Clinical trial NCT04108117: Surgical and Oncologic Outcomes After Robotic Nipple Sparing Mastectomy and Immediate Reconstruction
Official title: Surgical and Oncologic Outcomes After Robotic Nipple Sparing Mastectomy and Immediate Reconstruction : an International Multicenter Pooled Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Complications
Recurrence
Breast Neoplasms
Breast Cancer
BRCA1 Mutation
BRCA2 Mutation
Surgery
Surgery--Complications
Keywords: Robotic mastectomy
Breast neoplasms
Postoperative complications
Recurrence
Prognosis
Survivals
Nipple sparing mastectomy
Immediate reconstruction
Lead sponsor: Severance Hospital
Sponsor class: OTHER
Collaborators: name: European Institute of Oncology
name: Changhua Christian Hospital
name: Samsung Medical Center
First posted: 2019-09-27
Enrollment: 659
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent nipple-sparing mastectomy between 2016 and 2020 at Severance Hospital, Seoul, Korea.

Patients who underwent nipple-sparing mastectomy between 2016 and 2020 at Samsung Medical Center, Seoul, Korea.

Patients who underwent nipple sparing mastectomy between 2014 and 2019 at European Institute of Oncology, Milan, Italy.

Patients who underwent nipple-sparing mastectomy between 2017 and 2019 at Changhua Christian Hospital, Changhua City, Taiwan.

Patients who underwent nipple-sparing mastectomy between 2015 and 2019 at Gustave Roussy, Paris, France.

Brief summary: Robotic mastectomy with immediate reconstruction was introduced by Toesca et al. in 2015. Since then, several studies have reported the safety and feasibility of robotic nipple-sparing mastectomy with immediate reconstruction. However, most studies were conducted by single centers and had small samples. Furthermore, there is a lack of studies comparing surgical and oncologic outcomes between robotic nipple-sparing mastectomy and conventional nipple-sparing mastectomy. For this reason, this study evaluates surgical and oncologic outcomes of robotic nipple-sparing mastectomy with immediate reconstruction using international multi-center data.

Detailed description: This study is an international multi-center pooled analysis using prospective and retrospective studies to evaluate surgical and oncologic outcomes of robotic nipple-sparing mastectomy with immediate reconstruction.

Raw data for robotic or conventional nipple-sparing mastectomy from Severance Hospital, Samsung Medical Center, the European Institute of Oncology, Changhua Christian Hospital, and Gustave Roussy is collected. Among them, Severance Hospital takes the lead at performing analysis from the data. Storage and disposal of patients' records are managed by each researcher. In the analysis process, although the collaborators can request records from Severance Hospital if necessary, they are only supposed to be provided computerized data which were originally clinical data from patients who already ended treatments. In this case, individual identifying data and medical records are not shown.

Clinicopathologic variables including operation times, hospital stay, medical history, smoking history, family history, BMI, menopausal status, specimen weight, TNM stage, grade, histological type, estrogen receptor, progesterone receptor, HER2, Ki 67, and perivascular involvement are analyzed.

Postoperative complications within 30 days are collected and classified by the Clavien-Dindo grade. Locoregional recurrence-free survival and local and systemic recurrences are examined. Patients whose data have been retrospective for at least one month are to be examined.

Patient's and surgeon's satisfaction using Breast Q is evaluated. Categorical variables are examined using the chi-square test or Fisher's exact test if indicated.

Continuous variables are examined using the independent t-test or ANOVA if indicated.

The estimated sample size from the four institutions is about 300 cases for robotic nipple-sparing mastectomy and matched cases for conventional nipple-sparing mastectomy.

Propensity matching analysis is applied to reduce confounding factors.

Eligibility criteria: Inclusion Criteria:

* Women who underwent nipple sparing mastectomy and immediate reconstruction
* Women with early breast cancer
* Women with germline BRCA 1/2 mutation or germline mutations in genetic susceptibility genes
* Women with interstitial mastopathy
* Women with risk-reducing mastectomy or contralateral mastectomy

Exclusion Criteria:

* Male patients
* Women with stage IV disease at diagnosis
* Women who underwent previous breast cancer surgery
* Women who received prior radiotherapy for the ipsilateral breast

Primary outcomes:
measure: Postoperative complication rates in 30 days
timeFrame: Postoperative 30 days
measure: Clavien-Dindo grade of postoperative complications
timeFrame: Postoperative 30 days
measure: Nipple necrosis rates
timeFrame: Postoperative 30 days
measure: Recurrence free survival (RFS)
timeFrame: Postoperative 5 years
Secondary outcomes:
measure: Operation times
timeFrame: Time during operation
measure: Locoregional recurrence-free survival (LRFS)
timeFrame: Postoperative 5 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine
Study officials:
affiliation: Severance Hospital
name: Hyung Seok Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: European Institute of Oncology
name: Antonio Toesca, MD
role: PRINCIPAL_INVESTIGATOR
References:
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