Nipple-Areola Complex (NAC) Irradiation After Nipple-Sparing Mastectomy and Reconstruction
Status:
Recruiting
Trial end date:
0000-00-00
Target enrollment:
Participant gender:
Summary
Overall rationale: Prophylactic NAC irradiation after nipple-areola sparing mastectomy and
immediate reconstruction for patient with ductal carcinoma in-situ or invasive breast cancer
will allow better cosmesis and patient's satisfaction.
Study design: Phase I trial assessing the safety, feasibility and toxicity of prophylactic
NAC irradiation after nipple-areola sparing mastectomy and immediate reconstruction in
patients with ductal carcinoma in-situ or invasive breast cancer.
Primary objective: To determine the recommended phase I dose of post-operative prophylactic
NAC irradiation.
Secondary objectives: To provide extensive descriptive data regarding NAC-sparing surgery
with reconstruction, including both surgeon experience and patient evaluation of cosmetic
results. Survival and recurrence will be assessed.
Study size: Between 12 and 18 patients will be enrolled in this phase I study.