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NCT Number: NCT01208974

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: NAC-sparing mastectomy, Nipple and areola complex-sparing mastectomy

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.

Axillary Surgery

Procedure

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

Other names: Axillary Dissection, Sentinel Node Biopsy

Prophylactic Nipple-Areolar Complex RT

Radiation

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

Other names: Prophylactic NAC Radiation Therapy

Primary outcomes

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

    Time frame: Up to 13 weeks

    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.

Secondary outcomes

  1. Cosmetic Outcome

    Time frame: 12 months

    Cosmetic Outcome will be reported as the number of participants in each of the 4 cosmetic outcome category ordinal scale. The 4 cosmetic outcome category scales are excellent, good, fair and poor. Both physician and patient's evaluation will be reported.

  2. Disease-Free Survival Rate in Study Participants

    Time frame: Up to 5 years

    Disease-free survival rate in study participants will be assessed. Disease-free survival is defined from the date of surgery until the date of documented recurrence (local or distant) or breast cancer-related death, whichever occurs first. Patients who die without documentation of recurrence will be considered to have had disease recurrence at the time of death, unless there is documented evidence that no recurrence occurred before death.

  3. Overall Survival Rate in Study Participants

    Time frame: Up to 5 years

    Overall Survival rate in study participants will be assessed. Overall survival is the defined from the date of surgery until the date of death due to any cause. In the absence of death, follow-up time will be censored by the date of last contact..

  4. Recurrence Rate in Study Participants

    Time frame: Up to 5 years

    Rate of disease recurrence in study participants. The definition of local recurrence is histologic evidence of recurrent carcinoma, either invasive or non-invasive in the nipple-areola complex in the ipsilateral breast. Clinical evidence of carcinoma by physical exam and/or mammograms/MRI will not be evidence of local recurrence until biopsy proof.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2018
Study completion
2026
First posted
Sep 24, 2010
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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