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

Last updated: March 18, 2025
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT06894173
4946
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • For primary endpoint assessment we calculated the percentage of HER2 positive andTriple Negative patients who underwent neoadjuvant treatment in the past 5 years ineach site. For this aim all patients with early breast cancer diagnosis whounderwent 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/oraxillary 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

Exclusion Criteria:

  • Documented distant disease at onset diagnosis or within 3 months from breastsurgery;

  • Prior neoadjuvant hormonal treatment exposure;

  • Prior diagnosis of primary breast cancer or second primitive tumour starting fromdifferent organ

Study Design

Total Participants: 1000
Study Start date:
December 03, 2022
Estimated Completion Date:
December 03, 2026

Connect with a study center

  • IRCCS - Centro di Riferimento Oncologico (C.R.O.) di Aviano

    Aviano, PN 33081
    Italy

    Site Not Available

  • AOU Ospedali Riuniti Torrette di Ancona

    Ancona, 60126
    Italy

    Site Not Available

  • A.O.R.N. "San Giuseppe Moscati"

    Avellino, 83100
    Italy

    Active - Recruiting

  • Presidio di Brindisi Di Summa - Perrino

    Brindisi, 72100
    Italy

    Site Not Available

  • Humanitas Istituto Clinico Catanese

    Catania, 95045
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria "San Martino" - Istituto Nazionale per la Ricerca sul Cancro

    Genova, 16132
    Italy

    Site Not Available

  • ASST - Azienda Ospedaliera Carlo Poma di Mantova

    Mantova, 46100
    Italy

    Active - Recruiting

  • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.

    Meldola, 47014
    Italy

    Active - Recruiting

  • ASST - Ospedale Sacco

    Milano, 20157
    Italy

    Site Not Available

  • Istituto Europeo di Oncologia

    Milano, 20141
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria - P.O. di Modena

    Modena, 41124
    Italy

    Site Not Available

  • Azienda Ospedaliera "A. Cardarelli"

    Napoli, 80131
    Italy

    Site Not Available

  • Istituto Nazionale Tumori di Napoli - IRCCS Istituto Pascale

    Napoli, 80131
    Italy

    Active - Recruiting

  • Universita' degli Studi di Napoli Federico II

    Napoli, 80131
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

    Novara, 28100
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria di Parma

    Parma, 43126
    Italy

    Site Not Available

  • Azienda Ospedaliera Regionale San Carlo

    Potenza, 85100
    Italy

    Site Not Available

  • Nuovo Ospedale di Prato - S. Stefano

    Prato, 59100
    Italy

    Active - Recruiting

  • AOU Policlinico Umberto I

    Roma, 00155
    Italy

    Site Not Available

  • Arcispedale di Santo Spirito in Sassia - Nuovo Regina Margherita

    Roma, 00193
    Italy

    Site Not Available

  • Azienda Ospedaliera San Camillo Forlanini

    Roma, 00152
    Italy

    Site Not Available

  • Fondazione Policlinico A. Gemelli, IRCCS

    Roma, 00168
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario A. Gemelli

    Roma, 00168
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    Roma, 00168
    Italy

    Active - Recruiting

  • Ospedale Sandro Pertini - ASL Roma 2

    Roma, 00155
    Italy

    Site Not Available

  • Azienda Socio Sanitaria Territoriale ( ASST ) della Valtellina e Alto Lario Presidio di Sondalo

    Sondalo, 23035
    Italy

    Site Not Available

  • A.O.U. Città della salute e della scienza - Presidio Molinette

    Torino, 10126
    Italy

    Site Not Available

  • APSS - Ospedale Santa Chiara di Trento

    Trento, 38122
    Italy

    Site Not Available

  • Ospedale di Belcolle - Viterbo

    Viterbo, 01100
    Italy

    Site Not Available

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