Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Carcinoma In Situ

Carcinoma

Carcinoma in Situ

Breast Diseases

Skin Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Patients undergo standard of care NSM on study.

Patients undergo neurotization during standard of care NSM on study.

Neurotization Procedure

Questionnaire Administration

Subcutaneous Mastectomy

Clinical Trials Referral Office

James W. Jakub, M.D.

Olivia S. Ho, M.D., M.S.

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.

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.

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

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

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 using the BREAST- Q (copyright) scored on a 5-point Likert scale. Results will be reported descriptively.

Measured using the BREAST- Q scored on a 5-point Likert scale. Results will be reported descriptively.

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. Results will be reported descriptively.

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. Results will be reported descriptively.

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.

AEs, using National Cancer Institute Common Terminology Criteria for Adverse Events, will be summarized within arms by reporting the number and percentage of patients. 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.

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.

Mayo Clinic

subcutaneous mastectomy

Operating endoscopic subcutaneous mastectomy

endoscopic subcutaneous mastectomy

Zhongtao Zhang,, MD

The consideration of quality of life issues has led to the development of alternative surgeries for breast cancer patients, particularly in the case of localized disease. Nipple-sparing subcutaneous mastectomy (SM), for example, was designed to preserve the nipple-areola complex which facilitates breast reconstruction. However, SM still leaves behind a conspicuous scar.There have already been some observation study show that endoscopic subcutaneous mastectomy(ESM) can improve the cosmesis outcomes and at the same time as safe as the traditional SM.However there is no RCT in this field.That is why the investigators design this study.

ESM Versus OM ：A Randomized Controlled Trial

A Randomized Controlled Trial of Endoscopic Subcutaneous Mastectomy Versus Open Mastectomy in Early Breast Cancer Patients

Definition and diagnostic criteria of local recurrence: physical examination or imaging examination found lesions in the same side of breast, chest wall or skin and surgical scars, and confirmed by histology as breast cancer of the same tissue type; 12 months after operation, the evaluation was carried out.

Definition and diagnosis criteria of distant metastasis: the lesions appeared in the distant organs other than breast and surrounding tissues, such as bone, lung, liver, brain, etc., and were diagnosed as breast cancer metastasis by imaging or histology; the evaluation was carried out 12 months after operation.

Beijing Friendship Hospital

Director of general surgery, principal investigator

Symptoms and General Pathology

Genetic Predisposition to Disease

Disease Susceptibility

Disease Attributes

20 patients female with genetic risk for breast cancer and who ask for prophylactic mastectomy. They will have a prophylactic mastectomy with immediate breast reconstruction

It is an endoscopic approach for prophylactic mastectomy using an axillary single port

Prophylactic mastectomy with immediate breast reconstruction

Gauthier Rathat, MD

Implant-based reconstruction is currently the most common choice for mastectomy reconstruction. Whatever the choice of mastectomy incision, a scar remains on or near the breast volume. Current techniques involve partial or total coverage of the implant with the pectoralis major muscle, to prevent exposure or infection. The muscle dissection technique applied has functional and cosmetic consequences. In this study, an endoscopic approach will be evaluated. This new surgical technique, using a single-port endoscopic way, will put the scar is in the axillary area, away from the breast. The hypothesis is that this delocalized scar potentially reduces the risk of exposure and allows placement of the implant in the subcutaneous space, with no manipulation of the pectoralis major muscle.

It s a practicability study, evaluating endoscopic approach for prophylactic mastectomy, using an axillary single port. Classic open surgery conversion rate, operative time, infectious rate, esthetical outcomes, and functional outcomes will be evaluated.

Pre Pectoral Implant for Immediate Breast Reconstruction Using Single Port Endoscopy in Prophylactic Indication

The total mastectomy is done by a scar in the axillary area, away from the breast, using single port endoscopy, with Implant base reconstruction in pre pectoral position.

