NCT01208974

Nipple-Areola Complex (NAC) Irradiation After Nipple-Sparing Mastectomy and Reconstruction

A Phase I Trial Assessing the Safety and Feasibility of Prophylactic Nipple-Areola Complex (NAC) Irradiation After Nipple-Sparing Mastectomy and Immediate Reconstruction in Patients With In-Situ or Invasive Breast Cancer

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to see if a participant's nipple and areola can be safely preserved by adding radiation to these areas after a nipple-sparing mastectomy and immediate breast reconstruction.

Conditions

• Breast Cancer
• Ductal Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Nipple-Sparing Mastectomy	Subcutaneous Mastectomy (SCM) to be performed, preserving the nipple and areola complex, after a frozen section of the tissue underneath the nipple-areola complex is sampled and found to be negative for tumor. Performed during Week 1.
PROCEDURE	Breast Reconstruction	Immediate reconstruction of the breast will be performed (after Nipple-Sparing Mastectomy) by the plastic surgeon, type depend on surgeon's discretion and patient's desire. Performed during Week 1.
PROCEDURE	Axillary Surgery	Axillary Dissection or Sentinel Node Biopsy (SNB) will be performed at surgeon's discretion.
RADIATION	Prophylactic Nipple-Areolar Complex RT	Prophylactic Nipple-Areolar Complex Radiation Therapy per protocol. Administered between weeks 5 to 8.

Timeline

• Start date: 2010-03-16
• Primary completion: 2018-02-13
• Completion: 2026-05-31
• First posted: 2010-09-24
• Last updated: 2025-06-26
• Results posted: 2022-01-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study