NCT06860217

Brief 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 outcome.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
72mo left

Started Apr 2025

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Apr 2025Apr 2032

First Submitted

Initial submission to the registry

January 20, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 5, 2025

Completed
27 days until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2032

Last Updated

March 5, 2025

Status Verified

January 1, 2025

Enrollment Period

7 years

First QC Date

January 20, 2025

Last Update Submit

February 28, 2025

Conditions

Breast CancerDCISBRCA Mutation

Keywords

Robotic MastectomyNipple-sparing mastectomyBreast reconstruction

Outcome Measures

Primary Outcomes (7)

  • Surgery time

    Evaluation of average length of robotic procedure

    1 month

  • Post operative complications

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

    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)

    1 month

  • Length of stay of patients

    Evaluation of average length of stay of patients

    1 month

  • Patient quality of life after surgery

    Completion of BREAST-Q questionnaire (higher answers to each item reflect a better outcome)

    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)

    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)

    5 years

Secondary Outcomes (5)

  • Cumulative incidence of local recurrence

    5 years

  • Cumulative incidence of axillary recurrences

    5 years

  • Cumulative incidence of distant recurrences

    5 years

  • Disease-free survival (DFS)

    5 years

  • Overall survival (OS)

    5 years

Study Arms (1)

Robotic Nipple-Sparing Mastectomy

EXPERIMENTAL

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

Other: Robotic Nipple-Sparing Mastectomy

Interventions

Robotic Nipple-Sparing MastectomyOTHER

Patient will undergo to nipple sparing mastectomy and breast reconstruction, conducted using robot

Robotic Nipple-Sparing Mastectomy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • No hard smoking (defined as \<=20 cigarettes/day)
  • Low and intermediate risk for anesthesia (American Society of Anesthesiologists (ASA) Scale)
  • Patients must be accessible for follow-up

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European Institute of Oncology

Milan, 20141, Italy

Location

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeBreast Carcinoma In SituCarcinoma in SituNeoplasms, Ductal, Lobular, and Medullary

Study Officials

  • Paolo Veronesi, MD

    European Istitute of Oncology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paolo Veronesi, MD

CONTACT

+39 0294371091paolo.veronesi@ieo.it

Mara Negri

CONTACT

+39 0257489536mara.negri@ieo.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Single center prospective trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2025

First Posted

March 5, 2025

Study Start

April 1, 2025

Primary Completion (Estimated)

April 1, 2032

Study Completion (Estimated)

April 1, 2032

Last Updated

March 5, 2025

Record last verified: 2025-01

Locations

IT(1)