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

Recruiting now

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT06894173

Run by

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

People needed

1000

Starts

2022-12-03

Expected to finish

2026-12-03

Last updated by the study team

2025-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Fondazione Policlinico A. Gemelli, IRCCS — Roma, Italy (enrolling)
• Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma, Italy (enrolling)
• Fondazione Policlinico Universitario A. Gemelli — Roma, Italy (enrolling)
• Istituto Nazionale Tumori di Napoli - IRCCS Istituto Pascale — Naples, Italy (enrolling)
• Nuovo Ospedale di Prato - S. Stefano — Prato, Italy (enrolling)
• ASST - Azienda Ospedaliera Carlo Poma di Mantova — Mantua, Italy (enrolling)
• Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l. — Meldola, Italy (enrolling)
• A.O.R.N. "San Giuseppe Moscati" — Avellino, Italy (enrolling)
• Azienda Ospedaliera "A. Cardarelli" — Naples, Italy
• Universita' degli Studi di Napoli Federico II — Naples, Italy
• Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara — Novara, Italy
• Azienda Ospedaliero-Universitaria di Parma — Parma, Italy
• Azienda Ospedaliera Regionale San Carlo — Potenza, Italy
• Azienda Ospedaliera San Camillo Forlanini — Roma, Italy
• AOU Policlinico Umberto I — Roma, Italy
• Ospedale Sandro Pertini - ASL Roma 2 — Roma, Italy
• Arcispedale di Santo Spirito in Sassia - Nuovo Regina Margherita — Roma, Italy
• Azienda Socio Sanitaria Territoriale ( ASST ) della Valtellina e Alto Lario Presidio di Sondalo — Sondalo, Italy
• A.O.U. Città della salute e della scienza - Presidio Molinette — Torino, Italy
• APSS - Ospedale Santa Chiara di Trento — Trento, Italy
• IRCCS - Centro di Riferimento Oncologico (C.R.O.) di Aviano — Aviano, PN, Italy
• Ospedale di Belcolle - Viterbo — Viterbo, Italy
• AOU Ospedali Riuniti Torrette di Ancona — Ancona, Italy
• Presidio di Brindisi Di Summa - Perrino — Brindisi, Italy
• Humanitas Istituto Clinico Catanese — Catania, Italy

Full record on ClinicalTrials.gov

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