Clinical trial NCT05887154: Non Surgical Treatment (Microwave Ablation) of Breast Cancer
Official title: Minimal Invasive Microwave Ablation in Early Stage breaST cancER, a Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer Stage I
Keywords: breast cancer
microwave ablation
MRI
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2023-06-02
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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?


Eligibility criteria: 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

Primary outcomes:
measure: MWA followed by MRI in breast tumors
timeFrame: 1 year
Secondary outcomes:
measure: Cosmetic outcome
timeFrame: Timepoints 4 days and 2 weeks after MWA and timepoints 4 days, 2 weeks and 2 months after surgery
measure: breast cancer recurrence fear
timeFrame: Timepoints 4 days and 2 weeks after MWA and timepoints 4 days, 2 weeks and 2 months after surgery
measure: Quality of life
timeFrame: Timepoints 4 days and 2 weeks after MWA and timepoints 4 days, 2 weeks and 2 months after surgery
Other outcomes:
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