EvoLution of Neoadjuvant TreatMent in 'Triple-negative' or 'HER-2-positive' Breast Cancer Diagnosed in the EaRly Phase
Recruiting · NCT06894173 · Observational (researchers observe without assigning treatment) · Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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
Where it is running
29 locations listed.
- AOU Ospedali Riuniti Torrette di Ancona - Ancona, Italy
- A.O.R.N. "San Giuseppe Moscati" - Avellino, Italy
- Presidio di Brindisi Di Summa - Perrino - Brindisi, Italy
- Humanitas Istituto Clinico Catanese - Catania, Italy
- Azienda Ospedaliera Universitaria "San Martino" - Istituto Nazionale per la Ricerca sul Cancro - Genova, Italy
- ASST - Azienda Ospedaliera Carlo Poma di Mantova - Mantua, Italy
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l. - Meldola, Italy
- Istituto Europeo di Oncologia - Milan, Italy
- ASST - Ospedale Sacco - Milan, Italy
- Azienda Ospedaliera Universitaria - P.O. di Modena - Modena, Italy
- Azienda Ospedaliera "A. Cardarelli" - Naples, Italy
- Istituto Nazionale Tumori di Napoli - IRCCS Istituto Pascale - 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
- Nuovo Ospedale di Prato - S. Stefano - Prato, Italy
- Azienda Ospedaliera San Camillo Forlanini - Roma, Italy
- AOU Policlinico Umberto I - Roma, Italy
- Ospedale Sandro Pertini - ASL Roma 2 - Roma, Italy
- Fondazione Policlinico A. Gemelli, IRCCS - Roma, Italy
- Fondazione Policlinico Universitario A. Gemelli IRCCS - Roma, Italy
- Fondazione Policlinico Universitario A. Gemelli - 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
- Ospedale di Belcolle - Viterbo - Viterbo, Italy
- IRCCS - Centro di Riferimento Oncologico (C.R.O.) di Aviano - Aviano, PN, Italy