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

NAActive, not recruitingINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

March 16, 2010

Primary Completion Date

February 13, 2018

Study Completion Date

May 31, 2026

Conditions
Breast CancerDuctal Carcinoma
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.

Trial Locations (1)

33136

University of Miami Sylvester Comprehensive Cancer Center, Miami

All Listed Sponsors
lead

University of Miami

OTHER