A groundbreaking multicenter randomized trial has been launched by City of Hope to evaluate the safety and effectiveness of robotic-assisted, single-incision mastectomy for patients with early breast cancer. The trial aims to compare da Vinci SP, a single-port robotic surgical system, with traditional open nipple-sparing mastectomy.

Dr. Jennifer Tseng, the medical director of breast surgery at City of Hope Orange County and the principal investigator of the trial, expressed optimism about the potential impact of this study. Although robotic single-port mastectomy is already performed in Europe and Asia, it has yet to be offered to patients in the United States. The trial, conducted under FDA oversight, aims to pave the way for wider availability of this technique.

The minimally invasive approach of single-incision mastectomy leaves a small hidden scar on the side of the body. The potential advantages of this approach include lower rates of skin and nipple necrosis, as well as a faster recovery time.

Enrollment for the trial is currently ongoing and is open to women aged 21 years or older with early-stage breast cancer, a BMI of less than 30, breast ptosis of grade 2 or lower, and a cup size of C or smaller.

This pioneering study, expected to remain open for 2 to 3 years at 15 research centers, holds promise for advancing breast surgery and improving patient outcomes. For more information about the trial and enrollment opportunities, interested individuals can email Stephanie Casal, MN, RN, CNS, at [email protected] or call (949) 886-2729.

FAQ:

Q: What is the purpose of the multicenter randomized trial conducted by City of Hope?
A: The trial aims to assess the safety and effectiveness of robotic-assisted, single-incision mastectomy for early breast cancer patients.

Q: What are the potential benefits of single-incision mastectomy?
A: The benefits of this approach may include reduced rates of skin and nipple necrosis and faster recovery time.

Q: Who is eligible for enrollment in the trial?
A: Women aged 21 years or older with early-stage breast cancer, a BMI less than 30, breast ptosis of grade 2 or lower, and a cup size of C or smaller can participate in the trial.

Q: How long will the trial be open and where will it be conducted?
A: The trial is expected to remain open for 2 to 3 years at 15 research centers.

Q: How can interested individuals obtain more information about the trial?
A: For more information, interested individuals can email Stephanie Casal, MN, RN, CNS, at [email protected] or call (949) 886-2729.