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Breast CancerNCT03440398

Robotic Nipple-Sparing Mastectomy Vs Conventional Open Technique

A study testing Robotic NSM and Open NSM in people with Breast Cancer, run by European Institute of Oncology at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This trial is designed to compare robotic nipple-sparing mastectomy and immediate robotic breast reconstruction with conventional open technique. It is a prospective randomized trial evaluating patients satisfaction Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Robotic NSM and Open NSM
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
1 siteItaly
Study dates
31 Mar 2017to 1 Feb 2026
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Invasive breast cancer, Ductal Carcinoma In Situ, Breast Related Cancer Antigens mutation carriers.
  • Any age
  • Candidates to nipple-sparing mastectomy and immediate breast reconstruction
  • 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
Show all 11Show fewer
  • Breast volume ≤ Bra IV; from cup A to D
  • No hard smoking (hard smoking defined as >20 cigarettes/day)
  • Low and intermediate risk for anesthesia (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
  • Skin involvement
  • Pre-operative diagnosis (radiological or cytological) of nipple-areola complex disease
  • Pregnancy
  • Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study
Show all 9Show fewer
  • Uncompensated Diabetes Mellitus
  • Hard smokers (hard smoking defined as >20 cigarettes/day)
  • High risk for anesthesia

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • European Institute of Oncology

    Milan, 20141

Other trials in Italy

About this study

Official title: Robotic Nipple-Sparing Mastectomy And Immediate Robotic Breast Reconstruction Vs Conventional Open Technique: A Prospective Randomized Trial Evaluating Patients Satisfaction

This trial is designed to compare robotic nipple-sparing mastectomy and immediate robotic breast reconstruction with conventional open technique. It is a prospective randomized trial evaluating patients satisfaction

Read the detailed description

High proportion of patients with newly diagnosed early-stage breast cancer in Europe and US undergo to mastectomy. The absolute numbers of mastectomy rates in US is still today around 38% and represent one of the most performed operation for cancer reasons. Despite the lack of a natural cavity needed for endoscopic viewing, applications of robotic surgery have recently emerged for superficial organs such as in the fields of thyroidectomy, oropharyngeal surgery, plastic and reconstructive surgery. However, it has never been applied in breast cancer except for a feasibility and safety study conducted at European Institute of Oncology.

The technique was firstly published by Toesca et al. considering the first 3 cases. The same research as continued on breast cancer evaluating feasibility, reproducibility and safety studying 26 consecutive procedures of robotic nipple sparing mastectomy and immediate robotic breast reconstruction (article under peer to peer review at European Journal of Surgical Oncology, EJSO). In these initial cases of robotic nipple sparing mastectomy and immediate breast reconstruction authors found two main advantages such as the robotic optical vision and the minimal invasiveness. The two main limitations noticed in this initial experience were the duration of operating time and the additional costs related to the operation. The limitations of the applicability of robotic surgery to the breast, such as operating time and costs, might be offset by the advantages they observed such as better vision and minimally invasive approach with an anatomically more respectful mastectomy.

This project is a superiority trial comparing robotic nipple sparing mastectomy and immediate breast robotic reconstruction with conventional open technique.

The primary end-point is to evaluate patient satisfaction. Second end-point is to compare post-operative outcome considering complications, post-operative pain, reduction of the average length of stay of patients, long term oncological outcome of the two different surgical techniques.

