Nipple Sparing Mastectomy With Immediate Implant-Based Reconstruction for Women With Early-Stage Breast Cancer
Clinicaltrials.gov identifier:
NCT05720039
Treatment
Nipple sparing mastectomy with reconstruction for women with early-stage breast cancer
Study Contact Information:
Sponsor contact:
Kathryn Wine, MPH, Director of Clinical Affairs, SP [email protected]
A Randomized Study of Robotic-Assisted Nipple Sparing Mastectomy vs. Standard Surgery Nipple Sparing Mastectomy for Early Stage Breast Cancer
About the Study
This study will compare robotic-assisted nipple sparing mastectomy (NSM) to standard surgery NSM for women with 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 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 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.
California
City: Duarte RECRUITING
Facility: City of Hope
Contact Info:
[email protected]
949-671-4673
[email protected]
949-671-4112
Jennifer Tseng, MD
Jamie Rand, MD
Mouchammed Agko, MD
Antoine Carre, MD
Katharine Schulz-Costello, DO
City: Los Angeles RECRUITING
Facility: Cedars-Sinai
Contact Info:
[email protected]
Farin Amersi, MD
Alice Chung, MD
Kjirsten Carlson, MD
Marissa Boyle, MD
Edward Ray, MD
Florida
City: Jacksonville RECRUITING
Facility: Mayo Clinic Florida
Contact Info:
[email protected]
904-953-4248
James Jakub, MD
Brian Rinker, MD
Sarah McLaughlin, MD
Olivia Ho, MD
Tammeza Gibson, PA
Georgia
City: Atlanta RECRUITING
Facility: Emory University
Contact Info:
[email protected]
Cathy Graham, MD
Clara Farley, MD
Sarah Apatov, PA
Peter Thompson, MD
Illinois
City: Evanston RECRUITING
Facility: Endeavor Health
Contact Info:
[email protected]
847-570-1783
[email protected]
847-570-1512
Katherine Kopkash, MD
Michigan
City: Detroit RECRUITING
Facility: Corewell
Contact Info:
[email protected]
[email protected]
Nayana Dekhne, MD
Jesse Selber, MD
Minnesota
City: Rochester RECRUITING
Facility: Mayo Clinic Rochester
Contact Info:
507-284-3975
[email protected]
507-284-4432
Mara Piltin, DO
Missouri
City: Saint Louis RECRUITING
Facility: Washington University, St. Louis
Contact Info:
[email protected]
314-747-0063
Rebecca Aft, MD
Joani Christensen, MD
North Carolina
City: Durham RECRUITING
Facility: Duke University
Contact Info:
[email protected]
[email protected]
919-681-5908
Akiko Chiba, MD
Shelley Hwang, MD
Laura Rosenberger, MD
Geoffrey Sisk, MD
Rebecca Knackstedt, MD
Maggie Dinome, MD
New York
City: Lake Success RECRUITING
Facility: Northwell Health
Contact Info:
[email protected]
516-881-7046
Alan Kadison, MD
Neil Tanna, MD
Armen Kasabian, MD
Pennsylvania
City: Philadelphia RECRUITING
Facility: University of Pennsylvania
Contact Info:
[email protected]
Ari Brooks, MD
Texas
City: Houston RECRUITING
Facility: MD Anderson Cancer Center
Contact Info:
[email protected]
713-745-3759
Rosa Hwang, MD
Solange Cox, MD
Renee Largo, MD
Joani Christensen, MD
John Shuck, MD
Washington
City: Seattle RECRUITING
Facility: University of Washington
Contact Info:
[email protected]
[email protected]
Sara Javid, MD
Meghan Flanagan, MD
Suzanne Marie Inchauste, MD
Wisconsin
City: Milwaukee RECRUITING
Facility: Ascension St. Columbia Mary's
Contact Info:
[email protected]
Alysandra Lal, MD
John Yousif, MD
- Female, age 21 or older
- Body mass index less than 30
- Candidate for nipple sparing mastectomy in one or both breasts with planned immediate reconstruction with implants
- Diagnosis of early breast cancer
- Breast cup size C or smaller
- Previous breast surgery
- Diagnosis of breast cancer
- Previvors or people without a breast cancer diagnosis
- Prior radiation treatment to the chest
- Currently smoking
- Pregnant or actively breastfeeding