Status:
RECRUITING
Neurotization of the Nipple Areolar Complex to Restore Sensation for Patients With Breast Cancer Undergoing Nipple Sparing Mastectomy and Reconstruction
Lead Sponsor:
Mayo Clinic
Conditions:
Anatomic Stage 0 Breast Cancer AJCC v8
Anatomic Stage I Breast Cancer AJCC v8
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial tests the willingness of patients undergoing nipple sparing mastectomy (NSM) to enroll in a randomized study of NSM with or without neurotization of the nipple areolar complex (NAC...
Detailed Description
PRIMARY OBJECTIVE: I. To determine willingness of patients undergoing NSM to enroll in a randomized trial of NSM with or without neurotization. SECONDARY OBJECTIVES: I. To compare patient reported ...
Eligibility Criteria
Inclusion
- Female patients age \>= 18
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Planned nipple sparing mastectomy (NSM)
- Ideal NSM candidates would meet the following criteria:
- Cup size A-C
- BMI \<34
- Ptosis grade \< 2
- Clinical stage 0 - T2N0
- Final planned implant volume \< 400cc
- Inframammary or lateral mammary incision
- Tumor \> 0.5cm from the nipple areolar complex (NAC)
- No prior breast reduction, mastopexy, or periareolar incisions on side of planned NSM
- No prior breast radiation on side of planned NSM
- Tumor \<0.5cm from NAC (including suspicious calcifications or MRI enhancement)
- No planned post mastectomy radiation (PMRT)
- No nicotine use within 4 weeks of surgical date
Exclusion
- Planned autologous reconstruction (immediate or delayed)
- Pregnancy
Key Trial Info
Start Date :
December 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 10 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06153836
Start Date
December 5 2023
End Date
November 10 2026
Last Update
December 4 2025
Active Locations (1)
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1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980