The principal investigator calls it “a very exciting trial … which could really change the way we do breast cancer surgery in the future.”
Endeavor Health (Evanston Hospital’s parent firm, formerly called NorthShore University HealthSystem) says the trials will “evaluate robotic-assisted, single-incision surgery for nipple-sparing mastectomies with immediate [breast] reconstruction.”
Endeavor is now looking for potential local participants for this ground-breaking study.
Dr. Katherine Kopkash, Endeavor’s Director of Oncoplastic Breast Surgery and lead local investigator, tells Evanston Now that there are two key outcomes to be checked.
First, of course, is the medical outcome … is the cancer eradicated?
But also, how effective is the “nipple sparing” by using robotics, instead of the current nipple sparing manual surgery?
“Does robotic surgery,” Kopkash says, “help improve sensation?”
Women, she explains, “are happier post-cancer surgery if they are able to keep the nipple.”
Being able to do so improves the patient’s “self-confidence and self-image,” the doctor notes.
According to Endeavor, robotic-assisted, single-incision surgery “could result in less post-operative pain, earlier return to normal daily activities, minimal scarring and increased skin preservation with improved sensitivity.”
Kopkash says robotic-assisted breast cancer surgery has been used in Europe and Asia for several years, but not yet in the United States due to the extensive testing required by the FDA.
It is used n the U.S. in many other surgeries, such as prostate cancer.
“Robotic surgery has become the norm in some [medical] areas,” she says, “but not breast cancer.”
In 2020, Kopkash was involved in a different breast cancer/robotic surgery study, but that one involved women who did not have cancer at the time, but rather had a prophylactic mastectomy (preventative removal of breast tissue) because they had the BRCA genetic mutation.
Having that mutation does not automatically mean the person will get breast cancer in her lifetime, but makes it more likely.
This new study involves women who have already been diagnosed with early-stage breast cancer.
The particular type of robot used in the trial has not yet been approved by the government for general public usage, which is why the tests are needed.
It’s a “randomized trial,” Kopkash explains.
Some participants will end up with robotic-assisted surgery, others will receive a manual procedure. But the patients will find out immediately after admission to the trials which type of nipple-sparing surgery they will get.
“Ethically, the patient should know,” in advance, Kopkash says, and not have to wait until after the surgery has been completed.
Evanston/Endeavor is the only hospital in Illinois to take part in this study, which also includes the M.D. Anderson Cancer Center in Texas, and the Mayo Clinic.
Each hospital is looking for about 10-20 participants.
To find out more, go to clinicaltrials.gov.
Breast cancer, Kopkash says, is “very treatable in its early stages.”
The hope is that these clinical trials will make the outcomes even better.