NCT06894173

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: Retrospective Multicentre Study on the Therapeutic Approach Most Commonly Adopted in the Italian Oncology Centres

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Timeline

• Start date: 2022-12-03
• Primary completion: 2025-12-03
• Completion: 2026-12-03
• First posted: 2025-03-25
• Last updated: 2025-03-25

Locations

29 sites across 1 country: Italy