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

Official title

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

Overview

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.

Primary outcome measures

• Percentage of patients with HER2-positive and Triple Negative tumour among early breast cancer who underwent neoadjuvant treatment [Time frame: 5 years]

Secondary outcome measures (9)

• The frequency of different treatments used in neoadjuvant setting according to initial staging and molecular subtypes; [Time frame: 5 years]
• The frequency of different clinical and pathological tumour characteristics according to initial staging and molecular subtypes; [Time frame: 5 years]
• The frequency of complete radiological response according to neoadjuvant treatment, instrumental examination (breast MRI, breast ultrasound or mammography) used in clinical practice and molecular subtypes; [Time frame: 5 years]
• The frequency of different surgical procedures for both, the breast and the axilla, according to radiological response, initial staging and molecular subtypes; [Time frame: 5 years]
• The frequency of different treatments adopted in adjuvant setting according to neoadjuvant treatment type, initial staging and molecular subtypes. [Time frame: 5 years]
• The frequency of pathologic complete response (pCR) according to molecular subtypes and neoadjuvant treatment; [Time frame: 5 years]
• Descriptive analysis of the correlation between complete radiologic response and pCR according to molecular subtypes and neoadjuvant treatment. [Time frame: 5 years]
• Descriptive analysis of the correlation between pCR and DFS according to the different molecular subtypes. [Time frame: 5 years]
• Correlation analysis between pCR and OS according to the different molecular subtypes. [Time frame: 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Other

Study locations

Italy · 29 centers

• IRCCS - Centro di Riferimento Oncologico (C.R.O.) di Aviano — Aviano
• AOU Ospedali Riuniti Torrette di Ancona — Ancona
• A.O.R.N. "San Giuseppe Moscati" — Avellino
• Presidio di Brindisi Di Summa - Perrino — Brindisi
• Humanitas Istituto Clinico Catanese — Catania
• Azienda Ospedaliera Universitaria "San Martino" - Istituto Nazionale per la Ricerca sul Ca — Genova
• ASST - Azienda Ospedaliera Carlo Poma di Mantova — Mantua
• Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l. — Meldola
• … and 21 more centers

Identifiers

NCT: NCT06894173 · 4946

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