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

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.

Inclusion Criteria:

• Patients must have histologically confirmed in-situ or invasive breast carcinoma.
• Tis, T1, T2 invasive or non-invasive carcinoma of the breast; lesion less than 4 cm.
• Unifocal, multifocal or multicentric breast cancers that can be removed by nipple sparing mastectomy with negative surgical margins.
• No extensive intraductal component or patient with distant metastases.
• Patients must be > 18 years of age.
• No concomitant or history of nipple discharge or skin involvement.
• No prior history of malignancy (less than 5 years prior to study entry), except non-melanomatous skin cancer.
• No prior history of radiation to the chest.
• No collagenous disease (systemic lupus erythematosis, scleroderma, dermatomyositis)No previous non-hormonal therapy including radiation or chemotherapy for current breast cancer.
• No patients with Paget's disease of the nipple.
• No patients with co-existing medical conditions with life expectancy < 2 years.
• No pregnant or lactating women.
• Eastern Cooperative Oncology Group (ECOG) 0 - 2.
• Signed study-specific informed consent form prior to the study entry.

Exclusion Criteria:

• Retroareolar breast cancer lesions within one cm, depth from the skin surface.
• Concomitant or history of nipple discharge or skin involvement.
• Patient with distant metastases.
• Patient with extensive intraductal carcinoma.
• Any previously irradiated ipsilateral breast cancer.
• Patients with Paget's disease of the nipple.
• Patients with collagenous diseases, as systemic lupus erythematosis, scleroderma or dermatomyositis.
• Other malignancy, except nonmelanomatous skin cancer, less than 5 years prior to participation in this study.
• Patients who are pregnant or lactating due to potential exposure of the fetus to RT and unknown effects of RT to lactating females.
• Positive surgical margins following nipple sparing mastectomy.