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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Breast Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Percentage of patients with HER2-positive and Triple Negative tumour among early breast cancer who underwent neoadjuvant treatment

The primary endpoint will express as the ratio between the total number of patients with HER2-positive and TN tumour who underwent neoadjuvant treatment out of total number of patients who had early breast cancer diagnosis and who underwent neoadjuvant treatment during the entire study time, regardless molecular subtype. The primary endpoint will be calculated according molecular subtypes, as follow specified: 'Luminal a and b', 'Triple Negative', 'HER-2 enriched' and 'HER-2 luminal'. The molecular subtypes will be identified and classified according to the 2018 American Society of Clinical Oncology and College of American Pathologists (ASCO-CAP) definition.

Time frame: 5 years

Secondary Outcomes

The frequency of different treatments used in neoadjuvant setting according to initial staging and molecular subtypes;

HER-2 positive and Triple Negative patients subtypes.

Time frame: 5 years

The frequency of different clinical and pathological tumour characteristics according to initial staging and molecular subtypes;