Breast cancer surgeons and researchers at Penn Medicine are participating in a multi-center study (ClinicalTrials.gov Identifier: NCT03892980) to evaluate robotic-assisted prophylactic nipple-sparing mastectomy (NSM) in women at increased risk for breast cancer. The principal investigator for the study at Penn Medicine is Ari Brooks, MD.
Breast cancer remains the most common cancer in women worldwide, and more than 225,000 invasive breast cancer cases are diagnosed each year in North America and Western Europe alone. The prognosis for women with BRCA1 and BRCA2 mutations is particularly concerning, as it is estimated that 60-75% of women with BRCA1 mutation and 50-70% of women with a BRCA2 mutation will develop breast cancer by age 70.
The options for women at high risk for breast cancer include surveillance, chemoprevention and prophylactic mastectomy and/or oophorectomy. Bilateral prophylactic mastectomy has been shown to reduce the risk of breast cancer by 95% in women who have a deleterious mutation in the BRCA1 or BRCA2 genes and by up to 90% in women who have a strong family history of breast cancer.
Advantages of Prophylactic Nipple-Sparing Mastectomy
The techniques available for prophylactic mastectomy include total, modified radical, skin-sparing and nipple-sparing surgeries. Nipple-sparing mastectomy (NSM) with reconstruction technology offers the opportunity to preserve the shape of both the breast and the nipple – areola complex. However, because it spares a portion of breast tissue, NSM been the object of some concern with regard to cancer risk. According to a recent evaluation by the American Society of Breast Surgeons (ASBS), this estimation is evolving, with the result that a larger population of women have become eligible for NSM. Among other findings for NSM, the ASBS report cites a better understanding of breast anatomy, advances in technique, and positive studies in outcomes, patient satisfaction, and infection rates. [2]
NSM Techniques
The evolution of NSM has involved a committed effort to improve upon safety and technique. The advent of robotic techniques enhanced the technical limitations of endoscopy (a previously introduced minimally invasive approach), allowing endoscopic NSM to achieve a safety profile similar to that of open surgery. Moreover, the smaller incisions of NSM brought the potential for better cosmetic outcomes.
About the Robotic-Assisted da Vinci Xi Prophylactic Nipple-Sparing Mastectomy Study
The goal of the study taking place at Penn Medicine is to evaluate the safety and effectiveness of the da Vinci Xi Surgical System, instruments, and accessories in NSM procedures.
Efficacy and Safety Endpoints
The primary effectiveness endpoint will evaluate the ability of the da Vinci Xi Surgical System to complete the NSM procedure without the need for converting to an open approach. The primary safety endpoint will evaluate the robotic procedure for incidence of intraoperative device-related adverse events, and post-operative adverse events occurring through a 42-day follow-up period. This data will be compared to a performance goal based on published rates reported for open NSM surgeries. Participants will be followed on an annual basis for 5 years to assess the occurrence of breast cancer, adverse events and Patient Reported Outcomes (PROs).
Eligibility and Participation
Participants in the Robotic-Assisted NSM study must be female, between the ages of 18 and 80, have a BMI <29, and be a candidate for unilateral or bilateral nipple-sparing mastectomy with immediate one-stage or two-stage reconstruction.
Furthermore, participants should be at increased risk for breast cancer and seeking prophylactic NSM surgery, or have breast cancer in one breast and be seeking prophylactic NSM on the contralateral side. The participant should have no presence of occult cancer on the side for which she is seeking prophylactic NSM surgery as confirmed by physical exam and by preoperative imaging per institution's guidelines. Known carriers of pathogenic BRCA1/2 mutations should have negative breast MRI.
Additional inclusion and exclusion criteria is available from the study description at clinicaltrials.gov.
For referral information for this study, please contact: Juliana.Ruiz@Pennmedicine.upenn.edu
Study Location
Pennsylvania Hospital
Integrated Breast Center
Farm Journal Building
230 West Washington Square
Philadelphia, PA 19106
References
- Surgery to Reduce the Risk of Breast Cancer | NIH Fact Sheet. Available at https://www.cancer.gov/types/breast/risk-reducing-surgery-fact-sheet.
- Mitchell SD, Willey SC, Beitsch P, Feldman S. Evidence based outcomes of the American Society of Breast Surgeons Nipple Sparing Mastectomy Registry. Gland Surg 2017;7:247-257.
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