GIM28-ELMER - 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.

Studio Clinico

Patologia: Neoplasie della mammella

Osservazionale-Sperimentale: Osservazionale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: Non applicabile

Linee di trattamento: Adiuvante/neoadiuvante

Criteri di inclusione: 

- 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.

Criteri di esclusione: 

- 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.

Trattamento sperimentale: 

NA

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

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.

Obiettivi secondari dello studio: 

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.

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: NCT06894173

Data di inserimento: 08.07.2025

Promotore

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Principal Investigator ITALIA

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Riferimento: Prof.ssa Alessandra Fabi

Telefono: 0630151

Email: alessandra.fabi@policlinicogemelli.it

Localita: Roma