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ACTIVE NOT RECRUITING
NCT01208974
NA

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

Sponsor: University of Miami

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

21

Start Date

2010-03-16

Completion Date

2026-05-31

Last Updated

2025-06-26

Healthy Volunteers

No

Interventions

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.

Locations (1)

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, United States