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

NCT06894173 | Recruiting

• 1 other identifier: 4946
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 29

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with HER2-positive and Triple Negative tumour among early breast cancer who underwent neoadjuvant treatment

  The primary endpoint will express as the ratio between the total number of patients with HER2-positive and TN tumour who underwent neoadjuvant treatment out of total number of patients who had early breast cancer diagnosis and who underwent neoadjuvant treatment during the entire study time, regardless molecular subtype. The primary endpoint will be calculated according molecular subtypes, as follow specified: 'Luminal a and b', 'Triple Negative', 'HER-2 enriched' and 'HER-2 luminal'. The molecular subtypes will be identified and classified according to the 2018 American Society of Clinical Oncology and College of American Pathologists (ASCO-CAP) definition.

  5 years

Secondary Outcomes (9)

• The frequency of different treatments used in neoadjuvant setting according to initial staging and molecular subtypes;

  5 years

• The frequency of different clinical and pathological tumour characteristics according to initial staging and molecular subtypes;

  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;

  5 years

• The frequency of different surgical procedures for both, the breast and the axilla, according to radiological response, initial staging and molecular subtypes;

  5 years

• The frequency of different treatments adopted in adjuvant setting according to neoadjuvant treatment type, initial staging and molecular subtypes.

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients eligible for this retrospective, non-interventional study, must have been exposed to neoadjuvant chemotherapy with or without target therapies in the 5-year period from 01/01/2016 to 01/01/2021

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (29)

IRCCS - Centro di Riferimento Oncologico (C.R.O.) di Aviano

Aviano, PN, 33081, Italy

ACTIVE NOT RECRUITING

AOU Ospedali Riuniti Torrette di Ancona

Ancona, 60126, Italy

NOT YET RECRUITING

A.O.R.N. "San Giuseppe Moscati"

Avellino, 83100, Italy

RECRUITING

Presidio di Brindisi Di Summa - Perrino

Brindisi, 72100, Italy

NOT YET RECRUITING

Humanitas Istituto Clinico Catanese

Catania, 95045, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria "San Martino" - Istituto Nazionale per la Ricerca sul Cancro

Genova, 16132, Italy

NOT YET RECRUITING

ASST - Azienda Ospedaliera Carlo Poma di Mantova

Mantova, 46100, Italy

RECRUITING

Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.

Meldola, 47014, Italy

RECRUITING

Istituto Europeo di Oncologia

Milan, 20141, Italy

NOT YET RECRUITING

ASST - Ospedale Sacco

Milan, 20157, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria - P.O. di Modena

Modena, 41124, Italy

NOT YET RECRUITING

Azienda Ospedaliera "A. Cardarelli"

Napoli, 80131, Italy

ACTIVE NOT RECRUITING

Istituto Nazionale Tumori di Napoli - IRCCS Istituto Pascale

Napoli, 80131, Italy

RECRUITING

Universita' degli Studi di Napoli Federico II

Napoli, 80131, Italy

NOT YET RECRUITING

Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

Novara, 28100, Italy

NOT YET RECRUITING

Azienda Ospedaliero-Universitaria di Parma

Parma, 43126, Italy

NOT YET RECRUITING

Azienda Ospedaliera Regionale San Carlo

Potenza, 85100, Italy

NOT YET RECRUITING

Nuovo Ospedale di Prato - S. Stefano

Prato, 59100, Italy

RECRUITING

Azienda Ospedaliera San Camillo Forlanini

Roma, 00152, Italy

ACTIVE NOT RECRUITING

AOU Policlinico Umberto I

Roma, 00155, Italy

NOT YET RECRUITING

Ospedale Sandro Pertini - ASL Roma 2

Roma, 00155, Italy

NOT YET RECRUITING

Fondazione Policlinico A. Gemelli, IRCCS

Roma, 00168, Italy

RECRUITING

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

Fondazione Policlinico Universitario A. Gemelli

Roma, 00168, Italy

RECRUITING

Arcispedale di Santo Spirito in Sassia - Nuovo Regina Margherita

Roma, 00193, Italy

NOT YET RECRUITING

Azienda Socio Sanitaria Territoriale ( ASST ) della Valtellina e Alto Lario Presidio di Sondalo

Sondalo, 23035, Italy

NOT YET RECRUITING

A.O.U. Città della salute e della scienza - Presidio Molinette

Torino, 10126, Italy

NOT YET RECRUITING

APSS - Ospedale Santa Chiara di Trento

Trento, 38122, Italy

NOT YET RECRUITING

Ospedale di Belcolle - Viterbo

Viterbo, 01100, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Alessandra Fabi

  Fondazione Policlinico Universitario A.Gemelli IRCCS, UOC Senologia

  PRINCIPAL INVESTIGATOR

• Antonella Palazzo

  Fondazione Policlinico Universitario A.Gemelli IRCCS, UOC Oncologia Medica

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandra Fabi, MD

CONTACT

0630157337; alessandra.fabi@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 25, 2025
• Study Start: December 3, 2022
• Primary Completion: December 3, 2025
• Study Completion (Estimated): December 3, 2026
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

IT (29)