Patients will be randomized into two treatment arms:

  1. Open nipple-sparing mastectomy and immediate breast reconstruction with implant (Open NSM) B. Robotic nipple-sparing mastectomy and immediate robotic breast reconstruction with implant (Robotic NSM) Both arms will undergo to the same pre-surgical staging, intra-operative axillary surgical staging, post-operative multidisciplinary evaluation and adjuvant treatments according to international and internal protocols.
Conditions
Breast Cancer
Being tested
Robotic NSM, Open NSM
Keywords
Robotic Mastectomy, Nipple Sparing Mastectomy, Conservative mastectomy, Breast reconstruction
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Robotic NSMProcedure or surgery

    Surgical technique conducted using robot to perform nipple sparing mastectomy and breast reconstruction

  • Open NSMProcedure or surgery

    Open nipple-sparing mastectomy and immediate breast reconstruction with implant

Study groups in NCT03440398
Study groupRoleWhat they receive
Open NSMActive comparatorConventional Nipple Sparing Mastectomy
Receives: Procedure: Open NSM
Robotic NSMExperimentalRobotic Nipple-Sparing Mastectomy
Receives: Procedure: Robotic NSM

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient satisfaction

    The BREAST-Q survey is used to detect differences in patient satisfaction among the groups

    Measured: 1 year

Secondary outcomes (7)

  1. Average length of stay of patients

    Reduction of the average length of stay of patients of the two different surgical techniques.

    Measured: 1 month

  2. Post operative complications

    Compare post operative complications (pain, skin or nipple-areola injury or necrosis or infection, hematoma, seroma)

    Measured: 1 month

  3. Cumulative incidence of local recurrence

    Cumulative incidence of local recurrence

    Measured: 5 years

  4. Cumulative incidence of axillary recurrences

    Cumulative incidence of axillary recurrences

    Measured: 5 years

  5. Cumulative incidence of distant recurrences

    Cumulative incidence of distant recurrences

    Measured: 5 years

  6. Disease free survival

    Disease free survival

    Measured: 5 years

  7. Overall survival

    Overall survival

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2018
  2. Study start31 Mar 2017
  3. Primary completion1 Feb 2026
  4. Study completion1 Feb 2026

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03440398
Sponsor's protocol ID
R 530/16- IEO 562
Status last verified
Mar 2026
First submitted
11 Mar 2017
Last updated
24 Mar 2026
Results posted
No
Data monitoring committee
No
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 27810700

  • Toesca A, Peradze N, Manconi A, Nevola Teixeira LF. Reply to the letter to the editor "Robotic-assisted Nipple Sparing Mastectomy: A feasibility study on cadaveric models" by Sarfati B. et al. J Plast Reconstr Aesthet Surg. 2017 Apr;70(4):558-560. doi: 10.1016/j.bjps.2016.12.022. Epub 2017 Jan 23. No abstract available.

    PubMed 28153430

  • Toesca A, Peradze N, Galimberti V, Manconi A, Intra M, Gentilini O, Sances D, Negri D, Veronesi G, Rietjens M, Zurrida S, Luini A, Veronesi U, Veronesi P. Robotic Nipple-sparing Mastectomy and Immediate Breast Reconstruction With Implant: First Report of Surgical Technique. Ann Surg. 2017 Aug;266(2):e28-e30. doi: 10.1097/SLA.0000000000001397. No abstract available.

    PubMed 28692558

  • Toesca A, Sangalli C, Maisonneuve P, Massari G, Girardi A, Baker JL, Lissidini G, Invento A, Farante G, Corso G, Rietjens M, Peradze N, Gottardi A, Magnoni F, Bottiglieri L, Lazzeroni M, Montagna E, Labo P, Orecchia R, Galimberti V, Intra M, Sacchini V, Veronesi P. A Randomized Trial of Robotic Mastectomy Versus Open Surgery in Women With Breast Cancer or BrCA Mutation. Ann Surg. 2022 Jul 1;276(1):11-19. doi: 10.1097/SLA.0000000000004969. Epub 2021 Jun 9.

    PubMed 34597010

Questions about this trial

What is this clinical trial studying?

A study testing Robotic NSM and Open NSM in people with Breast Cancer, 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 11 inclusion and 9 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: finished, as of the sponsor's last update on 24 Mar 2026. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Patient satisfaction (time frame: 1 year). 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 NCT03440398, which also lists 4 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 24 Mar 2026.

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Clinical Trial NCT03440398 | AzTrials