At a glance
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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
In Brief
A clinical study evaluating Nipple-Sparing Mastectomy, Breast Reconstruction, and 2 other interventions for Breast Cancer and Ductal Carcinoma. Active but no longer recruiting, targeting 21 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.
Axillary Dissection or Sentinel Node Biopsy (SNB) will be performed at surgeon's discretion.
Prophylactic Nipple-Areolar Complex Radiation Therapy per protocol. Administered between weeks 5 to 8.