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

Completed

Conditions studied: Breast Cancer

In brief

The goal of this study is to study nipple-areolar complex (NAC) sparing mastectomy as an alternative procedure to the standard skin-sparing mastectomy for women who have breast cancer or are at high-risk for developing breast cancer. You have been asked to take part in this study because your treating surgeon feels you are a candidate for skin-sparing mastectomy and because you want breast reconstruction after surgery. Outcomes that will be measured include how much nipple sensation can be kept after surgery; how satisfied you are with how the breast looks after surgery; complication rates; and your quality-of-life.

Key facts

Study ID

NCT00539227

Run by

M.D. Anderson Cancer Center

People needed

37

Starts

2007-10-01

Expected to finish

2013-07-01

Last updated by the study team

2013-08-26

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients desiring prophylactic mastectomy with immediate reconstruction
• Patients with Stage 0, I, or II breast cancer who are candidates for and desire skin-sparing mastectomy with immediate reconstruction
• Tumor location greater than or equal to 2.5 cm from the border of the NAC based on preoperative imaging and/or clinical exam
• Patients must sign an informed consent and be registered before the procedure is performed

You may not qualify if…

• Patients with cancer involvement of the NAC on clinical exam, defined as induration, retraction, fixation, ulceration, or pathologic nipple discharge
• Patients with subareolar tumor locations, tumors located < 2.5 cm from the border of the NAC
• Patients with Paget's disease of the nipple
• Patients who have locally advanced breast cancer manifesting as inflammatory breast cancer or gross involvement of the mastectomy skin
• Patients with history of prior surgery involving a periareolar incision
• Patients desiring a concomitant ipsilateral reduction mammoplasty at time of mastectomy
• Patients with macromastia as defined by the plastic surgeon
• Patients with a body mass index (BMI) greater than 40 kg/m2
• Patients who actively smoke
• Patients with known collagen vascular disease
• Patients with prior ipsilateral chest wall irradiation less than 12 months from their time of surgery

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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