RecruitingNCT06894173

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

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


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

1,000 participants

Start Date

Dec 3, 2022

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is a historical review of patients with early-stage HER2-positive or triple-negative breast cancer who received chemotherapy before surgery (called neoadjuvant treatment) between 2016 and 2021. The goal is to understand how treatment patterns and outcomes have evolved over time at participating hospitals. **You may be eligible if...** - Your records are from 2016–2021 at a participating hospital - You had early-stage breast cancer (stage I, II, or III) with HER2-positive or triple-negative status - You received chemotherapy before surgery (neoadjuvant treatment) - Your pathology report confirmed invasive breast cancer **You may NOT be eligible if...** - Your cancer had already spread to distant organs at diagnosis or within 3 months of surgery - You received hormonal treatment before surgery - Your cancer subtype or hormone receptor status was not documented Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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NCT06894173


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