Anatomic Stage 0 Breast Cancer AJCC v8Phase 2NCT06153836
Neurotization of the Nipple Areolar Complex to Restore Sensation for Patients With Breast Cancer Undergoing Nipple Sparing Mastectomy and Reconstruction
A Phase 2 study testing Neurotization Procedure, Questionnaire Administration and Subcutaneous Mastectomy in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, run by Mayo Clinic at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8
- What is being tested?
- Neurotization Procedure, Questionnaire Administration and Subcutaneous Mastectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2023to 19 Jul 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- Planned autologous reconstruction (immediate or delayed)
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
James W. Jakub, M.D.
About this study
Official title: Randomized Feasibility Study to Determine the Feasibility of Neurotization of the Nipple Areolar Complex at the Time of Nipple Sparing Mastectomy and Prosthetic Based Reconstruction
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine willingness of patients undergoing NSM to enroll in a randomized trial of NSM with or without neurotization.
SECONDARY OBJECTIVES:
- To compare patient reported outcomes, including quality of life and breast and NAC sexual functionality, for patients undergoing NSM with or without neurotization.
II. To compare NAC sensation at 12 months in patients undergoing NSM with or without neurotization.
III To determine rate of mastectomy skin flap necrosis following NSM via the skin ischemia and necrosis (SKIN) score.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo standard of care NSM on study.
ARM II: Patients undergo neurotization during standard of care NSM on study.
After completion of study intervention, patients are followed at 14 days and at 6, 12 and 24 months postoperatively.
- Conditions
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8
- Being tested
- Neurotization Procedure, Questionnaire Administration, Subcutaneous Mastectomy
- Medical subject headings
- Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurotization ProcedureProcedure or surgery
Also called Nerve Regeneration Procedure
Undergo placement of nerve graft
Questionnaire AdministrationOther
Ancillary studies
Subcutaneous MastectomyProcedure or surgery
Also called Nipple-Sparing Mastectomy
Undergo standard of care NSM
| Study group | Role | What they receive |
|---|---|---|
| ARM I (control) | Active comparator | Patients undergo standard of care NSM on study. Receives: Other: Questionnaire Administration; Procedure: Subcutaneous Mastectomy |
| ARM II (neurotization) | Experimental | Patients undergo neurotization during standard of care NSM on study. Receives: Procedure: Neurotization Procedure; Other: Questionnaire Administration; Procedure: Subcutaneous Mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years
Secondary outcomes (8)
Chest physical well-being
Measured using the BREAST-Q© scored on a 3-point Likert scale where 1=None of the time and 3=All of the time. Higher scores indicate poorer chest physical well-being.
Measured: At baseline and up to 12 months
Psychosocial well-being
Measured using the BREAST-Q© scored on a 5-point Likert scale where 1=None of the time and 5=All of the time. Higher scores indicate poorer psychosocial well-being.
Measured: At baseline and up to 12 months
Sexual well-being
Measured using the BREAST-Q© scored on a 5-point Likert scale where 1=None of the time and 5=All of the time. Higher scores indicate poorer sexual well-being.
Measured: At baseline and up to 12 months
Patient reported amount of sensation in nipple areolar complex (NAC) and breast
Patient reported amount of sensation in nipple areolar complex (NAC) and breast will be will be assessed using a 5-item sensation questionnaire with 5 options to answer each question. Examples of answers include a range from Very unpleasant to Very pleasant or Unimportant to Very Important. Results will be reported descriptively.
Measured: At baseline and up to 12 months
Patient reported significance of breast or NAC for sexuality
Patient reported significance of breast or NAC for sexuality will be assessed using a 5-item Significance of Breast or Nipple Areolar Complex for Sexuality Questionnaire with 5 options to answer each question: Not at all, A little bit, Somewhat, Quite a bit, or Very much. Results will be reported descriptively.
Measured: At baseline and up to 12 months
Tactile sensitivity scores
Measured using Semmes Weinstein monofilament test. Scores will be averaged for each patient across all breast/ NAC measurements and summarized in terms of mean, standard deviation, median, and range. The ordinal score at each of the sites will also be summarized in terms of median and range. Frequency and type of missing data will be summarized.
