A Randomized Study of Robotic-Assisted Nipple Sparing Mastectomy vs. Standard Surgery Nipple Sparing Mastectomy for Early Stage Breast Cancer

Clinicaltrials.gov identifier:
NCT05720039 (https://clinicaltrials.gov/show/NCT05720039)

Treatment
Nipple sparing mastectomy with reconstruction for women with early-stage breast cancer

Sponsor contact:
Kathryn Wine, MPH, Director of Clinical Affairs, SP [email protected]

About the Study

This study will compare robotic-assisted nipple sparing mastectomy (NSM) to standard surgery NSM for women with early-stage breast cancer. Eligible women will be randomly placed into one of two groups and either undergo the robotic-assisted procedure or undergo the standard of care open surgery for NSM. Participants will be followed for 5 years.

What the Study Involves

This study is enrolling women with early-stage breast cancer who are appropriate for nipple sparing mastectomy followed by immediate implant-based reconstruction. Interested participants will be screened to see if you are a candidate. Typically, your evaluation would include being seen by both a breast surgeon as well as a plastic surgeon. If you want to be included in the study and you meet all criteria to be enrolled, you will be randomized to the procedure type. If you want to be enrolled, you indicate this by signing a study-specific consent form. The consent process is educational and goes over all the risks and benefits of participation, the requirements and expectations of the study, background on both procedure types, and costs to you as a participant. You would have time to get any questions answered by the study team in advance of signing. Your participation is voluntary. If selected for the study, you will either have a nipple sparing mastectomy procedure that is open surgery, which is a procedure performed via an incision on the breast or robotic-assisted surgery, which aims to perform this operation with an incision under the arm pit in a minimally invasive manner. In either case, the nipple sparing mastectomy will be immediately followed by implant-based breast reconstruction. Being in the study requires follow up visits on a specific schedule. You will have study follow up after your surgery at 2 weeks, 6 weeks, 6 months, and then annual at years 1-5. The follow up visits are intended to collect data on safety and effectiveness of your NSM procedure and can include standard medical evaluation in addition to collecting your feedback about your procedure in the form of questionnaires. For this study, your medical care is billed the same on study as it would be if you were having NSM outside of the study. Your study center may offer a stipend for research visits.

Study Sites

California

Duarte and Orange County
City of Hope (Dr. Jennifer Tseng, Dr. Jaime Rand, Dr. Mouchammed Agko, Dr. Katharine Schulz-Costello, Dr. Antoine Carre)
Contact: Dr. Jennifer Tseng 949-671-4673 or Stephanie Casal 949-671-4112

Florida

Jacksonville
Mayo clinic (Dr. James Jakub, Dr. Brian Rinker, Dr. Sarah McLaughlin, Dr. Olivia Ho, Tammeza Gibson, PA)
Contact: Dr. Mara Piltin 507-284-3975 or Clinical Coordinators 507-284-4432

Illinois

Evanston
NorthShore (Dr. Katherine Kopkash)
Contact: Anne Jankowski 847-570-1512

Minnesota

Rochester
Mayo clinic (Dr. Mara Piltin, Dr. Jeffrey Johnson, Dr. Aparna Vikayasekaran, Dr. Amela Dudakovic, Dr. Jorys Martinez-Jorge, Dr. Judy Boughey, Annika Balekos, PA)
Contact: Dr. Mara Piltin 507-284-3975 Clinical Coordinators 507-284-4432

Missouri

St. Louis
Washington University St. Louis (Dr. Rebecca Aft, Dr. Rachel Anolik, Dr. Joani Christensen)
Contact: Dr. Rebecca Aft 314-747-0063

New York

Lake Success
Northwell Health (Dr. Alan Kadison, Dr. Gary Deutsche, Dr. Neil Tanna, Dr. Armen Kasabian)
Contact: Sabah Iqbal [email protected]

North Carolina

Durham
Duke University Health (Dr. Akiko Chiba, Dr. Shelley Hwang, Dr. Laura Rosenberger, Dr. Geoffrey Sisk, Dr. Rebecca Knackstadt, Dr. Maggie Dinome
Contact: Kimberly Turnage [email protected] or Adi Molvin [email protected]

Pennsylvania

Philadelphia
University of Pennsylvania (Dr. Ari Brooks, Dr. Leisha Elmore, Dr. Kanchwala, Dr. Azoury)
Contact: Juliana Ruiz [email protected]

Texas

Houston
MD Anderson (Dr. Rosa Hwang, Dr. Solange Cox, Dr. Shuck, Dr. Largo, Dr. Christensen)
Contact: John Tran 713-745-3759

This Study is Open To:

This Study is Not Open To:

About FORCE

FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.