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

University of Miami

Status: Active, not recruiting

Conditions: Breast Cancer; Ductal Carcinoma

Treatments: Procedure: Nipple-Sparing Mastectomy; Radiation: Prophylactic Nipple-Areolar Complex RT; Procedure: Breast Reconstruction; Procedure: Axillary Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01208974

SCCC-2009004 (Other Identifier)

20090299

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Phase 1 MTD NAC RT

Experimental group

Description:

Participants will undergo a Nipple-Areolar Complex (NAC)-sparing mastectomy with immediate reconstruction and axillary surgery, if indicated, on Week 1. Anytime between Weeks 5-8, participants will undergo a dose-escalation/de-escalation of prophylactic NAC radiation treatment (RT) twice daily (minimum of 4 hours apart) for 5 days. Dose escalation/de-escalation design are as follows: * Dose Level I - 10 fractions of 2.0 Gy for a total of 20 Gy * Dose Level II - 10 fractions of 2.5 Gy for a total of 25 Gy * Dose Level III - 10 fractions of 3.0 Gy for a total of 30 Gy * Dose Level IV - 10 fractions of 3.5 Gy for a total of 35 Gy Participants will be treated between cohorts of 2-6 patients per dose level starting at dose level II. Dose escalation stops when 2 out of 2-6 participants encounter Dose Limiting Toxicities (DLT). Standard of care chemotherapy, at treating physician's discretion, can be initiated 2 weeks after RT.

Treatment:

Procedure: Axillary Surgery

Procedure: Breast Reconstruction

Radiation: Prophylactic Nipple-Areolar Complex RT

Procedure: Nipple-Sparing Mastectomy