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Clinical Trials in Italy / NCT05817175
Recruiting Observational

International Prospective REgistry on Pre-pectorAl Breast REconstruction

NCT05817175 · tracked via the Priya Life Science Italy tracker
Sponsor
European Breast Cancer Research Association of Surgical Trialists
Phase
Observational
Started
2023-09-12
Last updated
2026-09-11

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

pre-pectoral breast reconstruction

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

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

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

Trial sites (11)

FacilityCityRegionStatus
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 Recruiting
Fondazione Policlinico Universitario Agostino Gemelli Roma RM 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

Other trials for the same condition

A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer Recruiting
DianaWeb: Before and After Study Online Based Participatory Research on Breast Cancer Women Recruiting
Axillary Radiotherapy or Axillary Lymph Node Dissection in Patients With Clinically Node- Positive Breast Cancer Undergoing Upfront Tailored Axillary Surgery Recruiting
EvoLution of Neoadjuvant TreatMent in 'Triple-negative' or 'HER-2-positive' Breast Cancer Diagnosed in the EaRly Phase Recruiting
EndoBreast Study - Assessment of Feasibility, Functional Outcomes, and Sensitivity of the Areola-Nipple Complex in Endoscopic Mastectomy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05817175 on ClinicalTrials.gov ↗ ← All trials in Italy