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MC230302

Overview

About this study

This is a prospective, phase II trial to assess feasibility of patients undergoing NSM willingness to be randomized to neurotization or not. Feasibility is to be established in preparation for a larger, multi-site randomized prospective trial aimed at determining if neurotization improves objective and subjective patient outcomes. Patients undergoing NSM through an inframammary incision with prosthetic-based reconstruction will be randomized to undergo neurotization of the NAC (intervention) or not (control).

Feasibility will be defined as the accrual of 7 patients within a year (or 14 patients within 2 years).

Hypothesis: Patients undergoing NSM will be willing to enroll in a randomized trial to determine if neurotization improves patient-reported satisfaction outcomes and improves sensation, compared with nipple sparing mastectomy without neurotization.

1. Primary Objective

To determine willingness of patients undergoing NSM to enroll in a randomized trial of NSM with or without neurotization.

2. Secondary Objectives

  1. To compare patient reported outcomes, including quality of life and breast and NAC sexual functionality, for patients undergoing NSM with or without neurotization.
  2. To compare NAC sensation at 12 months in patients undergoing NSM with or without neurotization.
  3. To determine rate of mastectomy skin flap necrosis following NSM via the SKIN score.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

* Female patients age \>= 18 undergoing NSM
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Cup size A-C
* Body mass index (BMI) =\< 34
* Ptosis grade =\< 2
* Clinical stage 0 - T2N0
* Final planned implant volume =\< 400cc
* Inframammary or lateral mammary incision

Exclusion Criteria:

* Prior history of breast cancer on side of planned NSM
* Prior breast reduction or mastopexy on side of planned NSM
* Prior periareolar incision \>= 3.1cm or \>90 degrees on side of planned NSM
* Prior breast radiation (mantle field radiation also excluded) on side of planned NSM
* Planned autologous reconstruction (immediate or delayed)
* Tumor =\< 0.5cm from NAC (including suspicious calcifications or magnetic resonance imaging (MRI) enhancement)
* Planned post mastectomy radiation (PMRT)
* Planned breast splitting incision
* Active nicotine use (within 4 weeks of surgical date)
* Pregnancy

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 8/16/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

James Jakub, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

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CLS-20556503

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