Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer

Study Overview
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Brief Summary
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This prospective, multicenter, 1:1 randomized, controlled trial is designed to evaluate the safety and effectiveness of the Breast Cancer Locator (BCL) in subjects with non-palpable invasive breast cancer or ductal carcinoma in situ (DCIS). Subjects will be randomized to breast conserving surgery (BCS) utilizing either the BCL or wire localization (WL) to guide surgery.

Detailed Description
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The BCL System is intended to be used to guide a surgeon when performing partial mastectomy for breast cancer and to minimize positive margins. The purpose of this study is to provide evidence that the BCL is safe, effective, and non-inferior to the standard of care (WL) in the removal of non-palpable invasive breast cancer and DCIS. Investigators in the intervention group will be provided with a three dimensional (3D) image of the cancer in the breast which allows them to visualize the closest distance from the tumor to the skin and the chest wall and quantifies those distances. Investigators will also use a BCL, which is a patient specific, plastic, bra-like form that is transiently placed on the breast prior to surgery and allows the Investigator to mark the projected edges of the tumor on the breast skin and to place bracketing wires inside the breast which define the center of the cancer and distances 1 cm from the tumor edges defined by pre-operative supine MRI.

Official Title
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Randomized Prospective Trial of Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer

Conditions
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Breast Cancer Female

Intervention / Treatment
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* Device: Breast Cancer Locator (BCL) guided partial mastectomy
* Device: Wire Localized (WL) partial mastectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female gender Age > 18 years Histologic diagnosis of invasive breast cancer or DCIS The surgeon determines that pre-operative tumor localization is required because the tumor cannot be definitively detected by palpation The tumor is unifocal; possible satellite lesions < or = 2 cm from primary are eligible The tumor enhances on prone breast MRI imaging The tumor is ≥ 1 cm in diameter on mammography or prone MRI Subject and surgeon agree to perform BCS Ability to voluntarily provide informed consent Exclusion Criteria: Absolute contraindication to MRI, including presence of implanted electrical device (e.g., pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes Severe claustrophobia Contraindication to use of gadolinium-based intravenous contrast, including life- threatening allergy Compromised renal function including chronic, severe kidney disease (GFR < 30 ml/min/1.73m2), or acute kidney injury Pregnancy - In women of childbearing age a urine pregnancy test will be performed Subjects who have received or plan to receive neoadjuvant chemotherapy Sternal notch to nipple distance of > 32 cm as measured in a sitting or standing position Measurement of widest circumference around breasts and arms > 135 cm Subjects with known allergy to materials present in the device Use of localization with devices other than a localization wire, including intraoperative ultrasound guidance, radiofrequency emitting implants, magnetic seeds, radioactive seeds, and tissue inspection devices (MarginProbe) Subject would require > 2 localization wires, if randomized to standard of care Multicentric tumors (additional tumors > 2 cm from primary)

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breast Cancer Locator (BCL)<br>Subject randomized to BCL surgical guidance to perform partial mastectomy | Device: Breast Cancer Locator (BCL) guided partial mastectomy<br>* The BCL is a patient-specific, plastic, bra-like form which is placed on the breast to localize the tumor during surgery.<br>|
| Active Comparator: Wire Localization (WL)<br>Subject randomized to WL surgical guidance to perform partial mastectomy | Device: Wire Localized (WL) partial mastectomy<br>* Standard of care procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive margin rate | To provide evidence that the positive margin rate following BCS using the BCL is not inferior to the standard of care (WL) for surgical guidance | At completion of study recruitment, approximately 18 months after first subject enrolled | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specimen volumes | To compare specimen volumes for women randomized to BCL vs. WL-guided BCS | At completion of study recruitment, approximately 18 months after first subject enrolled | 
| Re-excision rate | To compare re-excision rate for women randomized to BCL vs. WL-guided BCS | At completion of study recruitment, approximately 18 months after first subject enrolled | 
| Cancer localization rate | To compare cancer localization rate for women randomized to BCL vs. WL-guided BCS | At completion of study recruitment, approximately 18 months after first subject enrolled | 
| Operative times | To compare operative times for women randomized to BCL vs. WL-guided BCS | At completion of study recruitment, approximately 18 months after first subject enrolled | 
| Adverse event rate | To compare adverse event rate for women randomized to BCL vs. WL-guided BCS | At completion of study recruitment, approximately 18 months after first subject enrolled | 
| Rate of additional shave biopsies | To compare rate of additional shave biopsies for women randomized to BCL vs. WL-guided BCS | At completion of study recruitment, approximately 18 months after first subject enrolled | 
| Costs of care | To compare costs of care for women randomized to BCL vs. WL-guided BCS | At completion of study recruitment, approximately 18 months after first subject enrolled |