Non Surgical Treatment (Microwave Ablation) of Breast Cancer

Study Overview
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Brief Summary
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In the Netherlands approximately one out of seven women will develop breast cancer during her life. Most of these breast cancers are early stage, 40% of the women have stage 1. Stage 1 breast cancer means that the cancer is small (size <2cm) and only in the breast tissue or it might be found in lymph nodes close to the breast. The standard treatment for stage 1 breast cancer is breast conserving surgery (BCS), sentinel lymph node procedure (SLNP) and additional radiotherapy. This standard treatment protocol results in a10 years survival rate of 95% for stage 1 disease. However, nowadays there is a discussion whether these early stage breast cancer could be treated less invasively. To reduce the invasiveness of breast cancer treatment, without compromising breast cancer specific survival, minimally invasive ablation procedure of the breast tumor can be an option for small breast lesions. Patients with a tumor size<2 cm will undergo ultra guided microwave ablation (MWA) with local anesthesia. After a small incision 2-3 millimeters, an MWA electrode is placed at the end of the tumor with ultrasound guidance. The microwaves in MWA create heat around the needle and destroy the cancer cells. There are several advantages of ablation procedures: it is a minimal invasive technique, with a small or absent cutaneous scar and thereby potentially improving patient quality of life. Furthermore, ablative treatment can be done under local anesthesia and/or conscious sedation instead of general anesthesia and in daycare setting, which can reduce treatment cost. A post procedural MRI (after ablation) can determine whether the ablation procedure of the tumor volume is complete. The purpose of this study is to assess whether minimally invasive microwave ablation (MWA) followed by postprocedural MRI scan can be an alternative treatment for breast surgery in early stage breast cancer. Is the quality of life, the cosmetic outcome, fear of breast cancer recurrence, and costs in patient treated with MWA comparable or better compared to patients treated with breast surgery?

Official Title
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Minimal Invasive Microwave Ablation in Early Stage breaST cancER, a Feasibility Study

Conditions
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Breast Cancer Stage I

Intervention / Treatment
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* Device: Microwave ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age should be 18 years and older a solid non-lobular invasive breast tumor with a size <2cm based upon ultrasound and MRI measurements without mammographic or MRI evidence of extensive disease no involved lymph nodes on ultrasound and MRI scan. Exclusion Criteria: more than one breast tumor, (lymph node) metastases breast implants indication for neoadjuvant chemotherapy. pacemaker, pregnant breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Microwave ablation<br>Each patient will undergo Microwave ablation of breast tumor before the standard clinical care (surgery) | Device: Microwave ablation<br>* microwave ablation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MWA followed by MRI in breast tumors | MWA will be succesfull if less than 20% of the patients has residual disease | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cosmetic outcome | Breast Q questionaire | Timepoints 4 days and 2 weeks after MWA and timepoints 4 days, 2 weeks and 2 months after surgery | 
| breast cancer recurrence fear | Lerman Breast Cancer Worry scal | Timepoints 4 days and 2 weeks after MWA and timepoints 4 days, 2 weeks and 2 months after surgery | 
| Quality of life | EuroQol 5D5L | Timepoints 4 days and 2 weeks after MWA and timepoints 4 days, 2 weeks and 2 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, microwave ablation, MRI