Breast CancerRNSMNCT04151368
Surgical and Patient Reported Outcomes of Robotic Nipple-Sparing Mastectomy
A study testing Robotic Nipple-Sparing Mastectomy (RNSM) in people with Breast Cancer and Surgery--Complications, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Nipple-sparing mastectomy (NSM) with immediate reconstruction is one of the standard of care surgical treatments of breast cancer (BC) and is used for risk reduction in patients with a high risk for BC. Read more about this study
- Who is it for?
- Ages 20 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Surgery--Complications, Genetic Predisposition to Disease
- What is being tested?
- Robotic Nipple-Sparing Mastectomy (RNSM)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2019to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women of any age with invasive breast cancer (BC), ductal carcinoma in situ (DCIS), BRCA or other breast cancer genetic mutation carriers or high risk BC female patients who are otherwise candidates for NSM with IPBR will be eligible for the study. For those patients, RNSM-IPBR will be offered. Those who, after thorough discussion of risks and benefits, choose and consent to undergo RNSM-IPBR will be included in the study.
Who cannot join
- Heavy smokers (>20 cigarettes a day)
- Uncompensated Diabetes Mellitus
- High risk for anesthesia (ASA 4)
- Inflammatory Breast Cancer
- Previous thoracic radiation therapy for any reason
- Pregnancy
- Psychiatric, addictive, or any disorder which compromises ability to give informed consent for participation in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Robotic Nipple-Sparing Mastectomy With Immediate Prosthetic Breast Reconstruction: Prospective Study of Feasibility, Safety and Patient Satisfaction, Toronto Experience.
Nipple-sparing mastectomy (NSM) with immediate reconstruction is one of the standard of care surgical treatments of breast cancer (BC) and is used for risk reduction in patients with a high risk for BC. While this method shows satisfactory oncologic and good cosmetic outcomes, its drawbacks include compromise of the skin flap vascularization due to skin incision, nipple-areolar complex (NAC) malposition/distortion and visible scar on the breast. NSM also has technical challenges of dissecting and removing larger specimens through limited incisions and concerns regarding oncologic effectiveness due to difficulties in visualizing regions of the breast remote from the incision. To improve cosmetic outcomes after NSM, a modification of this technique using a surgical robotic system was recently described. In a limited number of studies, the robotic NSM (RNSM) with immediate prosthetic breast reconstruction (IPBR) was shown to be feasible and safe, as well as led to excellent cosmetic outcomes and patient satisfaction. There are limited number of centers in North America and none in Canada that offer RNSM-IPBR. The investigators hypothesize that RNSM-IPBR is a feasible and safe technique that can be utilized in our institution and that it can provide superior cosmetic outcomes with less morbidity and higher patient satisfaction compared to the traditional NSM-IPBR. The aim is to conduct a single-arm prospective study to investigate the safety and feasibility, as well as cosmetic, surgical complication and patient satisfaction parameters of NSM-IPBR performed in the University Health Network (UHN). This study will serve a foundation for potential introduction of a novel surgical approach in our institution and will make it available for treatment and prevention of breast cancer in Canadian women. The study will also serve as pilot data for future potential studies, including randomized-controlled trials (RCT) comparing RNSM with conventional NSM. As such, the study will further our approach to innovation in breast surgical oncology within Canada and North America.
Read the detailed description
This is a single-arm prospective study to assess feasibility and safety (primary outcomes), as well as patient satisfaction, cosmetic and oncologic outcomes of RNSM-IPBR in women with BC or at high risk of BC treated at UHN.
The objectives of the study are to determine:
- Feasibility of RNSM-IPBR through assessing operative parameters (such as time of procedure, robot docking time, conversion to conventional NSM-IPBR).
- Safety of RNSM-IPBR through assessing rate of morbidity from surgical complications (such as wound infection, flap and NAC necrosis, postoperative hematoma/bleeding, seroma requiring aspiration, implant loss, anesthesia related complications and need for reoperation with one month due to complications) and mortality due to the procedure.
- Patient satisfaction from RNSM-IPBR through assessing psychological, physical, sexual well-being, as well as satisfaction with breast, overall outcome and care through patient reported outcomes.
- Cosmetic outcomes of RNSM-IPBR, such as distortion or malposition of NAC and scarring, rate of reoperation due to unacceptable cosmetic outcomes.
- Short- and long-term oncologic outcomes of NSM-IPBR, such as positivity of margins, breast cancer incidence and recurrence rate, as well as overall survival.
The rationale of the study is to investigate a novel technique of RNSM-IPBR that might have superior cosmetic and patient satisfaction outcomes, as well as lower rates of complications, based on a small number of previously published studies from Europe and Asia.
Once enrolled, clinical, radiologic, and pathologic data will be collected for each participant at the initial visit and follow up data will be collected via available electronic patient records.
RNSM-IPBR will be performed by previously described method (Toesca et al.) using an extra-mammary axillary incision along the mid-axillary line in the axillary fossa. We will use Da Vinci Si Surgical System® (Intuitive Surgical, Sunnyvale, CA) available at Toronto General Hospital, UHN.
- Conditions
- Breast Cancer, Surgery--Complications, Genetic Predisposition to Disease, Surgery, BRCA1 Mutation, BRCA2 Mutation
- Being tested
- Robotic Nipple-Sparing Mastectomy (RNSM)
- Keywords
- breast surgery, robotic surgery, nipple sparing mastectomy, genetic predisposition, breast cancer
- Medical subject headings
- Breast Neoplasms, Genetic Predisposition to Disease, Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Nipple-Sparing Mastectomy (RNSM)Procedure or surgery
RNSM will be performed by previously described method using 3 cm extra-mammary axillary incision along the mid-axillary line in the axillary fossa. We will use Da Vinci Si Surgical System® (Intuitive Surgical, Sunnyvale, CA).
| Study group | Role | What they receive |
|---|---|---|
| Robotic Nipple Sparing Mastectomy Arm | Experimental | Patient cohort undergoing nipple sparing mastectomy with use of robotic dissection. Receives: Procedure: Robotic Nipple-Sparing Mastectomy (RNSM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of RNSM
Surgical time in minutes
Measured: 1 month
Wound complications
Skin and Nipple necrosis
Measured: 2 months
Margins after RNSM
Margin status (mm)
Measured: 1 month
Breast cancer recurrence
Site of first relapse
Measured: 36 months
Secondary outcomes (2)
Patient Satisfaction
Breast Q Pre and Post-operative Surveys- items measuring satisfaction with appearance, surgical experience, breast shape and symmetry, psychosocial, physical and sexual well being. Lowest score = 0, highest = 100 with higher scores indicating better outcomes / quality of life.
Measured: Pre-Operative and 6 and 12 months post-operative
Body Image
Hopwood's Body Image Scale- Scores range from 0 (min distress) to 3 (max distress) for 10 questions. Lowest score = 0, highest = 30 with lower scores indicated lower body image distress.
Measured: 6 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start1 Nov 2019
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: Recruitment has been temporarily suspended since the start of the pandemic due to the need for travel for this study. Will resume when appropriate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective Single Arm
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tulin D Cil, MD, MEd, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04151368
- Sponsor's protocol ID
- 19-5250.0
- Acronym
- RNSM
- Status last verified
- Jan 2025
- First submitted
- 30 Oct 2019
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Toesca A, Peradze N, Manconi A, Galimberti V, Intra M, Colleoni M, Bonanni B, Curigliano G, Rietjens M, Viale G, Sacchini V, Veronesi P. Robotic nipple-sparing mastectomy for the treatment of breast cancer: Feasibility and safety study. Breast. 2017 Feb;31:51-56. doi: 10.1016/j.breast.2016.10.009. Epub 2016 Nov 2.
PubMed 27810700Sarfati B, Struk S, Leymarie N, Honart JF, Alkhashnam H, Tran de Fremicourt K, Conversano A, Rimareix F, Simon M, Michiels S, Kolb F. Robotic Prophylactic Nipple-Sparing Mastectomy with Immediate Prosthetic Breast Reconstruction: A Prospective Study. Ann Surg Oncol. 2018 Sep;25(9):2579-2586. doi: 10.1245/s10434-018-6555-x. Epub 2018 Jun 29.
PubMed 29959612
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Nipple-Sparing Mastectomy With Immediate Prosthetic Breast Reconstruction: Prospective Study of Feasibility, Safety and Patient Satisfaction, Toronto Experience.
- ClinicalTrials.gov ID
- NCT04151368
- Acronym / sponsor ID
- RNSM / 19-5250.0
- Conditions
- Breast Cancer, Surgery--Complications, Genetic Predisposition to Disease, Surgery, BRCA1 Mutation, BRCA2 Mutation
- Keywords
- breast surgery, robotic surgery, nipple sparing mastectomy, genetic predisposition, breast cancer
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Recruitment has been temporarily suspended since the start of the pandemic due to the need for travel for this study. Will resume when appropriate.
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 5 Nov 2019 (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.
Nipple-sparing mastectomy (NSM) with immediate reconstruction is one of the standard of care surgical treatments of breast cancer (BC) and is used for risk reduction in patients with a high risk for BC. While this method shows satisfactory oncologic and good cosmetic outcomes, its drawbacks include compromise of the skin flap vascularization due to skin incision, nipple-areolar complex (NAC) malposition/distortion and visible scar on the breast. NSM also has technical challenges of dissecting and removing larger specimens through limited incisions and concerns regarding oncologic effectiveness due to difficulties in visualizing regions of the breast remote from the incision. To improve cosmetic outcomes after NSM, a modification of this technique using a surgical robotic system was recently described. In a limited number of studies, the robotic NSM (RNSM) with immediate prosthetic breast reconstruction (IPBR) was shown to be feasible and safe, as well as led to excellent cosmetic outcomes and patient satisfaction. There are limited number of centers in North America and none in Canada that offer RNSM-IPBR. The investigators hypothesize that RNSM-IPBR is a feasible and safe technique that can be utilized in our institution and that it can provide superior cosmetic outcomes with less morbidity and higher patient satisfaction compared to the traditional NSM-IPBR. The aim is to conduct a single-arm prospective study to investigate the safety and feasibility, as well as cosmetic, surgical complication and patient satisfaction parameters of NSM-IPBR performed in the University Health Network (UHN). This study will serve a foundation for potential introduction of a novel surgical approach in our institution and will make it available for treatment and prevention of breast cancer in Canadian women. The study will also serve as pilot data for future potential studies, including randomized-controlled trials (RCT) comparing RNSM with conventional NSM. As such, the study will further our approach to innovation in breast surgical oncology within Canada and North America.
Detailed description
This is a single-arm prospective study to assess feasibility and safety (primary outcomes), as well as patient satisfaction, cosmetic and oncologic outcomes of RNSM-IPBR in women with BC or at high risk of BC treated at UHN.
The objectives of the study are to determine:
- Feasibility of RNSM-IPBR through assessing operative parameters (such as time of procedure, robot docking time, conversion to conventional NSM-IPBR).
- Safety of RNSM-IPBR through assessing rate of morbidity from surgical complications (such as wound infection, flap and NAC necrosis, postoperative hematoma/bleeding, seroma requiring aspiration, implant loss, anesthesia related complications and need for reoperation with one month due to complications) and mortality due to the procedure.
- Patient satisfaction from RNSM-IPBR through assessing psychological, physical, sexual well-being, as well as satisfaction with breast, overall outcome and care through patient reported outcomes.
- Cosmetic outcomes of RNSM-IPBR, such as distortion or malposition of NAC and scarring, rate of reoperation due to unacceptable cosmetic outcomes.
- Short- and long-term oncologic outcomes of NSM-IPBR, such as positivity of margins, breast cancer incidence and recurrence rate, as well as overall survival.
The rationale of the study is to investigate a novel technique of RNSM-IPBR that might have superior cosmetic and patient satisfaction outcomes, as well as lower rates of complications, based on a small number of previously published studies from Europe and Asia.
Once enrolled, clinical, radiologic, and pathologic data will be collected for each participant at the initial visit and follow up data will be collected via available electronic patient records.
RNSM-IPBR will be performed by previously described method (Toesca et al.) using an extra-mammary axillary incision along the mid-axillary line in the axillary fossa. We will use Da Vinci Si Surgical System® (Intuitive Surgical, Sunnyvale, CA) available at Toronto General Hospital, UHN.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective Single Arm
| Arm | Type | Receives |
|---|---|---|
| Robotic Nipple Sparing Mastectomy Arm | Experimental | Procedure: Robotic Nipple-Sparing Mastectomy (RNSM)Patient cohort undergoing nipple sparing mastectomy with use of robotic dissection. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women of any age with invasive breast cancer (BC), ductal carcinoma in situ (DCIS), BRCA or other breast cancer genetic mutation carriers or high risk BC female patients who are otherwise candidates for NSM with IPBR will be eligible for the study. For those patients, RNSM-IPBR will be offered. Those who, after thorough discussion of risks and benefits, choose and consent to undergo RNSM-IPBR will be included in the study.
Key exclusion criteria (7 listed)
- Heavy smokers (>20 cigarettes a day)
- Uncompensated Diabetes Mellitus
- High risk for anesthesia (ASA 4)
- Inflammatory Breast Cancer
- Previous thoracic radiation therapy for any reason
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 |
|---|---|---|
| Robotic Nipple-Sparing Mastectomy (RNSM)RNSM will be performed by previously described method using 3 cm extra-mammary axillary incision along the mid-axillary line in the axillary fossa. We will use Da Vinci Si Surgical System® (Intuitive Surgical, Sunnyvale, CA). | Procedure or surgery | Robotic Nipple Sparing Mastectomy Arm |
Primary outcome
Feasibility of RNSM
Time frame: 1 month
Surgical time in minutes
Wound complications
Time frame: 2 months
Skin and Nipple necrosis
Margins after RNSM
Time frame: 1 month
Margin status (mm)
Breast cancer recurrence
Time frame: 36 months
Site of first relapse
2 secondary outcomes
Patient Satisfaction
Time frame: Pre-Operative and 6 and 12 months post-operative
Body Image
Time frame: 6 months post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Background: PubMed 27810700Toesca A, Peradze N, Manconi A, Galimberti V, Intra M, Colleoni M, Bonanni B, Curigliano G, Rietjens M, Viale G, Sacchini V, Veronesi P. Robotic nipple-sparing mastectomy for the treatment of breast cancer: Feasibility and safety study. Breast. 2017 Feb;31:51-56. doi: 10.1016/j.breast.2016.10.009. Epub 2016 Nov 2.
- Background: PubMed 29959612Sarfati B, Struk S, Leymarie N, Honart JF, Alkhashnam H, Tran de Fremicourt K, Conversano A, Rimareix F, Simon M, Michiels S, Kolb F. Robotic Prophylactic Nipple-Sparing Mastectomy with Immediate Prosthetic Breast Reconstruction: A Prospective Study. Ann Surg Oncol. 2018 Sep;25(9):2579-2586. doi: 10.1245/s10434-018-6555-x. Epub 2018 Jun 29.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Tulin D Cil, MD, MEd principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Nipple-Sparing Mastectomy (RNSM) in people with Breast Cancer and Surgery--Complications, run by University Health Network, Toronto at 1 site in Canada.
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 1 inclusion and 7 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: paused, as of the sponsor's last update on 31 Jan 2025. 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 Canada. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of RNSM (time frame: 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04151368, which also lists 2 linked publications.
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 31 Jan 2025.