Clinical trial NCT06894173: EvoLution of Neoadjuvant TreatMent in 'Triple-negative' or 'HER-2-positive' Breast Cancer Diagnosed in the EaRly Phase
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients eligible for this retrospective, non-interventional study, must have been exposed to neoadjuvant chemotherapy with or without target therapies in the 5-year period from 01/01/2016 to 01/01/2021

Brief 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 criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Documented distant disease at onset diagnosis or within 3 months from breast surgery;
* Prior neoadjuvant hormonal treatment exposure;
* Prior diagnosis of primary breast cancer or second primitive tumour starting from different organ

Primary outcomes:
measure: Percentage of patients with HER2-positive and Triple Negative tumour among early breast cancer who underwent neoadjuvant treatment
timeFrame: 5 years
Secondary outcomes:
measure: The frequency of different treatments used in neoadjuvant setting according to initial staging and molecular subtypes;
timeFrame: 5 years
measure: The frequency of different clinical and pathological tumour characteristics according to initial staging and molecular subtypes;
timeFrame: 5 years
measure: The frequency of complete radiological response according to neoadjuvant treatment, instrumental examination (breast MRI, breast ultrasound or mammography) used in clinical practice and molecular subtypes;
timeFrame: 5 years
measure: The frequency of different surgical procedures for both, the breast and the axilla, according to radiological response, initial staging and molecular subtypes;
timeFrame: 5 years
measure: The frequency of different treatments adopted in adjuvant setting according to neoadjuvant treatment type, initial staging and molecular subtypes.
timeFrame: 5 years
measure: The frequency of pathologic complete response (pCR) according to molecular subtypes and neoadjuvant treatment;
timeFrame: 5 years
measure: Descriptive analysis of the correlation between complete radiologic response and pCR according to molecular subtypes and neoadjuvant treatment.
timeFrame: 5 years
measure: Descriptive analysis of the correlation between pCR and DFS according to the different molecular subtypes.
timeFrame: 5 years
measure: Correlation analysis between pCR and OS according to the different molecular subtypes.
timeFrame: 5 years
Other outcomes:
Locations:
city: Aviano
country: Italy
facility: IRCCS - Centro di Riferimento Oncologico (C.R.O.) di Aviano
state: PN
city: Ancona
country: Italy
facility: AOU Ospedali Riuniti Torrette di Ancona
city: Avellino
country: Italy
facility: A.O.R.N. "San Giuseppe Moscati"
city: Brindisi
country: Italy
facility: Presidio di Brindisi Di Summa - Perrino
city: Catania
country: Italy
facility: Humanitas Istituto Clinico Catanese
city: Genova
country: Italy
facility: Azienda Ospedaliera Universitaria "San Martino" - Istituto Nazionale per la Ricerca sul Cancro
city: Mantova
country: Italy
facility: ASST - Azienda Ospedaliera Carlo Poma di Mantova
city: Meldola
country: Italy
facility: Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
city: Milano
country: Italy
facility: ASST - Ospedale Sacco
city: Modena
country: Italy
facility: Azienda Ospedaliera Universitaria - P.O. di Modena
city: Napoli
country: Italy
facility: Azienda Ospedaliera "A. Cardarelli"
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori di Napoli - IRCCS Istituto Pascale
city: Napoli
country: Italy
facility: Universita' degli Studi di Napoli Federico II
city: Novara
country: Italy
facility: Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
city: Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria di Parma
city: Potenza
country: Italy
facility: Azienda Ospedaliera Regionale San Carlo
city: Prato
country: Italy
facility: Nuovo Ospedale di Prato - S. Stefano
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
city: Roma
country: Italy
facility: AOU Policlinico Umberto I
city: Roma
country: Italy
facility: Ospedale Sandro Pertini - ASL Roma 2
city: Roma
country: Italy
facility: Fondazione Policlinico A. Gemelli, IRCCS
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli
city: Roma
country: Italy
facility: Arcispedale di Santo Spirito in Sassia - Nuovo Regina Margherita
city: Sondalo
country: Italy
facility: Azienda Socio Sanitaria Territoriale ( ASST ) della Valtellina e Alto Lario Presidio di Sondalo
city: Torino
country: Italy
facility: A.O.U. Città della salute e della scienza - Presidio Molinette
city: Trento
country: Italy
facility: APSS - Ospedale Santa Chiara di Trento
city: Viterbo
country: Italy
facility: Ospedale di Belcolle - Viterbo
Study officials:
affiliation: Fondazione Policlinico Universitario A.Gemelli IRCCS, UOC Senologia
name: Alessandra Fabi
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione Policlinico Universitario A.Gemelli IRCCS, UOC Oncologia Medica
name: Antonella Palazzo
role: PRINCIPAL_INVESTIGATOR
References: