Actively Recruiting
EvoLution of Neoadjuvant TreatMent in 'Triple-negative' or 'HER-2-positive' Breast Cancer Diagnosed in the EaRly Phase
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-03-25
1000
Participants Needed
29
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
EvoLution of Neoadjuvant TreatMent in 'Triple-negative' or 'HER-2-positive' Breast Cancer Diagnosed in the EaRly Phase
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological diagnosis of infiltrating breast cancer confirmed by breast and/or axillary node biopsy
- Age 18 years or older at disease onset
- Early disease stage I, II, or III without secondary lesions
- Known status of ER, PgR, HER-2, and Ki67
- Underwent neoadjuvant treatment between 01/01/2016 and 01/01/2021
You will not qualify if you...
- Presence of distant disease at diagnosis or within 3 months after breast surgery
- Prior exposure to neoadjuvant hormonal treatment
- Previous diagnosis of primary breast cancer or a second primary tumor from a different organ
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 29 locations
1
IRCCS - Centro di Riferimento Oncologico (C.R.O.) di Aviano
Aviano, PN, Italy, 33081
Active, Not Recruiting
2
AOU Ospedali Riuniti Torrette di Ancona
Ancona, Italy, 60126
Not Yet Recruiting
3
A.O.R.N. "San Giuseppe Moscati"
Avellino, Italy, 83100
Actively Recruiting
4
Presidio di Brindisi Di Summa - Perrino
Brindisi, Italy, 72100
Not Yet Recruiting
5
Humanitas Istituto Clinico Catanese
Catania, Italy, 95045
Not Yet Recruiting
6
Azienda Ospedaliera Universitaria "San Martino" - Istituto Nazionale per la Ricerca sul Cancro
Genova, Italy, 16132
Not Yet Recruiting
7
ASST - Azienda Ospedaliera Carlo Poma di Mantova
Mantua, Italy, 46100
Actively Recruiting
8
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.
Meldola, Italy, 47014
Actively Recruiting
9
Istituto Europeo di Oncologia
Milan, Italy, 20141
Not Yet Recruiting
10
ASST - Ospedale Sacco
Milan, Italy, 20157
Not Yet Recruiting
11
Azienda Ospedaliera Universitaria - P.O. di Modena
Modena, Italy, 41124
Not Yet Recruiting
12
Azienda Ospedaliera "A. Cardarelli"
Naples, Italy, 80131
Active, Not Recruiting
13
Istituto Nazionale Tumori di Napoli - IRCCS Istituto Pascale
Naples, Italy, 80131
Actively Recruiting
14
Universita' degli Studi di Napoli Federico II
Naples, Italy, 80131
Not Yet Recruiting
15
Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
Novara, Italy, 28100
Not Yet Recruiting
16
Azienda Ospedaliero-Universitaria di Parma
Parma, Italy, 43126
Not Yet Recruiting
17
Azienda Ospedaliera Regionale San Carlo
Potenza, Italy, 85100
Not Yet Recruiting
18
Nuovo Ospedale di Prato - S. Stefano
Prato, Italy, 59100
Actively Recruiting
19
Azienda Ospedaliera San Camillo Forlanini
Roma, Italy, 00152
Active, Not Recruiting
20
AOU Policlinico Umberto I
Roma, Italy, 00155
Not Yet Recruiting
21
Ospedale Sandro Pertini - ASL Roma 2
Roma, Italy, 00155
Not Yet Recruiting
22
Fondazione Policlinico A. Gemelli, IRCCS
Roma, Italy, 00168
Actively Recruiting
23
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy, 00168
Actively Recruiting
24
Fondazione Policlinico Universitario A. Gemelli
Roma, Italy, 00168
Actively Recruiting
25
Arcispedale di Santo Spirito in Sassia - Nuovo Regina Margherita
Roma, Italy, 00193
Not Yet Recruiting
26
Azienda Socio Sanitaria Territoriale ( ASST ) della Valtellina e Alto Lario Presidio di Sondalo
Sondalo, Italy, 23035
Not Yet Recruiting
27
A.O.U. Città della salute e della scienza - Presidio Molinette
Torino, Italy, 10126
Not Yet Recruiting
28
APSS - Ospedale Santa Chiara di Trento
Trento, Italy, 38122
Not Yet Recruiting
29
Ospedale di Belcolle - Viterbo
Viterbo, Italy, 01100
Not Yet Recruiting
Research Team
A
Alessandra Fabi, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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