Duke Cancer Institute (DCI) is one of the 15 medical centers — and the only in North Carolina — participating in a randomized controlled study comparing outcomes of robotic-assisted nipple-sparing mastectomy and current standard-of-care open surgical techniques to treat early-stage breast cancer. Akiko Chiba, MD, breast surgical oncologist, leads the study. 

“Robotic surgery on many other parts of the body has become an accepted option, but this study is novel in its application in the breast for the nipple-sparing mastectomy,” says Chiba. “Other studies have shown feasibly and safety and hope this study supports more evidence of oncologic safety to have robotic mastectomy an option for patients in the future.” 

“Earlier studies report that if nipple-sparing surgery is done robotically, women are more likely to heal faster due to smaller incisions that are only 3.5 cm, retain sensation, and achieve improved aesthetic outcomes. These studies show that patient-reported outcomes are better with robotic surgery, as well as psychological well-being. These are important quality-of-life measures in survivorship,” says Chiba. “There’s also evidence that this procedure has equivalent success in achieving negative margin rates.” 

For the study, eligible participants are randomly placed into one of two groups: those undergoing the robotic-assisted procedure and those having open surgery, both immediately followed by implant-based reconstruction. Participants are followed for five years to track and compare the outcomes of both procedures.

“Patients who might benefit most from this study are those with early-stage breast cancer who are appropriate for nipple-sparing mastectomy and immediate implant reconstruction,” says Chiba. Additional inclusion criteria are being a female 21 years or older with a BMI less than 30 and a breast cup size C or smaller diagnosed with early stage breast cancer. 

Patients who have had prior breast surgery, a diagnosis of metastatic breast cancer, or previous radiation to the chest do not qualify for the study. Additional exclusion criteria include current smoking, pregnancy, or breastfeeding.

Robotic minimally invasive surgery is only one part of the trial — patients also undergo immediate implant reconstruction performed by DCI breast reconstructive surgeons involved in the trial, Geoffroy C. Sisk, MD, and Rebecca Knackstedt, MD, PhD. 

“We work closely with our plastic surgery teams as a collaborative group to treat our patients enrolled in this study,” explains Chiba. “We aim to do the surgery together. I perform the mastectomy, and then reconstruction with our breast reconstruction colleagues at the same setting. Patients benefit by having both disciplines working together in the operating room.” 

Co-investigators Shelley Hwang, MD, MPH, surgical oncologist, supports with robotic surgical techniques for the study, and Laura H. Rosenberger, MD, MS, surgical oncologist, also supports as a bedside surgeon for the trial. 

The study also has two dedicated research coordinators to support the clinical research team and participants.

Chiba says that positive findings from this study could open the possibility of efficacy in robotic nipple-sparing techniques to treat patients with early-stage breast cancer and those who choose to have preventive risk-reducing mastectomies. “There are future applications that could create less invasive and equally effective treatments for patients with and without a breast cancer diagnosis.” 

The study will evaluate the clinical efficacy and safety of the procedure. “We want to identify if there are any adverse effects, immediate or long-term complications, and conversion rates of planned robotic procedures that turn into open procedures,” says Chiba. “The hope is that this robotic nipple-sparing procedures are comparable to other studies on robotic surgeries in their positive benefits for healing time, cosmetic results, and patient satisfaction.”

Patient satisfaction is a key outcome of the study, as well as tracking recurrence rate and disease-free survival in the long term. “Quality and longevity of life for our patients are priorities. If this procedure can effectively eradicate cancer while helping patients maintain their healing and body image, that’s a tremendous result.”