MASTER: Non Surgical Treatment (Microwave Ablation) of Breast Cancer
Study Details
Study Description
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?
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Microwave ablation Each patient will undergo Microwave ablation of breast tumor before the standard clinical care (surgery) |
Device: Microwave ablation
microwave ablation
|
Outcome Measures
Primary Outcome Measures
- MWA followed by MRI in breast tumors [1 year]
MWA will be succesfull if less than 20% of the patients has residual disease
Secondary Outcome Measures
- Cosmetic outcome [Timepoints 4 days and 2 weeks after MWA and timepoints 4 days, 2 weeks and 2 months after surgery]
Breast Q questionaire
- breast cancer recurrence fear [Timepoints 4 days and 2 weeks after MWA and timepoints 4 days, 2 weeks and 2 months after surgery]
Lerman Breast Cancer Worry scal
- Quality of life [Timepoints 4 days and 2 weeks after MWA and timepoints 4 days, 2 weeks and 2 months after surgery]
EuroQol 5D5L
Eligibility Criteria
Criteria
Inclusion Criteria:
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age should be 18 years and older
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a solid non-lobular invasive breast tumor with a size <2cm based upon ultrasound and MRI measurements
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without mammographic or MRI evidence of extensive disease
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no involved lymph nodes on ultrasound and MRI scan.
Exclusion Criteria:
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more than one breast tumor,
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(lymph node) metastases
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breast implants
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indication for neoadjuvant chemotherapy.
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pacemaker,
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pregnant
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breastfeeding
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University Medical Center Groningen
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NL76030.042.21
- 4901216