Recruiting
Phase 2

Neurotization

Sponsor:

Mayo Clinic

Code:

NCT06153836

Conditions

Anatomic Stage 0 Breast Cancer AJCC v8

Anatomic Stage I Breast Cancer AJCC v8

Anatomic Stage IIA Breast Cancer AJCC v8

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Neurotization Procedure

Questionnaire Administration

Subcutaneous Mastectomy

Study Details

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 0 Breast Cancer AJCC v8

Anatomic Stage I Breast Cancer AJCC v8

Anatomic Stage IIA Breast Cancer AJCC v8

Study ID

NCT06153836

Start date

Dec 5, 2023

Status verified date

Aug, 2026

Completion date

Nov 10, 2026

Anticipated

Primary completion date

Nov 10, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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)
  • No nicotine use within 4 weeks of surgical date

Exclusion Criteria:

  • Planned autologous reconstruction (immediate or delayed)
  • Pregnancy

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: ARM I (control)

Patients undergo standard of care NSM on study.

experimental: ARM II (neurotization)

Patients undergo neurotization during standard of care NSM on study.

Interventions

Neurotization Procedure

Undergo placement of nerve graft

Questionnaire Administration

Ancillary studies

Subcutaneous Mastectomy

Undergo standard of care NSM

Primary outcome measure

  • Percentage of patients undergoing nipple sparing mastectomy (NSM) to enroll in a randomized trial of NSM with or without neurotization [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224-9980

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

James W. Jakub, M.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-19.