Breast CancerGIM28-ELMERNCT06894173
EvoLution of Neoadjuvant TreatMent in 'Triple-negative' or 'HER-2-positive' Breast Cancer Diagnosed in the EaRly Phase
An observational study of Breast Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 29 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 1,000 participants
- Where
- 29 sitesItaly
- Study dates
- 3 Dec 2022to 3 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
29 sites in 1 country. Contact the study team or a site near you to ask about taking part.
29 sites in 1 country
Italy29 sites, 26 recruiting
- Not yet recruiting
AOU Ospedali Riuniti Torrette di Ancona
Ancona, 60126
Rossana Berardi, MD, 071596-5715, r.berardi@univpm.it;rossana.berardi@ospedaliriuniti.marche.it
- Recruiting
A.O.R.N. "San Giuseppe Moscati"
Avellino, 83100
Giuseppe Colantuoni, MD, 0825203946, gicolantuoni@gmail.com
- Active, not recruiting
IRCCS - Centro di Riferimento Oncologico (C.R.O.) di Aviano
Aviano, PN, 33081
- Not yet recruiting
Presidio di Brindisi Di Summa - Perrino
Brindisi, 72100
Laura Orlando, MD, 0831537218, laura.orlando68@gmail.com
- Not yet recruiting
Humanitas Istituto Clinico Catanese
Catania, 95045
Michele Caruso, MD, michele.caruso@ccocatania.it
- Not yet recruiting
Azienda Ospedaliera Universitaria "San Martino" - Istituto Nazionale per la Ricerca sul Cancro
Genova, 16132
Lucia Del Mastro, MD, 010.5558904, lucia.delmastro@hsanmartino.it
- Recruiting
ASST - Azienda Ospedaliera Carlo Poma di Mantova
Mantua, 46100
Giovanna Catania, MD, giovanna.catania@asst-mantova.it
- Recruiting
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.
Meldola, 47014
Michela Palleschi, MD, 0543 739297, michela.palleschi@irst.emr.it
- Not yet recruiting
Istituto Europeo di Oncologia
Milan, 20141
Elisabetta Munzone, MD, 02-57489.502, elisabetta.munzone@ieo.it
- Not yet recruiting
ASST - Ospedale Sacco
Milan, 20157
Nicla La Verde, MD, 02 39042493, nicla.laverde@asst-fbf-sacco.it
- Not yet recruiting
Azienda Ospedaliera Universitaria - P.O. di Modena
Modena, 41124
Luca Moscetti, MD, 0594223244, moscetti.luca@aou.mo.it
- Active, not recruiting
Azienda Ospedaliera "A. Cardarelli"
Naples, 80131
- Recruiting
Istituto Nazionale Tumori di Napoli - IRCCS Istituto Pascale
Naples, 80131
MIchelino De Laurentiis, MD, 081.5903699, m.delaurentiis@istitutotumori.na.it
- Not yet recruiting
Universita' degli Studi di Napoli Federico II
Naples, 80131
Grazia Arpino, MD, 0817463772/7251, grazia.arpino@unina.it
- Not yet recruiting
Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
Novara, 28100
Alessandra Gennari, MD, alessandra.gennari@med.uniupo.it
- Not yet recruiting
Azienda Ospedaliero-Universitaria di Parma
Parma, 43126
Antonino Musolino, MD, 0521702660, amusolino@ao.pr.it
- Not yet recruiting
Azienda Ospedaliera Regionale San Carlo
Potenza, 85100
Domenico Bilancia, MD, 0971613638, domenico.bilancia@ospedalesancarlo.it;domenicobilancia@gmail.com
- Recruiting
Nuovo Ospedale di Prato - S. Stefano
Prato, 59100
Laura Biganzoli, MD, 0574 802528, laura.biganzoli@uslcentro.toscana.it
- Active, not recruiting
Azienda Ospedaliera San Camillo Forlanini
Roma, 00152
- Not yet recruiting
AOU Policlinico Umberto I
Roma, 00155
Andrea Botticelli, MD, andrea.botticelli@uniroma1.it
- Not yet recruiting
Ospedale Sandro Pertini - ASL Roma 2
Roma, 00155
Teresa Gamucci, MD, teresa.gamucci@aslroma2.it
- Recruiting
Fondazione Policlinico A. Gemelli, IRCCS
Roma, 00168
Alessandra Fabi, MD, 0630157337, alessandra.fabi@policlinicogemelli.it
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 00168
Alessandra Fabi, +390630157337, alessandra.fabi@policlinicogemelli.it
Antonella Palazzo, antonella.palazzo@policlinicogemelli.it
- Recruiting
Fondazione Policlinico Universitario A. Gemelli
Roma, 00168
Antonella Palazzo, MD, antonella.palazzo@policlinicogemelli.it
- Not yet recruiting
Arcispedale di Santo Spirito in Sassia - Nuovo Regina Margherita
