‘Groundbreaking’ trial to assess robotic-assisted, single-port mastectomy for breast cancer
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City of Hope has opened a multicenter randomized trial to assess the safety and effectiveness of robotic-assisted, single-incision mastectomy for patients with early breast cancer.
The trial will compare da Vinci SP (Intuitive) — a single-port robotic surgical system cleared in the United States for urology and transoral otolaryngology procedures — with traditional open nipple-sparing mastectomy.
Jennifer Tseng, MD, medical director of breast surgery at City of Hope Orange County and the trial’s principal investigator, said she considers the trial “groundbreaking.”
“We hope this will lead to significant improvements for breast surgery,” Tseng told Healio.
The minimally invasive approach leaves a small hidden scar on the side of the body. The benefits of this approach may include reduced rates of skin and nipple necrosis, as well as faster recovery time, Tseng said.
Robotic single-port mastectomy is commonly performed in Europe and Asia, but the technique has not yet been offered to patients in the United States.
“This trial has opened in conjunction with FDA oversight to study it in the U.S., so hopefully we can offer it more widely,” Tseng said.
The trial — the first of its kind in the U.S. — likely will remain open for 2 to 3 years at 15 centers. Enrollment is underway.
The trial is open to women aged 21 years or older with early-stage breast cancer, BMI less than 30, breast ptosis of grade 2 or lower, and cup size of C or smaller.
For more information about the trial, email Stephanie Casal, MN, RN, CNS, at scasal@coh.org or call (949) 886-2729.
If your institution is launching an oncology or hematology clinical trial and you would like to inform our clinical audience about the study design and patient enrollment opportunities, email us at hematology-oncology@healio.com.
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