EvoLution of Neoadjuvant TreatMent in 'Triple-negative' or 'HER-2-positive' Breast Cancer Diagnosed in the EaRly Phase (GIM28-ELMER)

March 18, 2025 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Ancona, Italy, 60126
      • Avellino, Italy, 83100
        • Recruiting
        • A.O.R.N. "San Giuseppe Moscati"
        • Contact:
      • Brindisi, Italy, 72100
        • Not yet recruiting
        • Presidio di Brindisi Di Summa - Perrino
        • Contact:
      • Catania, Italy, 95045
      • Genova, Italy, 16132
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria "San Martino" - Istituto Nazionale per la Ricerca sul Cancro
        • Contact:
      • Mantova, Italy, 46100
      • Meldola, Italy, 47014
        • Recruiting
        • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.
        • Contact:
      • Milano, Italy, 20141
        • Not yet recruiting
        • Istituto Europeo di Oncologia
        • Contact:
      • Milano, Italy, 20157
      • Modena, Italy, 41124
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria - P.O. di Modena
        • Contact:
      • Napoli, Italy, 80131
        • Active, not recruiting
        • Azienda Ospedaliera "A. Cardarelli"
      • Napoli, Italy, 80131
        • Recruiting
        • Istituto Nazionale Tumori di Napoli - IRCCS Istituto Pascale
        • Contact:
      • Napoli, Italy, 80131
        • Not yet recruiting
        • Universita' degli Studi di Napoli Federico II
        • Contact:
      • Novara, Italy, 28100
      • Parma, Italy, 43126
        • Not yet recruiting
        • Azienda Ospedaliero-Universitaria di Parma
        • Contact:
      • Potenza, Italy, 85100
      • Prato, Italy, 59100
      • Roma, Italy, 00168
      • Roma, Italy, 00168
      • Roma, Italy, 00152
        • Active, not recruiting
        • Azienda Ospedaliera San Camillo Forlanini
      • Roma, Italy, 00155
      • Roma, Italy, 00155
      • Roma, Italy, 00168
      • Roma, Italy, 00193
        • Not yet recruiting
        • Arcispedale di Santo Spirito in Sassia - Nuovo Regina Margherita
        • Contact:
      • Sondalo, Italy, 23035
        • Not yet recruiting
        • Azienda Socio Sanitaria Territoriale ( ASST ) della Valtellina e Alto Lario Presidio di Sondalo
        • Contact:
      • Torino, Italy, 10126
        • Not yet recruiting
        • A.O.U. Città della salute e della scienza - Presidio Molinette
        • Contact:
      • Trento, Italy, 38122
        • Not yet recruiting
        • APSS - Ospedale Santa Chiara di Trento
        • Contact:
      • Viterbo, Italy, 01100
        • Not yet recruiting
        • Ospedale di Belcolle - Viterbo
        • Contact:
    • PN
      • Aviano, PN, Italy, 33081
        • Active, not recruiting
        • IRCCS - Centro di Riferimento Oncologico (C.R.O.) di Aviano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with HER2-positive and Triple Negative tumour among early breast cancer who underwent neoadjuvant treatment
Time Frame: 5 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The frequency of different treatments used in neoadjuvant setting according to initial staging and molecular subtypes;
Time Frame: 5 years
HER-2 positive and Triple Negative patients subtypes.
5 years
The frequency of different clinical and pathological tumour characteristics according to initial staging and molecular subtypes;
Time Frame: 5 years
HER-2 positive and Triple Negative patients
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
HER-2 positive and Triple Negative patients
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
HER-2 positive and Triple Negative patients
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
HER-2 positive and Triple Negative patients
5 years
The frequency of pathologic complete response (pCR) according to molecular subtypes and neoadjuvant treatment;
Time Frame: 5 years
HER-2 positive and Triple Negative patients
5 years
Descriptive analysis of the correlation between complete radiologic response and pCR according to molecular subtypes and neoadjuvant treatment.
Time Frame: 5 years
HER-2 positive and Triple Negative patients
5 years
Descriptive analysis of the correlation between pCR and DFS according to the different molecular subtypes.
Time Frame: 5 years
HER-2 positive and Triple Negative patients. DFS will be calculated as time interval from the date of first neoadjuvant cycle to the date of onset disease recurrence at local, contralateral or at distance level. For patients without recurrence at the time of DFS analysis, the second date will be censored at the time of last control.
5 years
Correlation analysis between pCR and OS according to the different molecular subtypes.
Time Frame: 5 years
HER-2 positive and Triple Negative patients.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Alessandra Fabi, Fondazione Policlinico Universitario A.Gemelli IRCCS, UOC Senologia
  • Principal Investigator: Antonella Palazzo, Fondazione Policlinico Universitario A.Gemelli IRCCS, UOC Oncologia Medica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2022

Primary Completion (Estimated)

December 3, 2025

Study Completion (Estimated)

December 3, 2026

Study Registration Dates

First Submitted

March 12, 2025

First Submitted That Met QC Criteria

March 18, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4946

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

It is not yet known if there will be a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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