Minimal Invasive Breast Cancer Excision Using the Breast Lesion Excision System Under Ultrasound Guidance

Study Overview
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Brief Summary
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This study will assess whether it is feasible to remove small breast cancers completely using the Breast Lesion Excision System under Ultrasound guidance.

Detailed Description
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Rationale: In the Netherlands, ≥7000 women are operated for small breast cancers yearly. In this study, we will evaluate under which conditions it is possible to excise small breast cancers using the Breast Lesion Excision System (BLES) under ultrasound (US) guidance. When successful, this will allow ambulatory treatment of women with small breast cancers, improving the cosmetic outcome and quality of life. Objective: Our study aim is to assess whether it is feasible to remove small breast cancers completely using the BLES system under US guidance. Study design: This is a multi-centre, translational clinical phase II study in 125 women with cancers ≤1.5 cm based upon US measurements, and without mammographic evidence of more extensive disease (e.g. microcalcifications). Study population: Women with cancers ≤1.5 cm based upon US measurements, if there is no mammographic evidence of more extensive disease (e.g. microcalcifications or extensive architectural distortion), and the tumor lies ≥6 mm away from the dermis, nipple or pectoral muscle, are eligible for this study. Intervention: In 125 women with cancers ≤1.5 cm based upon US measurements, and without mammographic evidence of more extensive disease (e.g. microcalcifications), we will conduct additional preoperative breast MRI to ascertain lesion size, after informed consent has been obtained. If the lesion is confirmed ≤1.5 cm on MRI and lying ≥6 mm away from the dermis, nipple and pectoral muscle, the patient is eligible. Moreover, patients will be asked to fill out the questionnaire, detailing their risk profile and comorbidity index. Under general anaesthesia for the normal surgical procedure, the tumor is first removed using the BLES system under US guidance, through a small skin incision (<1 cm). Next, the normal surgical procedure is performed, excising the BLES excision cavity and a ≥ 1cm margin of surrounding tissue, also guided by the US appearance after the BLES procedure. Margin assessment will be performed separately for the BLES excision and the surgical specimen of the surrounding tissue. Main study parameters/endpoints: Main endpoint of the study is the frequency of successful complete tumor excision by the BLES system, where successful is defined as 'having tumor free margins, and no residual (in situ) cancer in the surgical specimen'. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Our approach allows to test the feasibility of this highly innovating approach to remove breast cancer, with minimal negative effects or possible complications. While there is no direct benefit nor detrimental effect from this study to the patients participating, the study has large implications for many women, as breast cancer remains the most common cancer in women, and due to screening, most cancers are small. Further reduction of the impact of local treatment is still desired as the psychosocial and somatic effects of breast deformation can be substantial.

Official Title
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Minimal Invasive Breast Cancer Excision Using the Breast Lesion Excision System Under Ultrasound Guidance

Conditions
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Breastcancer

Intervention / Treatment
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* Device: BLES system and conventional lumpectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female 19 years or older US visible breast cancer with maximum diameter of 15 mm on US Histologically proven invasive breast cancer Willing and able to undergo preoperative breast MRI Able to provide informed consent Exclusion Criteria: Poor US visibility of the breast cancer Breast cancer closer than 6 mm to the dermis, nipple or pectoral muscle. Contra-indications to breast MRI or intravenous contrast administration Contra-indications for the use of diathermia Unable to provide informed consent Patients with breast implants Patients with implanted electronics Pregnancy Neoadjuvant chemotherapy

Ages Eligible for Study
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Minimum Age: 19 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 |
| --- | --- |
| Experimental: Patients<br> | Device: BLES system and conventional lumpectomy<br>* Each patient undergoes the same procedure. Under general anaesthesia for the normal surgical procedure, the tumor is first removed using the BLES system under US guidance. Next, the normal surgical procedure is performed, excising the BLES excision cavity and a ≥ 1cm margin of surrounding tissue, also guided by the US appearance after the BLES procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of successful complete tumor excision by the BLES system. | Successful is defined as 'having tumor free margins, and no residual (in situ) cancer in the surgical specimen'. | Through study completion, an average of two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of the margin evaluation of the biopsy specimen and the eventual surgical specimen. |  | Through study completion, an average of two months | 
| In biopsy specimen in which the margin is not completely tumor free, but the Dutch criterion for successful surgery is met (no more than focal (4 mm) margin involvement), we will specifically analyse the residual tumor burden in the surgical excision. |  | Through study completion, an average of two months | 
| Assess in retrospect whether we can predict successful tumor extraction based upon other factors than tumor size alone. | Parameters categorized in: Patient related variables obtained from a questionnaire Lesion related variables Imaging features Surgical features Histopathological and molecular features from the core biopsy | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Minimal invasive, Biopsy