Are you frustrated by outcomes in Breast Conserving Surgery?

 

Breast conserving surgery is unsuccessful in removing the entire tumor 20% of the time, resulting in a positive tumor margin upon pathology analysis. This typically means the woman will need to undergo additional surgery.

A new clinical trial is studying whether the investigational Breast Cancer Locator System used during surgery can improve a surgeon’s ability to reduce positive margins.

About the Breast Cancer Locator Trial

 

 

The Breast Cancer Locator Trial is a prospective, multicenter, 1:1 randomized, controlled pivotal trial of the Breast Cancer Locator System used to guide partial mastectomy for breast cancer compared to traditional wire localization.

Target Enrollment:

448 Women

15 U.S. Centers

 A roll-in phase encompassing up to 15 additional patients (maximum of 1 patient per site) may be included from centers that do not have previous experience with the BCL before randomization begins.

Endpoints

Primary Endpoint
  • Positive margin rate in comparison to traditional wire localization
Other Endpoints
  • Specimen volumes
  • Rate of additional shave biopsies
  • Re-excision rate
  • Cancer localization rate
  • Operative time
  • Cost of care
  • Adverse events

Who is the right subject?

Key inclusion criteria

  • Women >18 years
  • Histologic diagnosis of invasive breast cancer or DCIS
  • Non-palpable, unifocal tumor; possible satellite lesions ≤ 2cm from primary are eligible
  • Tumor ≥ 1cm in dimeter visible on prone breast MRI imaging and mammography
Key exclusion criteria
  • Absolute contraindication to MRI, including presence of implanted medical device (e.g., pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes
  • Contraindication to use of gadolinium-based intravenous contrast, including life-threatening allergy
  • Severe claustrophobia
  • Compromised renal function, including chronic, severe kidney disease or acute kidney injury
  • Pregnancy
  • Previous or planned neoadjuvant chemotherapy
  • Sternal notch-to-nipple distance of > 32cm
  • > 135cm circumference around breasts and arms
  • Known allergy to materials in device
  • Use of localization with devices other than a localization wire
  • Multicentric tumors (additional tumors > 2cm from primary tumor)

About the Breast Cancer Locator

“Breast cancer surgery today leaves cancer in the breast in more than one in five cases – as a surgeon myself, that’s just unacceptable. Positive tumor margins, and thus, typically, re-excision surgery to go back into the breast, is bad for the patient, and it’s expensive and it’s painful. We invented the Breast Cancer Locator with the vision to enable a surgeon to reduce positive tumor margins.”

Richard Barth, Jr., MD

Chief of General Surgery, Dartmouth-Hitchcock Medical Center
Professor of Surgery, Geisel School of Medicine at Dartmouth
Co-founder, CairnSurgical (developer of the Breast Cancer Locator)

The problem is that current wire localization techniques used ahead of surgery, and implantable seeds and tags, do not facilitate precise surgery. They tell surgeons nothing about tumor size, shape, edges or margins. The Breast Cancer Locator System includes three steps:

A supine MRI image is first performed with the breast positioned in its surgical position providing precise detail on the size, shape, depth, edges and 1 centimeter margin for the tumor. This imagery is used to analyze the tumor and construct a three-dimensional tumor model that serves as the basis for two surgical tools.

A 3D-printed form – the Breast Cancer Locator, or BCL – is produced that fits the unique shape of the patient’s breast, with ports for central and bracketing wires placed under anesthesia in surgery. This is designed to guide the surgeon to the precise tumor boundaries and margins.

An interactive 3D image – the Visualizer – offers visualization of the tumor and quantification of the closest distance from the tumor to the skin and chest wall.

Participating Centers

Dartmouth-Hitchcock Nashua
St. Joseph Hospital Rehabilitation
2300 Southwood Drive
Nashua, NH 03063
Ph: 603.577.4141

MD Anderson Cancer Center
Breast Surgical Oncology
1400 Pressler Unit 1434
Houston, TX 77030-4008
Ph: 713.792.5031

Women and Infants Program in Women’s Oncology Breast Health Center
101 Dudley Street
Providence, RI 02905
Ph: 401.453.7540

Catholic Medical Center – Breast Care Center
Bedford Medical Park
9 Washington Place
Bedford, NH 03110
Ph: 603.663.5270

Baptist MD Anderson Cancer Center
1301 Palm Avenue
Jacksonville, FL  32207
Ph: 844.632.2278

Norris Cotton Cancer Center
Dartmouth-Hitchcock Medical Center
One Medical Center Drive
Lebanon, NH 03756-3500
Ph: 603.650.4344

Mass General/North Shore Center for Outpatient Care
104 Endicott Street, Suite 200
Danvers, MA 01923
Ph: 978.882.6899

Southwestern Vermont Health Care (SVHC)
100 Hospital Drive
Bennington, VT 05201
Ph: 802.442.6361

Cheshire Medical Center Dartmouth-Hitchcock Keene General Surgery
580 Court St
Keene, NH 03431
Ph: 603.354.5400

Moffitt Cancer Center Magnolia Campus
12902 USF Magnolia Drive
Tampa, FL 33612
Ph: 813.745.4673

St Peter’s Health Partners Cancer Care Center
317 South Manning Boulevard, Suite 220
Albany, New York 12208
Ph: 518.525.6418

Rutland Regional Medical Center
160 Allen Street
Rutland, VT 05701
Ph: 802.775.7111

For Subjects

12% of women develop invasive breast cancer during their lifetime.

80% of breast cancer tumors are irregularly shaped, making it difficult for surgeons to identify the tumor edges and margins.

20% of breast conserving surgeries will result in positive tumor margins upon pathology analysis, which could mean that some cancer is remaining in the breast.

About one in eight women will develop invasive breast cancer during her lifetime.

Breast conserving surgery is successful about 80 percent of the time in removing the entire tumor. However, one in five women with breast cancer must undergo a second surgery when some of the cancer is missed.

 

The issue is not a surgeon’s skills; it is the lack of technology to provide enough information about the tumor to aid the surgeon.

According to a recent study on breast cancer tumor shapes, fewer than 20 percent of breast cancer tumors are round. When the shape is irregular, it can be challenging for surgeons to easily identify its edges in order to remove all of it.

A new clinical trial is studying whether the investigational Breast Cancer Locator System used during surgery can improve a surgeon’s ability to reduce positive margins.

CAUTION – Investigational device. Limited by Federal (or United States) law to investigational use

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