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RECRUITING
NCT06894173

EvoLution of Neoadjuvant TreatMent in 'Triple-negative' or 'HER-2-positive' Breast Cancer Diagnosed in the EaRly Phase

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

Summary

The primary objective of this study is to describe the percentage of patients with HER2-positive and Triple Negative tumour underwent neoadjuvant treatment in clinical practice during the past 5 years out of total number of patients who underwent neoadjuvant treatment, regardless molecular subtypes. Secondary objectives The secondary objectives which are limited to molecular subtypes of study interest, HER2-positive and Triple Negative tumours, are follow reported: * To perform a descriptive analysis on neoadjuvant treatment choice according to molecular subtype and initial staging; * To perform a descriptive analysis on clinical and tumour pathological characteristics according to molecular subtypes and initial staging; * To perform radiological response descriptive analysis achieved with neoadjuvant therapy according to treatment and instrumental examination type (for example: breast MRI, breast ultrasound or mammography); * To perform a descriptive analysis of surgical procedures for both, the breast and the axilla, according to radiological tumour response, initial staging and molecular subtypes; * To perform a descriptive analysis on therapies performed in adjuvant setting according to neoadjuvant treatment type, initial staging and molecular subtypes; * To describe and to analyse the eligibility criteria evolution in neoadjuvant treatment setting during the last 5 years; * To perform a descriptive analysis on pathological complete response (cPR) according to neoadjuvant treatment, molecular subtypes and initial staging; * To evaluate disease-free survival (DFS) according to pCR and molecular subtypes; * To evaluate overall survival (OS) according to pCR and molecular subtypes.

Official title: EvoLution of Neoadjuvant TreatMent in 'Triple-negative' or 'HER-2-positive' Breast Cancer Diagnosed in the EaRly Phase: Retrospective Multicentre Study on the Therapeutic Approach Most Commonly Adopted in the Italian Oncology Centres

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2022-12-03

Completion Date

2026-12-03

Last Updated

2025-03-25

Healthy Volunteers

No

Conditions

Locations (29)

IRCCS - Centro di Riferimento Oncologico (C.R.O.) di Aviano

Aviano, PN, Italy

AOU Ospedali Riuniti Torrette di Ancona

Ancona, Italy

A.O.R.N. "San Giuseppe Moscati"

Avellino, Italy

Presidio di Brindisi Di Summa - Perrino

Brindisi, Italy

Humanitas Istituto Clinico Catanese

Catania, Italy

Azienda Ospedaliera Universitaria "San Martino" - Istituto Nazionale per la Ricerca sul Cancro

Genova, Italy

ASST - Azienda Ospedaliera Carlo Poma di Mantova

Mantua, Italy

Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.

Meldola, Italy

Istituto Europeo di Oncologia

Milan, Italy

ASST - Ospedale Sacco

Milan, Italy

Azienda Ospedaliera Universitaria - P.O. di Modena

Modena, Italy

Azienda Ospedaliera "A. Cardarelli"

Naples, Italy

Istituto Nazionale Tumori di Napoli - IRCCS Istituto Pascale

Naples, Italy

Universita' degli Studi di Napoli Federico II

Naples, Italy

Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

Novara, Italy

Azienda Ospedaliero-Universitaria di Parma

Parma, Italy

Azienda Ospedaliera Regionale San Carlo

Potenza, Italy

Nuovo Ospedale di Prato - S. Stefano

Prato, Italy

Azienda Ospedaliera San Camillo Forlanini

Roma, Italy

AOU Policlinico Umberto I

Roma, Italy

Ospedale Sandro Pertini - ASL Roma 2

Roma, Italy

Fondazione Policlinico A. Gemelli, IRCCS

Roma, Italy

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, Italy

Fondazione Policlinico Universitario A. Gemelli

Roma, Italy

Arcispedale di Santo Spirito in Sassia - Nuovo Regina Margherita

Roma, Italy

Azienda Socio Sanitaria Territoriale ( ASST ) della Valtellina e Alto Lario Presidio di Sondalo

Sondalo, Italy

A.O.U. Città della salute e della scienza - Presidio Molinette

Torino, Italy

APSS - Ospedale Santa Chiara di Trento

Trento, Italy

Ospedale di Belcolle - Viterbo

Viterbo, Italy