Neurotization of the Nipple Areolar Complex to Restore Sensation for Patients With Breast Cancer Undergoing Nipple Sparing Mastectomy and Reconstruction

NCT06153836 | Recruiting Phase 2

• 3 other identifiers: MC230302NCI-2023-0957423-004411
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial tests the willingness of patients undergoing nipple sparing mastectomy (NSM) to enroll in a randomized study of NSM with or without neurotization of the nipple areolar complex (NAC). This trial also compares patient reported outcomes, including quality of life and breast and NAC sexual functionality, for patients undergoing NSM with or without neurotization of the NAC. NSM is a standard practice option for patients undergoing preventative mastectomy, but many report dissatisfaction with decreased nipple sensation. Neurotization is a surgical technique using a nerve graft in an attempt to restore NAC sensation. Neurotization during NSM and reconstruction may restore NAC sensation and improve quality of life in breast cancer patients.

Conditions

Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Anatomic Stage 0 Breast Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• Percentage of patients undergoing nipple sparing mastectomy (NSM) to enroll in a randomized trial of NSM with or without neurotization

  Will calculate the proportion of eligible patients who opt to take part in the study. Additionally, will descriptively analyze and report the specific factors that influenced patients' decisions to participate, with the aim of identifying and addressing any obstacles encountered.

  Up to 2 years

Secondary Outcomes (8)

• Chest physical well-being

  At baseline and up to 12 months

• Psychosocial well-being

  At baseline and up to 12 months

• Sexual well-being

  At baseline and up to 12 months

• Patient reported amount of sensation in nipple areolar complex (NAC) and breast

  At baseline and up to 12 months

• Patient reported significance of breast or NAC for sexuality

  At baseline and up to 12 months

Study Arms (2)

ARM I (control)

ACTIVE COMPARATOR

Patients undergo standard of care NSM on study.

Other: Questionnaire Administration; Procedure: Subcutaneous Mastectomy

ARM II (neurotization)

EXPERIMENTAL

Patients undergo neurotization during standard of care NSM on study.

Procedure: Neurotization Procedure; Other: Questionnaire Administration; Procedure: Subcutaneous Mastectomy

Interventions

Subcutaneous Mastectomy PROCEDURE

Undergo standard of care NSM

Also known as: Nipple-Sparing Mastectomy

ARM I (control); ARM II (neurotization)

Neurotization Procedure PROCEDURE

Undergo placement of nerve graft

Also known as: Nerve Regeneration Procedure

ARM II (neurotization)

Questionnaire Administration OTHER

Ancillary studies

ARM I (control); ARM II (neurotization)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients age \>= 18
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• Planned nipple sparing mastectomy (NSM)
• Ideal NSM candidates would meet the following criteria:
• Cup size A-C
• BMI \<34
• Ptosis grade \< 2
• Clinical stage 0 - T2N0
• Final planned implant volume \< 400cc
• Inframammary or lateral mammary incision
• Tumor \> 0.5cm from the nipple areolar complex (NAC)
• No prior breast reduction, mastopexy, or periareolar incisions on side of planned NSM
• No prior breast radiation on side of planned NSM
• Tumor \<0.5cm from NAC (including suspicious calcifications or MRI enhancement)
• No planned post mastectomy radiation (PMRT)

You may not qualify if:

• Planned autologous reconstruction (immediate or delayed)
• Pregnancy

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Carcinoma In Situ

Interventions

Mastectomy, Subcutaneous

Condition Hierarchy (Ancestors)

Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative

Study Officials

• James W. Jakub, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Olivia S. Ho, M.D., M.S.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 1, 2023
• Study Start: December 5, 2023
• Primary Completion (Estimated): November 10, 2026
• Study Completion (Estimated): November 10, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-12

Locations

US (1)