NCT05817175

Brief Summary

This is an international multicenter prospective cohort study aimed at collecting data on breast reconstruction techniques with pre-pectoral implants after mastectomy for breast cancer. The aim of the study is to collect data on the surgical, aesthetic and oncological results, as well as on the quality of life of the patients who will undergo breast reconstruction with a pre-pectoral approach.

Trial Health

83
On Track

Trial Health Score

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

Enrollment
1,236

participants targeted

Target at P75+ for all trials

Timeline
17mo left

Started Sep 2023

Longer than P75 for all trials

Geographic Reach
9 countries

11 active sites

Status
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 Progress66%
Sep 2023Sep 2027

First Submitted

Initial submission to the registry

April 4, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

September 12, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2027

Last Updated

June 4, 2025

Status Verified

June 1, 2025

Enrollment Period

4 years

First QC Date

April 4, 2023

Last Update Submit

June 3, 2025

Conditions

Breast Cancer

Keywords

Breast CancerBreast reconstructionPre-pectoral Breast ProsthesisMastectomy

Outcome Measures

Primary Outcomes (1)

  • Number of patients with Implant-loss at three months postoperatively

    Rate of implant-loss at three months postoperatively defined as the unplanned removal or loss of the implant as a result of infection or other complication

    three months postoperatively

Secondary Outcomes (5)

  • Number of patients with Infection

    three months postoperatively

  • Number of patients with re-admission and re-operation

    three months postoperatively

  • Evaluation of Quality of life

    0, 6, 12 and 24 months

  • Number of Early onset complication

    three months postoperatively

  • Number of late-onset complications

    6-12-24 months

Interventions

pre-pectoral breast reconstructionPROCEDURE

to prospectively evaluate the utilization of the pre-pectoral approach, and evaluate oncological and aesthetic outcomes related to each type of surgical technique and the use of postmastectomy radiation therapy

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale patients older than 18 years old
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who are candidates for implant-based reconstruction should be informed about the possible participation to this clinical study. The inclusion and exclusion criteria are verified by the investigator and an informed consent is obtained from the patient. The therapeutic pattern should be followed according to institutional and national standards. Since this is a non-interventional trial, the study sites do not deviate from their own study protocol at any timepoint.

You may qualify if:

  • Female patients older than 18 years old
  • Signed informed consent form
  • Patients undergoing mono or bilateral therapeutic mastectomy
  • Patients undergoing pre-pectoral implant-based breast reconstruction with implant or expander with or without mesh

You may not qualify if:

  • Male patients
  • Patients not suitable for surgical treatment
  • Patients undergoing subpectoral reconstruction
  • Patients undergoing breast reconstruction with autologous tissue.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Univesidad de Buenos Aires

Buenos Aires, Argentina

RECRUITING

Mansoura Insurance

Al Mansurah, Egypt

RECRUITING

Mansoura Oncology

Al Mansurah, Egypt

RECRUITING

National ans Kapodistrian University of Athens

Athens, Greece

RECRUITING

Ospedale San Raffaele

Milan, MI, 20132, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli

Roma, RM, 00136, Italy

RECRUITING

University Hospital of Karol Marcinkowski

Zielona Góra, Poland

RECRUITING

Prof. Dr. Ion Chiricuta Institute of Oncology

Cluj-Napoca, Romania

RECRUITING

Hospital del Mar

Barcelona, Spain

RECRUITING

Marmara University School of medicine

Istanbul, Turkey (Türkiye)

RECRUITING

University Hospitals of Leicester

Leicester, United Kingdom

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Oreste D Gentilini, Dr

    IRCCS San Raffaele

    STUDY CHAIR

Central Study Contacts

Oreste D Gentilini, Dr

CONTACT

+390226431gentilini@eubreast.com

Rosa Di Micco, Dr

CONTACT

+390226431dimicco.rosa@hsr.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Head of Breast Surgery Unit

Study Record Dates

First Submitted

April 4, 2023

First Posted

April 18, 2023

Study Start

September 12, 2023

Primary Completion (Estimated)

September 10, 2027

Study Completion (Estimated)

September 10, 2027

Last Updated

June 4, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

AR(1)PL(1)ES(1)IT(2)EG(2)GR(1)RO(1)GB(1)TU(1)