Areola Preservation in NSM With Nipple Involvement

NCT07544134 | Not Yet Recruiting DMC

• 1 other identifier: APRESERVE-2025-1471
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Background: During nipple-sparing mastectomy (a surgery that removes breast tissue but keeps the nipple and areola), doctors test the tissue behind the nipple right away. If cancer cells are found in this nipple tissue, current guidelines say the entire nipple and areola must be removed. However, research suggests that when the nipple is involved, the surrounding pigmented skin (the areola) is very rarely affected by cancer. Removing it might be unnecessary and leads to a worse cosmetic outcome, which can impact a woman's self-image and quality of life. Currently, there is no prospective study to guide whether the areola can be safely preserved in this specific situation. Purpose: This is a pilot study that aims to explore the feasibility, safety, and early outcomes of a new surgical procedure: preserving the areola and performing immediate nipple reconstruction when cancer is found in the nipple during surgery. Study Plan: This is a single-arm, single-center, prospective, exploratory study. Women with early-stage breast cancer who are scheduled for a nipple-sparing mastectomy will be invited. Only if cancer is confirmed in the nipple during their surgery will they be enrolled into the single test group. In this group: The nipple is removed. A small ring of tissue from under the areola is tested immediately (second frozen section). If this ring shows no cancer, the areola skin is preserved. A new nipple is created during the same operation using a local skin flap technique (purse-string suture). All patients will have immediate breast reconstruction. We plan to include about 40-60 patients at one hospital. Patients will be closely followed for 3 years with regular check-ups and scans to monitor for any cancer recurrence or complications. What We Will Measure (Exploratory Endpoints): Safety \& Feasibility: The success rate of areola preservation (based on negative second frozen section), surgical complication rates (e.g., infection, tissue necrosis). Early Effectiveness: The rate of cancer returning in the breast/chest wall area within 3 years (local recurrence). Patient-Reported Outcomes: Patient satisfaction with their breasts and well-being, measured by the BREAST-Q questionnaire before and after surgery. Why This Study is Important: This is the first prospective study to systematically evaluate this new surgical approach. The results will provide crucial preliminary data on safety and early outcomes. If the findings are promising, they will form the foundation for designing a larger, controlled trial in the future. Ultimately, this research could lead to a new option that offers women better cosmetic results and improved quality of life after mastectomy.

Conditions

Breast Cancer; Ductal Carcinoma In Situ, DCIS; Invasive Breast Carcinoma

Keywords

Breast Cancer; Nipple Sparing Mastectomy; NSM; Nipple Areola Complex; Nipple Reconstruction

Outcome Measures

Primary Outcomes (1)

• Local Recurrence Rate

  The incidence of local recurrence in the ipsilateral chest wall/skin or residual breast tissue, assessed by clinical examination and imaging (breast ultrasound and/or MRI), with pathological confirmation for suspected cases.

  3 years post-surgery

Secondary Outcomes (3)

• Rate of Successful Areola Preservation

  Intraoperative

• Incidence of Postoperative Complications

  Within 90 days post-surgery

• Change in Patient-Reported Satisfaction and Well-being

  Baseline, 6, 12, 24, and 36 months post-surgery

Study Arms (1)

Areola Preservation & Nipple Reconstruction Group

EXPERIMENTAL

Patients with intraoperatively confirmed nipple involvement during nipple-sparing mastectomy, who receive areola-preserving surgery (pending negative second frozen section of the peri-areolar margin) combined with immediate nipple reconstruction via a local flap technique (e.g., purse-string suture), followed by immediate breast reconstruction.

Procedure: Areola-Preserving Nipple-Sparing Mastectomy with Immediate Nipple Reconstruction

Interventions

Areola-Preserving Nipple-Sparing Mastectomy with Immediate Nipple Reconstruction PROCEDURE

This is a combined surgical procedure for patients with intraoperative nipple involvement during nipple-sparing mastectomy. After resection of the involved nipple, a full-thickness peri-areolar tissue margin is harvested for a second intraoperative frozen section. If the margin is negative for carcinoma, the areola skin is preserved. An immediate nipple reconstruction is then performed using a local skin flap technique (e.g., purse-string suture). This is followed by standard immediate breast reconstruction (implant-based or autologous).

Areola Preservation & Nipple Reconstruction Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Change in scores from baseline as measured by the BREAST-Q questionnaire (Satisfaction with Breasts, and Psychosocial, Sexual, and Physical Well-being scales).
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female, age ≥ 18 years.
• Pathologically confirmed primary invasive breast carcinoma or ductal carcinoma in situ (DCIS).
• Clinical tumor stage cTis-2, N0-2, M0 (AJCC 8th Edition).
• Planned for therapeutic nipple-sparing mastectomy (NSM) with immediate reconstruction.
• Intraoperative frozen section confirms involvement of the nipple core tissue by invasive carcinoma or DCIS.
• ECOG performance status 0-1.
• Willing and voluntarily provide written informed consent.

You may not qualify if:

• Clinical or radiological suspicion of areola or skin involvement.
• Inflammatory breast cancer.
• Pregnancy or lactation.
• Any severe medical or psychiatric condition that, in the investigator's judgment, would preclude safe participation or compliance.
• Severe uncontrolled comorbidities with a life expectancy of less than 5 years.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Study Officials

• Ke Wang, MD

  Department of Breast Surgery, The Second Affiliated Hospital of Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingxin Jiang, MD

CONTACT

+86-1356711447; blwangke@126.com

Bing Yang, MD

CONTACT

+86-18868112181; 11718405@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label surgical study where masking of the participant and surgeon is not feasible.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm, prospective, exploratory study

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: April 22, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 15, 2029
• Study Completion (Estimated): January 15, 2030
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)