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A Pilot Study to Evaluate Nipple-Areolar Complex (NAC) Sparing Mastectomy

Open (Enrolling)
Breast Cancer

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Trial Information

A Pilot Study to Evaluate Nipple-Areolar Complex (NAC) Sparing Mastectomy

Operative Procedure:

You will have a skin-sparing mastectomy performed with preservation of the NAC. During
surgery, the tissue will be tested while you are still under general anesthesia.

The NAC may be removed completely during the surgery if malignant cells are found during the
testing done during the surgery or if suspicious cells that are not clearly benign cells are
found. This will be up to your doctor. The NAC may also be removed surgically if the
primary tumor is found to be located less than an inch from the border of the NAC, or you
are found to have breast cancer with multiple "center" sites. The nipple can also be
removed by itself, with the areola spared (this is called "areolar-sparing mastectomy") if
your doctor is worried about its blood supply. These decisions will be made by your
pathologist and treating surgeon.

You will then undergo immediate reconstruction, with either your own tissue, prosthetic
tissue, or a combination of the two. This is up to your plastic surgeon. You will have met
with your plastic surgeon before surgery to discuss the best reconstructive method for you,
and you will be given an informed consent to sign at that time with details about the method
you decide to use.

The breast tissue under the NAC will be biopsied and tested after your surgery. After that
tissue has been tested, a second surgery may be needed if cancer cells are found, the tumor
is too close to the NAC, or it has more than 1 "center" site. You will have the whole NAC
removed in a separate operation. The place where the NAC was removed will be repaired by a
plastic surgeon, who will choose the best method to get an acceptable cosmetic result.
This may involve one or more extra surgeries, and you will be given separate informed
consent documents to sign for each surgery.

Follow-up and Questionnaires:

If you agree to take part in this study, 4 sensory tests will be conducted on both breasts
using a variety of hand-held devices. These tests are painless and will be performed at
regularly scheduled follow-up visits in clinic. They will measure nipple and areolar
sensitivity, as well as nipple erectibility. The tests will involve the placement of fibers
of various thicknesses and blunt metal probes on the skin of your nipple and areola. All
tests will be performed once before the surgery and then at about 3 months, 6 months, and 1
year after surgery, at your follow-up clinic visits.

Your breasts will be photographed at your 6-month and 1-year follow-up visits after surgery.
At these visits, you will look at those photographs to decide how satisfied you are with
how the breasts look. Two (2) plastic surgeons not directly involved in your surgery will
also study those photographs by themselves and fill out a similar questionnaire rating their
impression of the results of your plastic surgery. These results will not be made available
to you. You will also complete 2 quality-of-life questionnaires within 1 month of your
surgery, and then at 3 months, 6 months, 1 year, 2 years, and 5 years after surgery (+/- 1
month). The questionnaires will ask questions about nipple sensation, cosmetic outcomes,
complications, and your quality of life. The questionnaires will take about 30 minutes to

Length of Study:

You will remain on study for up to 5 years.

This is an investigational study. Up to 37 patients will take part in this study. All will
be enrolled at MD Anderson.

Inclusion Criteria:

1. Patients desiring prophylactic mastectomy with immediate reconstruction

2. Patients with Stage 0, I, or II breast cancer who are candidates for and desire
skin-sparing mastectomy with immediate reconstruction

3. Tumor location greater than or equal to 2.5 cm from the border of the NAC based on
preoperative imaging and/or clinical exam

4. Patients must sign an informed consent and be registered before the procedure is

Exclusion Criteria:

1. Patients with cancer involvement of the NAC on clinical exam, defined as induration,
retraction, fixation, ulceration, or pathologic nipple discharge

2. Patients with subareolar tumor locations, tumors located < 2.5 cm from the border of
the NAC

3. Patients with Paget's disease of the nipple

4. Patients who have locally advanced breast cancer manifesting as inflammatory breast
cancer or gross involvement of the mastectomy skin

5. Patients with history of prior surgery involving a periareolar incision

6. Patients desiring a concomitant ipsilateral reduction mammoplasty at time of

7. Patients with macromastia as defined by the plastic surgeon

8. Patients with a body mass index (BMI) greater than 40 kg/m2

9. Patients who actively smoke

10. Patients with known collagen vascular disease

11. Patients with prior ipsilateral chest wall irradiation less than 12 months from their
time of surgery

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Nipple Sensation Evaluation (following NAC sparing mastectomy)

Outcome Time Frame:

Within first month postoperatively, then at 3 months, 6 month, 1 year, 2 years, and 5 years postoperatively (each interval +/- 1 month)

Safety Issue:


Principal Investigator

Gildy V. Babiera, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

October 2007

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Nipple-Areolar Complex
  • Mastectomy
  • Prophylactic mastectomy
  • Immediate reconstruction
  • Reconstructive surgery
  • Questionnaire
  • Survey
  • NAC
  • Breast Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030