Roma, 00193
Simonetta Chiara Stani, MD, 0668352073, simonetta.stani@aslroma1.it
- Not yet recruiting
Azienda Socio Sanitaria Territoriale ( ASST ) della Valtellina e Alto Lario Presidio di Sondalo
Sondalo, 23035
Ornella Fusco, MD, ornella.fusco@asst-val.it
- Not yet recruiting
A.O.U. Città della salute e della scienza - Presidio Molinette
Torino, 10126
Alessandra Beano, MD, abeano@cittadellasalute.to.it
- Not yet recruiting
APSS - Ospedale Santa Chiara di Trento
Trento, 38122
Antonella Ferro, MD, 0461903178, antonella.ferro@apss.tn.it
- Not yet recruiting
Ospedale di Belcolle - Viterbo
Viterbo, 01100
Agnese Fabbri, MD, 0761339042 -055, agnese.fabbri@yahoo.it
About this study
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
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
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (9)
The frequency of different treatments used in neoadjuvant setting according to initial staging and molecular subtypes;
HER-2 positive and Triple Negative patients subtypes.
Measured: 5 years
The frequency of different clinical and pathological tumour characteristics according to initial staging and molecular subtypes;
HER-2 positive and Triple Negative patients
Measured: 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;
HER-2 positive and Triple Negative patients
Measured: 5 years
The frequency of different surgical procedures for both, the breast and the axilla, according to radiological response, initial staging and molecular subtypes;
HER-2 positive and Triple Negative patients
Measured: 5 years
The frequency of different treatments adopted in adjuvant setting according to neoadjuvant treatment type, initial staging and molecular subtypes.
HER-2 positive and Triple Negative patients
Measured: 5 years
The frequency of pathologic complete response (pCR) according to molecular subtypes and neoadjuvant treatment;
HER-2 positive and Triple Negative patients
Measured: 5 years
Descriptive analysis of the correlation between complete radiologic response and pCR according to molecular subtypes and neoadjuvant treatment.
HER-2 positive and Triple Negative patients
Measured: 5 years
Descriptive analysis of the correlation between pCR and DFS according to the different molecular subtypes.
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.
Measured: 5 years
Correlation analysis between pCR and OS according to the different molecular subtypes.
HER-2 positive and Triple Negative patients.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start3 Dec 2022
- Primary completion3 Dec 2025 (estimated)
- Study completion3 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alessandra Fabi, Principal investigator, Fondazione Policlinico Universitario A.Gemelli IRCCS, UOC SenologiaAntonella Palazzo, Principal investigator, Fondazione Policlinico Universitario A.Gemelli IRCCS, UOC Oncologia Medica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06894173
- Sponsor's protocol ID
- 4946
- Acronym
- GIM28-ELMER
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06894173
- Acronym / sponsor ID
- GIM28-ELMER / 4946
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 3 Dec 2022 (actual)
- Primary completion
- 3 Dec 2025 (estimated)
- Study completion
- 3 Dec 2026 (estimated)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alessandra Fabi principal investigator
Fondazione Policlinico Universitario A.Gemelli IRCCS, UOC Senologia
Antonella Palazzo principal investigator
Fondazione Policlinico Universitario A.Gemelli IRCCS, UOC Oncologia Medica
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 29 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessandra Fabi, MD (0630157337, alessandra.fabi@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with HER2-positive and Triple Negative tumour among early breast cancer who underwent neoadjuvant treatment (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.