MedTrace Logo

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

NCT06894173 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2025-03-25

No results posted yet for this study

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

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Alessandra Fabi · Fondazione Policlinico Universitario A.Gemelli IRCCS, UOC Senologia

  • Antonella Palazzo · Fondazione Policlinico Universitario A.Gemelli IRCCS, UOC Oncologia Medica

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-03
Primary Completion
2025-12-03
Completion
2026-12-03

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06894173 on ClinicalTrials.gov