EvoLution of Neoadjuvant TreatMent in 'Triple-negative' or 'HER-2-positive' Breast Cancer Diagnosed in the EaRly Phase (GIM28-ELMER)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06894173

4946

Details and patient eligibility

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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