EvoLution of Neoadjuvant TreatMent in 'Triple-negative' or 'HER-2-positive' Breast Cancer Diagnosed in the EaRly Phase
NCT ID: NCT06894173
Last Updated: 2025-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2022-12-03
2026-12-03
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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OTHER
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* Prior neoadjuvant hormonal treatment exposure;
* Prior diagnosis of primary breast cancer or second primitive tumour starting from different organ
18 Years
ALL
No
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Principal Investigators
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Alessandra Fabi
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico Universitario A.Gemelli IRCCS, UOC Senologia
Antonella Palazzo
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico Universitario A.Gemelli IRCCS, UOC Oncologia Medica
Locations
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IRCCS - Centro di Riferimento Oncologico (C.R.O.) di Aviano
Aviano, PN, 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
Mantova, , 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"
Napoli, , Italy
Istituto Nazionale Tumori di Napoli - IRCCS Istituto Pascale
Napoli, , Italy
Universita' degli Studi di Napoli Federico II
Napoli, , 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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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4946
Identifier Type: -
Identifier Source: org_study_id
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