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

NCT ID: NCT01208974

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-16
• Study Completion Date: 2026-05-31

Brief 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.

Conditions

Breast Cancer; Ductal Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1 MTD NAC RT

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.

Group Type: EXPERIMENTAL

Nipple-Sparing Mastectomy

Intervention Type: PROCEDURE

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.

Breast Reconstruction

Intervention Type: PROCEDURE

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 Surgery

Intervention Type: PROCEDURE

Axillary Dissection or Sentinel Node Biopsy (SNB) will be performed at surgeon's discretion.

Prophylactic Nipple-Areolar Complex RT

Intervention Type: RADIATION

Prophylactic Nipple-Areolar Complex Radiation Therapy per protocol. Administered between weeks 5 to 8.

Interventions

Nipple-Sparing Mastectomy

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.

Intervention Type: PROCEDURE

Breast Reconstruction

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.

Intervention Type: PROCEDURE

Axillary Surgery

Axillary Dissection or Sentinel Node Biopsy (SNB) will be performed at surgeon's discretion.

Intervention Type: PROCEDURE

Prophylactic Nipple-Areolar Complex RT

Prophylactic Nipple-Areolar Complex Radiation Therapy per protocol. Administered between weeks 5 to 8.

Intervention Type: RADIATION

Other Intervention Names

NAC-sparing mastectomy; Nipple and areola complex-sparing mastectomy; Axillary Dissection; Sentinel Node Biopsy; Prophylactic NAC Radiation Therapy

Eligibility 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.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Cristiane Takita

Professor of Clinical

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cristiane Takita, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SCCC-2009004

Identifier Type: OTHER

Identifier Source: secondary_id

20090299

Identifier Type: -

Identifier Source: org_study_id