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International Prospective REgistry on Pre-pectorAl Breast REconstruction

NCT ID: NCT05817175

Last Updated: 2025-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1236 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-12

Study Completion Date

2027-09-10

Brief Summary

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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.

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Detailed Description

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1,236 patients undergoing mastectomy for breast cancer and subsequent pre-pectoral breast reconstruction will be enrolled. Being an observational study, the diagnostic-therapeutic path of the patients will not be modified in any way. Therefore, no risks are anticipated for the patients who will participate in this study. Potential benefits deriving from the study will be for future patients for whom good quality data will be available which can guide the choice of the type of breast reconstruction to be performed, in particular the most appropriate type of technique in the pre-pectoral approach.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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pre-pectoral breast reconstruction

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Male patients
* Patients not suitable for surgical treatment
* Patients undergoing subpectoral reconstruction
* Patients undergoing breast reconstruction with autologous tissue.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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EUBREAST ETS

UNKNOWN

Sponsor Role collaborator

IRCCS San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Oreste Davide Gentilini

Professor, Head of Breast Surgery Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oreste D Gentilini, Dr

Role: STUDY_CHAIR

IRCCS San Raffaele

Locations

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Univesidad de Buenos Aires

Buenos Aires, , Argentina

Site Status RECRUITING

Mansoura Insurance

Al Mansurah, , Egypt

Site Status RECRUITING

Mansoura Oncology

Al Mansurah, , Egypt

Site Status RECRUITING

National ans Kapodistrian University of Athens

Athens, , Greece

Site Status RECRUITING

Ospedale San Raffaele

Milan, MI, Italy

Site Status RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli

Roma, RM, Italy

Site Status RECRUITING

University Hospital of Karol Marcinkowski

Zielona Góra, , Poland

Site Status RECRUITING

Prof. Dr. Ion Chiricuta Institute of Oncology

Cluj-Napoca, , Romania

Site Status RECRUITING

Hospital del Mar

Barcelona, , Spain

Site Status RECRUITING

Marmara University School of medicine

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

University Hospitals of Leicester

Leicester, , United Kingdom

Site Status RECRUITING

Countries

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Argentina Egypt Greece Italy Poland Romania Spain Turkey (Türkiye) United Kingdom

Central Contacts

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Oreste D Gentilini, Dr

Role: CONTACT

[email protected]
+390226431 ext. 3939

Rosa Di Micco, Dr

Role: CONTACT

[email protected]
+390226431 ext. 4565

Facility Contacts

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Eduardo Gonzalez, MD

Role: primary

Khaled Ali

Role: primary

Khaled Ali, MD

Role: primary

Michalis Kontos, MD

Role: primary

ORESTE DAVIDE GENTILINI, MD

Role: primary

[email protected]

Gianluca Franceschini, MD

Role: primary

Dawid Murawa

Role: primary

Maximilian Muntean, MD

Role: primary

Maria Del Mar Bernet-Tomas, MD

Role: primary

Umit Ugurlu, MD

Role: primary

Tim Rattay

Role: primary

Other Identifiers

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EUBREAST-11R

Identifier Type: -

Identifier Source: org_study_id

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