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

NCT01208974 | Active Not Recruiting Results DMC FDA Device

• 2 other identifiers: 20090299SCCC-2009004
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Keywords

Breast Cancer; Nipple Area Complex; Mastectomy; Radiation Therapy; Nipple-Sparing; Breast Reconstruction

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of Prophylactic NAC Irradiation.

  The recommended Phase II dose will be reported as the MTD at which only 0 or 1 out of 6 participants experiences dose limiting toxicity (DLT). DLT will be reported as any of the following: Grade 4 skin rash or pain, NAC necrosis, any toxicity requiring interruption of NAC irradiation greater than 2 weeks or any grade 4 or 5 treatment related toxicity. Toxicity will be evaluated by treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0.

  Up to 13 weeks

Secondary Outcomes (4)

• Cosmetic Outcome

  12 months

• Disease-Free Survival Rate in Study Participants

  Up to 5 years

• Overall Survival Rate in Study Participants

  Up to 5 years

• Recurrence Rate in Study Participants

  Up to 5 years

Study Arms (1)

Phase 1 MTD NAC RT

EXPERIMENTAL

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.

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

Interventions

Nipple-Sparing Mastectomy 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.

Also known as: NAC-sparing mastectomy, Nipple and areola complex-sparing mastectomy

Phase 1 MTD NAC RT

Breast Reconstruction 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.

Phase 1 MTD NAC RT

Axillary Surgery PROCEDURE

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

Also known as: Axillary Dissection, Sentinel Node Biopsy

Phase 1 MTD NAC RT

Prophylactic Nipple-Areolar Complex RT RADIATION

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

Also known as: Prophylactic NAC Radiation Therapy

Phase 1 MTD NAC RT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Ductal

Interventions

Mastectomy, Subcutaneous; Mammaplasty; Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative; Cosmetic Techniques; Therapeutics; Plastic Surgery Procedures; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Lymph Node Excision; Investigative Techniques

Results Point of Contact

• Title: Cristiane Takita MD
• Organization: University of Miami

ctakita@med.miami.edu

305-243-4337

Study Officials

• Cristiane Takita, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical

Model Details: Phase 1 dose-escalation/de-escalation.

Study Record Dates

• First Submitted: September 22, 2010
• First Posted: September 24, 2010
• Study Start: March 16, 2010
• Primary Completion: February 13, 2018
• Study Completion (Estimated): May 31, 2026
• Last Updated: June 26, 2025
• Results First Posted: January 18, 2022

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)