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

Recruitingn/aAges 18 Years - anyAllFondazione Policlinico Universitario Agostino Gem…
NCT06894173 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

29 sites
IRCCS - Centro di Riferimento Oncologico (C.R.O.) di Aviano
Aviano, Italy
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

…and 21 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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