Actively Recruiting

Age: 18Years +
All Genders
NCT06894173

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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