Clinical Trial 15769

Cancer Type: Breast
Interventions:Not Applicable

Study Type: Other
Phase of Study: Pilot


    Study Title

    Prospective Nipple-Areola Skin-Sparing Mastectomy


    The purpose of this study is to see if keeping the nipple-areola disk: 1. increases the risk (greater than 1%) of the patient's cancer coming back in the local area; 2. has sensation after a mastectomy (removal of the breast) is performed; and 3. affects body image and quality of life.


    Primary Objective: - To determine the oncologic safety of performing a skin-sparing mastectomy with preservation of the NAC by determining the local recurrence rate at 2 years. Secondary Objectives: - To determine the sensation of the NAC post nipple-areola skin-sparing mastectomy. - To determine the impact of preservation of the NAC on body image and quality of life.

    Inclusion Criteria


  • All patients who will be surgically treated for breast cancer at Moffitt Cancer Center (MCC) with a nipple-areola skin-sparing mastectomy will be eligible for this study if all of the following are true:
  • The cancer is unifocal and the histology is invasive ductal, invasive lobular, or a sarcoma
  • The invasive tumor size is 3cm or smaller based on pre-operative breast imaging
  • The tumor margin is greater than 2cm from the areola edge based radially and 2cm from the posterior margin of the nipple-areola base based on pre-operative breast imaging
  • Clinically the patient is lymph node-negative and having a sentinel lymph node biopsy at the time of the mastectomy on the cancer side (not required on a prophylactic mastectomy)
  • All patients who will have a prophylactic mastectomy (unilateral or bilateral) for risk-reduction will be eligible for a nipple-areola skin-sparing mastectomy of the breast without cancer.

  • Exclusion Criteria


  • Patients under the age of 18 and patients over the age of 85 at the time of surgery.
  • Extensive Ductal Carcinoma In Situ (defined as greater than 30% of the total tumor volume)
  • Previous history of breast cancer (invasive or non-invasive)
  • Previous history of irradiation to the breast area (i.e. Mantle radiation for lymphoma)
  • Previous history of nipple-areola surgery (duct excision, circumareolar incisions)
  • The invasive cancer is greater than 3cm in size, is multicentric, is within 2cm from the areola margin or is within 2cm from the posterior aspect of the nipple-areola base
  • Clinically suspicious axillary lymph nodes on palpation or by fine needle aspiration.
  • History of smoking within 6 months of intended surgery
  • Obesity (defined as a BMI of greater than 30)
  • Not a candidate for immediate breast reconstruction
  • Not a candidate for nipple-areola SSM due to the location of the nipple being below the inframammary fold with the patient sitting, breast size is > 500 grams or significant contour abnormalities of the nipple-areola complex itself