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

Status: Recruiting
Location: See all (29) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• For primary endpoint assessment we calculated the percentage of HER2 positive and Triple Negative patients who underwent neoadjuvant treatment in the past 5 years in each site. For this aim all patients with early breast cancer diagnosis who underwent neoadjuvant treatment during the study time, ranging from 01/01/2016 to 01/01/2021, will be included if they had:

• Histological diagnosis of infiltrating breast cancer performed by breast and/or axillary nodes biopsy;

• Age ≥ 18 years at the time of disease onset;

• Absence of secondary lesions, i.e. initial disease stage I, II or III;

• Known status of ER, PgR, HER-2 and Ki67.

Locations
Other Locations
Italy
AOU Ospedali Riuniti Torrette di Ancona
NOT_YET_RECRUITING
Ancona
A.O.R.N. San Giuseppe Moscati
RECRUITING
Avellino
IRCCS - Centro di Riferimento Oncologico (C.R.O.) di Aviano
ACTIVE_NOT_RECRUITING
Aviano
Presidio di Brindisi Di Summa - Perrino
NOT_YET_RECRUITING
Brindisi
Humanitas Istituto Clinico Catanese
NOT_YET_RECRUITING
Catania
Azienda Ospedaliera Universitaria San Martino - Istituto Nazionale per la Ricerca sul Cancro
NOT_YET_RECRUITING
Genova
ASST - Azienda Ospedaliera Carlo Poma di Mantova
RECRUITING
Mantova
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l.
RECRUITING
Meldola
ASST - Ospedale Sacco
NOT_YET_RECRUITING
Milan
Istituto Europeo di Oncologia
NOT_YET_RECRUITING
Milan
Azienda Ospedaliera Universitaria - P.O. di Modena
NOT_YET_RECRUITING
Modena
Azienda Ospedaliera A. Cardarelli
ACTIVE_NOT_RECRUITING
Napoli
Istituto Nazionale Tumori di Napoli - IRCCS Istituto Pascale
RECRUITING
Napoli
Universita' degli Studi di Napoli Federico II
NOT_YET_RECRUITING
Napoli
Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
NOT_YET_RECRUITING
Novara
Azienda Ospedaliero-Universitaria di Parma
NOT_YET_RECRUITING
Parma
Azienda Ospedaliera Regionale San Carlo
NOT_YET_RECRUITING
Potenza
Nuovo Ospedale di Prato - S. Stefano
RECRUITING
Prato
AOU Policlinico Umberto I
NOT_YET_RECRUITING
Roma
Arcispedale di Santo Spirito in Sassia - Nuovo Regina Margherita
NOT_YET_RECRUITING
Roma
Azienda Ospedaliera San Camillo Forlanini
ACTIVE_NOT_RECRUITING
Roma
Fondazione Policlinico A. Gemelli, IRCCS
RECRUITING
Roma
Fondazione Policlinico Universitario A. Gemelli
RECRUITING
Roma
Fondazione Policlinico Universitario A. Gemelli IRCCS
RECRUITING
Roma
Ospedale Sandro Pertini - ASL Roma 2
NOT_YET_RECRUITING
Roma
Azienda Socio Sanitaria Territoriale ( ASST ) della Valtellina e Alto Lario Presidio di Sondalo
NOT_YET_RECRUITING
Sondalo
A.O.U. Città della salute e della scienza - Presidio Molinette
NOT_YET_RECRUITING
Torino
APSS - Ospedale Santa Chiara di Trento
NOT_YET_RECRUITING
Trento
Ospedale di Belcolle - Viterbo
NOT_YET_RECRUITING
Viterbo
Contact Information
Primary
Alessandra Fabi, MD
alessandra.fabi@policlinicogemelli.it
0630157337
Time Frame
Start Date: 2022-12-03
Estimated Completion Date: 2026-12-03
Participants
Target number of participants: 1000
Related Therapeutic Areas
Sponsors
Leads: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

This content was sourced from clinicaltrials.gov