Clinical trial · Observational
A Pilot Study to Evaluate Nipple-Areolar Complex (NAC) Sparing Mastectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NAC Sparing Mastectomy | Procedure | — | UNRESOLVED |
| Questionnaire | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- NAC Sparing Mastectomy
- description
- A skin-sparing mastectomy performed with preservation of the nipple-areolar complex (NAC). Questionnaires taking about 20-30 minutes to complete.
- interventionNames
- Procedure: NAC Sparing Mastectomy
- Behavioral: Questionnaire
Primary outcomes (1)
- measure
- Nipple Sensation Evaluation (following NAC sparing mastectomy)
- timeFrame
- Within first month postoperatively, then at 3 months, 6 month, 1 year, 2 years, and 5 years postoperatively (each interval +/- 1 month)
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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 performed 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 mastectomy 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
References
Publications (0)
Data not yet available