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

• Status: Recruiting
• Trial end date: 0000-00-00
• Target enrollment: 18
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Miami
• Last Updated: 2016-08-26

Criteria

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.

• 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.