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

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

Recruiting
18 years and older
All
Phase N/A

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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.

Eligibility

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

Study details
    Breast Cancer

NCT06894173

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

15 October 2025

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