Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8
Conditions
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.
Detailed description
PRIMARY OBJECTIVE: I. To determine willingness of patients undergoing NSM to enroll in a randomized trial of NSM with or without neurotization. SECONDARY OBJECTIVES: I. 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.
Interventions
PROCEDURENeurotization Procedure
Undergo placement of nerve graft
OTHERQuestionnaire Administration
Ancillary studies
PROCEDURESubcutaneous Mastectomy
Undergo standard of care NSM
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients undergoing nipple sparing mastectomy (NSM) to enroll in a randomized trial of NSM with or without neurotization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient reported significance of breast or NAC for sexuality | At baseline and up to 12 months | 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. |
| Tactile sensitivity scores | At baseline and up to 12 months | 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. |
| Incidence of adverse events (AEs) | At 12 months | 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. |
| Patient reported amount of sensation in nipple areolar complex (NAC) and breast | At baseline and up to 12 months | 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. |
| Chest physical well-being | At baseline and up to 12 months | 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. |
| Psychosocial well-being | At baseline and up to 12 months | 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. |
| Sexual well-being | At baseline and up to 12 months | 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. |
| Mastectomy skin flap necrosis | At 12 months | 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. |
Countries
United States
Contacts
CONTACTClinical Trials Referral Office
PRINCIPAL_INVESTIGATORJames W. Jakub, M.D.
Mayo Clinic
PRINCIPAL_INVESTIGATOROlivia S. Ho, M.D., M.S.
Mayo Clinic
Outcome results
None listed