Complete excision of the gland by means of an incision on the axillary line, Installation of a definitive smooth prosthesis, Absence of conversion to a conventional approach, No skin necrosis

Duration of the prophylactic mastectomy with immediate breast reconstruction

Number of participants with early postoperative infection two months after the prophylactic mastectomy

Blood loss (milliliters) during the prophylactic mastectomy with immediate breast reconstruction

Number of participants with a local haematoma caused by the prophylactic mastectomy with immediate breast reconstruction

Number of patients with disunity of the scar after the prophylactic mastectomy

Number of patients with the prothesis exposed after the prophylactic mastectomy

Number of patients with seromas after the prophylactic mastectomy

Refractory induced hypercapnia: EtCO2 (expired fraction of CO2)\> 45mmHg and refractory to ventilation ; second degree secondary burn

The presence of skin case necrosis will be noted during all the visits after the surgery. It's severe if \> 25%

The presence of necrosis of areolo-nipple plaque will be noted during all the visits after the surgery.

The level of pain of the operated breasts will be self-assessed by the patient with EVA at 1, 3, 6, 12 months after the surgery. EVA is mesured between 0 and 10 (0: no pain ; 10: extremely intense pain)

The duration of hospitalization will be noted upon discharge from hospitalization

BREAST-Q© questionnaire Version 2.0 measure the quality of life and satisfaction among patients undergoing breast surgery. This questionnaire includes 6 modules: 1) Augmentation module, 2) Reduction/Mastectomy module, 3) Breast cancer: a) Mastectomy module, b) Reconstruction module, c) Breast reconstruction expectations module, d) Breast conserving therapy module.

The conceptual framework of the modules is comprised of following two overarching themes (or domains): 1) Health-related quality of life and 2) Patient satisfaction. 1) Under each of these domains, there are six subthemes; Quality of life: 1) Psychosocial, 2) Physical and 3) Sexual well-being; and Patient satisfaction: 4) Satisfaction with Breasts, 5) Satisfaction with Outcome and 6) Satisfaction with care.

Cf. https://qportfolio.org/wp-content/uploads/2020/BREAST-Q-USERS-GUIDE-V2.pdf for the response options.

the need to use one or more lipomodelages

Evaluation of the Constant score by a physiotherapist from the gynecology Department. The Constant score includes 5 items: Pain \[0;5\], Daily activity level \[0;10\], Level of work with the hand \[0;10\], Mobility \[0;40\] and Muscular force \[0;25\].

The Constant score is mesured between 0 and 100. The higher the score, the fewer problems there are for the patient, 100 is the ideal score.

Quality of life with an european quality of life scale (EQ-5D-3L). The EQ-5D-3L descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neurotization of the Nipple Areolar Complex to Restore Sensation for Patients With Breast Cancer Undergoing Nipple Sparing Mastectomy and Reconstruction	NCT06153836	Anatomic Stage ... Anatomic Stage ... Anatomic Stage ...	Neurotization P... Questionnaire A... Subcutaneous Ma...	18 Years -	Mayo Clinic
ESM Versus OM ：A Randomized Controlled Trial	NCT04461847	Endoscopic Subc...	subcutaneous ma... endoscopic subc...	18 Years - 70 Years	Beijing Friendship Hospital
Neurotization of the Nipple Areolar Complex to Restore Sensation for Patients With Breast Cancer Undergoing Nipple Sparing Mastectomy and Reconstruction	NCT06153836	Anatomic Stage ... Anatomic Stage ... Anatomic Stage ...	Neurotization P... Questionnaire A... Subcutaneous Ma...	18 Years -	Mayo Clinic
Pre Pectoral Implant for Immediate Breast Reconstruction Using Single Port Endoscopy in Prophylactic Indication	NCT03838549	Genetic Predisp... Breast Cancer	Prophylactic ma...	20 Years -	University Hospital, Montpellier
Pre Pectoral Implant for Immediate Breast Reconstruction Using Single Port Endoscopy in Prophylactic Indication	NCT03838549	Genetic Predisp... Breast Cancer	Prophylactic ma...	20 Years -	University Hospital, Montpellier

Spots Global Cancer Trial Database for subcutaneous mastectomy