Clinical trial NCT04397185: Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer
Official title: Randomized Prospective Trial of Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Female
Lead sponsor: CairnSurgical, Inc.
Sponsor class: INDUSTRY
First posted: 2020-05-21
Enrollment: 448
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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 or multifocal with satellite lesions \< or = 2 cm from primary tumor
* The tumor enhances on prone breast MRI imaging
* The tumor is ≥ 1 cm in diameter on prone breast MRI
* Subject and surgeon agree to perform BCS
* Subject voluntarily provides 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 that precludes prone or supine MRI
* 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 potential, 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 for sites using 60cm bore scanners, and measurement of widest circumference around breasts and arms \>145 cm for sites using 70 cm bore scanners
* 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
* Subjects with multicentric tumors (additional tumors \> 2 cm from primary)
* Subject would require chest wall muscle nerve block as part of the operation

Primary outcomes:
measure: Positive margin rate
timeFrame: At completion of study recruitment, approximately 18 months after first subject enrolled
Secondary outcomes:
measure: Specimen volumes
timeFrame: At completion of study recruitment, approximately 18 months after first subject enrolled
measure: Re-excision rate
timeFrame: At completion of study recruitment, approximately 18 months after first subject enrolled
measure: Cancer localization rate
timeFrame: At completion of study recruitment, approximately 18 months after first subject enrolled
measure: Operative times
timeFrame: At completion of study recruitment, approximately 18 months after first subject enrolled
measure: Adverse event rate
timeFrame: At completion of study recruitment, approximately 18 months after first subject enrolled
measure: Rate of additional shave biopsies
timeFrame: At completion of study recruitment, approximately 18 months after first subject enrolled
measure: Costs of care
timeFrame: At completion of study recruitment, approximately 18 months after first subject enrolled
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Arizona Center for Cancer Care
state: Arizona
city: Walnut Creek
country: United States
facility: BASS Medical Group
state: California
city: Jacksonville
country: United States
facility: Baptist MD Anderson Cancer Center
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Danvers
country: United States
facility: Mass General/North Shore Center for Outpatient Care
state: Massachusetts
city: Easton
country: United States
facility: Steward Medical Group
state: Massachusetts
city: Minneapolis
country: United States
facility: Hennepin Healthcare
state: Minnesota
city: Keene
country: United States
facility: Cheshire Medical Center
state: New Hampshire
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Manchester
country: United States
facility: Catholic Medical Center
state: New Hampshire
city: Nashua
country: United States
facility: St. Joseph Hospital
state: New Hampshire
city: Florham Park
country: United States
facility: Summit Health
state: New Jersey
city: Albany
country: United States
facility: St. Peter's Hospital
state: New York
city: Brooklyn
country: United States
facility: Kings County Hospital Center
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center and New York-Presbyterian Hospital
state: New York
city: Nyack
country: United States
facility: Montefiore Nyack Hospital
state: New York
city: Columbus
country: United States
facility: The Ohio State University Comprehensive Cancer Center
state: Ohio
city: Providence
country: United States
facility: Women and Infants Hospital
state: Rhode Island
city: Warwick
country: United States
facility: Kent Hospital
state: Rhode Island
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Bennington
country: United States
facility: Southwestern Vermont Medical Center
state: Vermont
city: Rutland
country: United States
facility: Rutland Regional Medical Center
state: Vermont
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: London
country: United Kingdom
facility: Royal Free London NHS Trust
city: Manchester
country: United Kingdom
facility: Manchester University NHS
Study officials:
affiliation: Women & Infants Hospital
name: Jennifer Gass, MD
role: PRINCIPAL_INVESTIGATOR
References: