Breast CancerNCT06860217
Robotic Nipple Sparing Mastectomy with Immediate Reconstruction
A study testing Robotic Nipple-Sparing Mastectomy in people with Breast Cancer and DCIS, run by European Institute of Oncology at 1 site in Italy.
Trial summary
Aim of this trial is to verify whether the patients' quality of life can be improved by a less invasive surgical procedure and whether the use of robotic technique for nipple-sparing mastectomy associated to prepectoral direct implant procedure can impact on perioperative and postoperative period and on oncologic… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer, DCIS, BRCA Mutation
- What is being tested?
- Robotic Nipple-Sparing Mastectomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2025to Apr 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Candidates to nipple-sparing mastectomy and immediate breast reconstruction for invasive breast cancer, ductal carcinoma in situ (DCIS), BReast CAncer gene (BRCA) mutation carriers
- Any age
- Negative preoperative assessment of nipple-areola complex
- Absence of skin involvement
- Low probability to have positivity of nipple-areola complex tissue intra-operative frozen section
- Breast volume ≤ Bra IV
Show all 10Show fewer
- No hard smoking (defined as <=20 cigarettes/day)
- Low and intermediate risk for anesthesia (American Society of Anesthesiologists (ASA) Scale)
- Written informed consent must be signed and dated by the patient and the investigator prior to inclusion.
- Patients must be accessible for follow-up
Who cannot join
- Previous thoracic radiation therapy for any reason
- Inflammatory Breast Cancer
- Pregnancy
- Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study.
- Uncompensated Diabetes Mellitus
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
European Institute of Oncology
Milan, 20141
Paolo Veronesi, MD, +39 0294371091, paolo.veronesi@ieo.it
About this study
Official title: Robotic Nipple Sparing Mastectomy with Immediate Reconstruction with Prepectoral Implant: a Single Center, Prospective Trial
Aim of this trial is to verify whether the patients' quality of life can be improved by a less invasive surgical procedure and whether the use of robotic technique for nipple-sparing mastectomy associated to prepectoral direct implant procedure can impact on perioperative and postoperative period and on oncologic outcome.
Read the detailed description
Muscle coverage, whether total or partial, has been historically advocated as the preferred approach after nipple sparing mastectomy because it adds an additional layer of vascularized coverage to the implant. However, current practices have evolved toward prepectoral implant reconstruction as it reduces animation deformity, pain, and muscle spasms, compared with the subpectoral approach, while maintaining optimal esthetic results. One of the limitations to the use of the prepectoral (subcutaneous) implant in ordinary surgery (open technique) is related to the fact that the implant is in direct contact with the surgical wound, giving reasons of high rate of implant loss due to wound dehiscence.
In this sense, the extra-mammary localization of the surgical wound (as during robotic mastectomy) allows the positioning of the prepectoral implant in greater safety.
Robotic nipple-sparing mastectomy with immediate breast prepectoral implant reconstruction may allow for more precise anatomic dissection and improved cosmetic outcomes over conventional open nipple-sparing mastectomy with retro-pectoral implant reconstruction; however, data about the feasibility, safety of the prepectoral reconstruction is limited as well as Quality of Life (QoL) evaluation.
The aim of this single center, prospective trial is to analyze the perioperative data, postoperative complications, oncologic outcomes as well as to analyze the patient reported outcome measures (PROMs) of 24 consecutive patients undergoing robotic nipple-sparing mastectomy and reconstruction with prepectoral implant. Concomitant endpoint is to compare operative features outcome measures and post-operative outcome complications.
A second-phase time line is to evaluate the long-term analysis of cumulative incidence of loco-regional recurrence, distant recurrences, the disease free survival and the overall survival with a median follow up of 5 years.
- Conditions
- Breast Cancer, DCIS, BRCA Mutation
- Being tested
- Robotic Nipple-Sparing Mastectomy
- Keywords
- Robotic Mastectomy, Nipple-sparing mastectomy, Breast reconstruction
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Nipple-Sparing MastectomyOther
Patient will undergo to nipple sparing mastectomy and breast reconstruction, conducted using robot
| Study group | Role | What they receive |
|---|---|---|
| Robotic Nipple-Sparing Mastectomy | Experimental | Surgical technique conducted using robot to perform nipple sparing mastectomy and breast reconstruction Receives: Other: Robotic Nipple-Sparing Mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgery time
Evaluation of average length of robotic procedure
Measured: 1 month
Post operative complications
Number of post operative complications (pain, skin or nipple-areola injury or necrosis or infection, hematoma, seroma)
Measured: 1 month
Post operative pain
Evaluation of postoperative pain by White and Song scale (minimum value: 0, maximum value: 2 - lower scores indicate higher pain)
Measured: 1 month
Length of stay of patients
Evaluation of average length of stay of patients
Measured: 1 month
Patient quality of life after surgery
Completion of BREAST-Q questionnaire (higher answers to each item reflect a better outcome)
Measured: 5 years
Patient satisfaction regarding body image
Completion of Hopwood's body image scale (BIS) questionnaire (minimum value: 0, maximum value: 3 - higher scores indicate lower satisfaction)
Measured: 5 years
Patient satisfaction reagarding nipple areola complex
Completion of Nipple Areola Complex (NAC) questionnaire (minimum value: 1, maximum value: 5 - higher scores mean a greater agreement with the statement)
Measured: 5 years
Secondary outcomes (5)
Cumulative incidence of local recurrence
Number of local recurrence
Measured: 5 years
Cumulative incidence of axillary recurrences
Number of axillary recurrences
Measured: 5 years
Cumulative incidence of distant recurrences
Number of distant recurrences
Measured: 5 years
Disease-free survival (DFS)
Interval from surgery to recurrence of disease
Measured: 5 years
Overall survival (OS)
Interval from surgery to death or last known alive date
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study startApr 2025 (estimated)
- Primary completionApr 2032 (estimated)
- Study completionApr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single center prospective trial
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paolo Veronesi, MD, Principal investigator, European Istitute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860217
- Sponsor's protocol ID
- IEO 1649
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2025
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Nipple Sparing Mastectomy with Immediate Reconstruction with Prepectoral Implant: a Single Center, Prospective Trial
- ClinicalTrials.gov ID
- NCT06860217
- Acronym / sponsor ID
- IEO 1649
- Conditions
- Breast Cancer, DCIS, BRCA Mutation
- Keywords
- Robotic Mastectomy, Nipple-sparing mastectomy, Breast reconstruction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Apr 2032 (estimated)
- Study completion
- Apr 2032 (estimated)
- First posted
- 5 Mar 2025 (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.
Aim of this trial is to verify whether the patients' quality of life can be improved by a less invasive surgical procedure and whether the use of robotic technique for nipple-sparing mastectomy associated to prepectoral direct implant procedure can impact on perioperative and postoperative period and on oncologic outcome.
Detailed description
Muscle coverage, whether total or partial, has been historically advocated as the preferred approach after nipple sparing mastectomy because it adds an additional layer of vascularized coverage to the implant. However, current practices have evolved toward prepectoral implant reconstruction as it reduces animation deformity, pain, and muscle spasms, compared with the subpectoral approach, while maintaining optimal esthetic results. One of the limitations to the use of the prepectoral (subcutaneous) implant in ordinary surgery (open technique) is related to the fact that the implant is in direct contact with the surgical wound, giving reasons of high rate of implant loss due to wound dehiscence.
In this sense, the extra-mammary localization of the surgical wound (as during robotic mastectomy) allows the positioning of the prepectoral implant in greater safety.
Robotic nipple-sparing mastectomy with immediate breast prepectoral implant reconstruction may allow for more precise anatomic dissection and improved cosmetic outcomes over conventional open nipple-sparing mastectomy with retro-pectoral implant reconstruction; however, data about the feasibility, safety of the prepectoral reconstruction is limited as well as Quality of Life (QoL) evaluation.
The aim of this single center, prospective trial is to analyze the perioperative data, postoperative complications, oncologic outcomes as well as to analyze the patient reported outcome measures (PROMs) of 24 consecutive patients undergoing robotic nipple-sparing mastectomy and reconstruction with prepectoral implant. Concomitant endpoint is to compare operative features outcome measures and post-operative outcome complications.
A second-phase time line is to evaluate the long-term analysis of cumulative incidence of loco-regional recurrence, distant recurrences, the disease free survival and the overall survival with a median follow up of 5 years.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single center prospective trial
| Arm | Type | Receives |
|---|---|---|
| Robotic Nipple-Sparing Mastectomy | Experimental | Other: Robotic Nipple-Sparing MastectomySurgical technique conducted using robot to perform nipple sparing mastectomy and breast reconstruction |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Candidates to nipple-sparing mastectomy and immediate breast reconstruction for invasive breast cancer, ductal carcinoma in situ (DCIS), BReast CAncer gene (BRCA) mutation carriers
- Any age
- Negative preoperative assessment of nipple-areola complex
- Absence of skin involvement
- Low probability to have positivity of nipple-areola complex tissue intra-operative frozen section
Key exclusion criteria (5 listed)
- Previous thoracic radiation therapy for any reason
- Inflammatory Breast Cancer
- Pregnancy
- Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study.
- Uncompensated Diabetes Mellitus
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 MastectomyPatient will undergo to nipple sparing mastectomy and breast reconstruction, conducted using robot | Other | Robotic Nipple-Sparing Mastectomy |
Primary outcome
Surgery time
Time frame: 1 month
Evaluation of average length of robotic procedure
Post operative complications
Time frame: 1 month
Number of post operative complications (pain, skin or nipple-areola injury or necrosis or infection, hematoma, seroma)
Post operative pain
Time frame: 1 month
Evaluation of postoperative pain by White and Song scale (minimum value: 0, maximum value: 2 - lower scores indicate higher pain)
Length of stay of patients
Time frame: 1 month
Evaluation of average length of stay of patients
Patient quality of life after surgery
Time frame: 5 years
Completion of BREAST-Q questionnaire (higher answers to each item reflect a better outcome)
Patient satisfaction regarding body image
Time frame: 5 years
Completion of Hopwood's body image scale (BIS) questionnaire (minimum value: 0, maximum value: 3 - higher scores indicate lower satisfaction)
Patient satisfaction reagarding nipple areola complex
Time frame: 5 years
Completion of Nipple Areola Complex (NAC) questionnaire (minimum value: 1, maximum value: 5 - higher scores mean a greater agreement with the statement)
5 secondary outcomes
Cumulative incidence of local recurrence
Time frame: 5 years
Cumulative incidence of axillary recurrences
Time frame: 5 years
Cumulative incidence of distant recurrences
Time frame: 5 years
Disease-free survival (DFS)
Time frame: 5 years
Overall survival (OS)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
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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.
Paolo Veronesi, MD principal investigator
European Istitute of Oncology
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 in people with Breast Cancer and DCIS, run by European Institute of Oncology at 1 site in Italy.
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 10 inclusion and 5 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: opening soon, as of the sponsor's last update on 5 Mar 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paolo Veronesi, MD (+39 0294371091, paolo.veronesi@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgery time (time frame: 1 month). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2025.