Pilot Study of Single-port Robot-assisted Nipple-sparing Mastectomy
Nipple-sparing Mastectomy, Prophylactic Mastectomy, Breast Cancer
About this trial
This is an interventional treatment trial for Nipple-sparing Mastectomy focused on measuring robotic mastectomy, robot-assisted mastectomy, nipple-sparing mastectomy, axillary lymph node dissection, breast cancer surgery, breast reconstruction, prophylactic mastectomy, single-port systems
Eligibility Criteria
Inclusion Criteria:
Women with unilateral or bilateral breast cancer, including invasive and noninvasive carcinoma, eligible for unilateral or bilateral nipple-sparing mastectomy (NSM), either for therapeutic or prophylactic purpose, followed by immediate breast reconstruction.
Meet at least one of the following indications of NSM for breast cancer:
- Preoperative clinical tumor sizes less than 5 cm, with adequate tumor-skin distance of at least 3mm and above, and without nipple-areolar involvement in at least 1cm around the nipple by image
- Breast cancer up to stage IIIa (T3, N1-2) as the initial clinical stage showing adequate response to neoadjuvant therapy and meet criteria a.
- Germline pathogenic/likely pathogenic BRCA1 or 2 mutation carriers (actionable mutations including pathogenic and likely pathogenic mutations) with breast cancer diagnosis or requiring unilateral or bilateral prophylactic mastectomy as a risk reduction procedure
- Age equal to or above 20 years
- ECOG (Eastern Cooperative Oncology Group) performance score 0-1
- ASA anesthesia risk class 1~2, and with adequate organ functions
- Understanding of the method, benefit and risk and willing to receive immediate breast reconstruction
Exclusion Criteria:
- Extensive breast skin or nipple involvement by cancer including 1) Paget's disease, 2) nipple discharge associated with malignancy, 3) image findings suggesting involvement of the nipple and subareolar tissues 4) inflammatory breast cancer or skin ulceration caused by cancer invasion
- Stage III (up to T3, N1-2) breast cancer without response to neoadjuvant treatment
- Previous radiotherapy on the surgical site of breast
- Patients with severe systemic disease reaching ASA (American Society of Anesthesiologists) physical status classification equal or greater than 3
- Patients with bleeding disorder or coagulopathy
- Patients with BMI 35.0 or higher
- Patients with habitual smoking
- Pregnancy
Sites / Locations
- Chang Gung Memeorial Hospital, Linkou Medical Center
Arms of the Study
Arm 1
Experimental
Robotic mastectomy
Patients receive unilateral or bilateral robot-assisted nipple-sparing mastectomy with or without axillary lymph node dissection