene mutation carrier 4. Lobular carcinoma 5. Triple negative breast cancer 6. Multifocality 7. HER2-neu overexpressing tumors 8. Lymph vascular invasion (LVI) on core needle biopsy or histopathological confirmed after lumpectomy 9. Indication for neoadjuvant systemic therapy 10. Intraductal component \> 25% of the diameter of the invasive tumor on MRI, complete area of the primary tumor should not exceed 2cm. 11. Allergic to local anesthetics 12. Electrical devices and/or implants that are not compatible with MRI 13. Current severe breast infection 14. Uncorrectable coagulopathy 15. Hemodynamic instability 16. Respiratory instability 17. Refraining from adjuvant radiotherapy 18. Indication for oncoplastic surgery (surgical volume replacement techniques e.g. LICAP)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ipsilateral breast cancer recurrence | Until 5 years after the intervention | Proportion of ipsilateral breast cancer recurrences (IBTR) after 5 years in both study arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication Rate | Within 30 days after the intervention | The proportion of complications within 30 days (percentage Clavien-Dindo classification). |
| Regional breast cancer recurrences | Until 5 years after the intervention | Regional breast cancer recurrences, defined as clinically, radiologically, and/or histologically confirmed recurrence in regional lymph nodes. |
| Disease Free Survival | until 15 years after the intervention | 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 | through study completion, an average of 15 years | Overall survival (OS) is defined as the time from breast cancer diagnosis to death from any cause. |
| Cosmetic Outcomes | at baseline, 6 months and 1 year after the intervention | 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. |
| Hospital-related costs | Until 5 years after the intervention | Hospital-related costs, including expenses made due to additional findings on inclusion MRI |
| Out-of-hospital (non)-medical costs | Until 5 years after the intervention | 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. |
| Generic Health-related Quality of Life | At baseline, 6 months after the intervention, 1 and 5 years after the intervention | To assess general health-related quality of life using the EQ-5D-5L questionnaire, with higher scores indicating better health status |
| Disease-specific quality of life | At baseline, 6 months after the intervention, 1 and 5 years after the intervention | 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. |
| Complete ablation rate | 2 weeks after the intervention (cryoablation) | On magnetic resonance imaging |
| Predictive value of MRI | until 5 years after the intervention | The negative predictive-, and diagnostic value of MRI for incomplete ablation |
| Proportion of reinterventions | For the duration of the study, most likely within 2 weeks after the intervention | For both study arms. |
| Radiation Toxicity | At baseline, prior to radiation, 1 year and 5 years after the intervention | 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 |
| Incremental cost-utility ratio (ICUR) | Until 5 years after the intervention | To estimate the incremental cost-utility ratio (ICUR). Higher ICUR values indicate higher costs per quality-adjusted life year (QALY) gained. |
Contacts
CONTACTLinda Riks, MD
PRINCIPAL_INVESTIGATORT.M.A.L. GE Klem, MD, PhD
Franciscus Gasthuis & Vlietland
Outcome results
None listed