Measured: At baseline and up to 12 months
Incidence of adverse events (AEs)
AEs will be scored using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) and will be summarized within arms by reporting the number and percentage of patients for each AE. The maximum grade for each type of AEs will be recorded for each patient and frequency tables will be reviewed to determine overall patterns. The frequency and type of solicited AEs experienced in each arm will also be reported.
Measured: At 12 months
Mastectomy skin flap necrosis
Incidence of mastectomy skin flap necrosis will be assessed using the skin ischemia necrosis (SKIN) score, as recorded by clinical staff. Necrosis is defined as any depth SKIN score of C or D and surface area >1.
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start5 Dec 2023
- Primary completion19 Jul 2028 (estimated)
- Study completion19 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage 0 Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James W. Jakub, M.D., Principal investigator, Mayo ClinicOlivia S. Ho, M.D., M.S., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153836
- Sponsor's protocol ID
- MC230302
- Other IDs
- NCI-2023-09574, 23-004411, MC230302
- Status last verified
- Sep 2026
- First submitted
- 22 Nov 2023
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Feasibility Study to Determine the Feasibility of Neurotization of the Nipple Areolar Complex at the Time of Nipple Sparing Mastectomy and Prosthetic Based Reconstruction
- ClinicalTrials.gov ID
- NCT06153836
- Acronym / sponsor ID
- MC230302
- Conditions
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 19 Jul 2028 (estimated)
- Study completion
- 19 Jul 2028 (estimated)
- First posted
- 1 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- To determine willingness of patients undergoing NSM to enroll in a randomized trial of NSM with or without neurotization.
SECONDARY OBJECTIVES:
- To compare patient reported outcomes, including quality of life and breast and NAC sexual functionality, for patients undergoing NSM with or without neurotization.
II. To compare NAC sensation at 12 months in patients undergoing NSM with or without neurotization.
III To determine rate of mastectomy skin flap necrosis following NSM via the skin ischemia and necrosis (SKIN) score.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo standard of care NSM on study.
ARM II: Patients undergo neurotization during standard of care NSM on study.
After completion of study intervention, patients are followed at 14 days and at 6, 12 and 24 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM I (control) | Active comparator | Other: Questionnaire Administration, Procedure: Subcutaneous MastectomyPatients undergo standard of care NSM on study. |
| ARM II (neurotization) | Experimental | Procedure: Neurotization Procedure, Other: Questionnaire Administration, Procedure: Subcutaneous MastectomyPatients undergo neurotization during standard of care NSM on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
Key exclusion criteria (2 listed)
- Planned autologous reconstruction (immediate or delayed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurotization ProcedureAlso: Nerve Regeneration ProcedureUndergo placement of nerve graft | Procedure or surgery | ARM II (neurotization) |
| Questionnaire AdministrationAncillary studies | Other | ARM I (control), ARM II (neurotization) |
| Subcutaneous MastectomyAlso: Nipple-Sparing MastectomyUndergo standard of care NSM | Procedure or surgery | ARM I (control), ARM II (neurotization) |
Primary outcome
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
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.
8 secondary outcomes
Chest physical well-being
Time frame: At baseline and up to 12 months
Psychosocial well-being
Time frame: At baseline and up to 12 months
Sexual well-being
Time frame: At baseline and up to 12 months
Patient reported amount of sensation in nipple areolar complex (NAC) and breast
Time frame: At baseline and up to 12 months
Patient reported significance of breast or NAC for sexuality
Time frame: At baseline and up to 12 months
Tactile sensitivity scores
Time frame: At baseline and up to 12 months
Incidence of adverse events (AEs)
Time frame: At 12 months
Mastectomy skin flap necrosis
Time frame: At 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James W. Jakub, M.D. principal investigator
Mayo Clinic
Olivia S. Ho, M.D., M.S. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neurotization Procedure, Questionnaire Administration and Subcutaneous Mastectomy in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.