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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:
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The frequency of different treatments used in neoadjuvant setting according to initial staging and molecular subtypes; | 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; |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alessandra Fabi, MD | Contact | 0630157337 | alessandra.fabi@policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS - Centro di Riferimento Oncologico (C.R.O.) di Aviano | Active, not recruiting | Aviano | PN | 33081 | Italy | |
It is not yet known if there will be a plan to make IPD available.
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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; | 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; | 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. | HER-2 positive and Triple Negative patients | 5 years |
| The frequency of pathologic complete response (pCR) according to molecular subtypes and neoadjuvant treatment; | 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. | HER-2 positive and Triple Negative patients | 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. | 5 years |
| Correlation analysis between pCR and OS according to the different molecular subtypes. | HER-2 positive and Triple Negative patients. | 5 years |
| AOU Ospedali Riuniti Torrette di Ancona |
| Not yet recruiting |
| Ancona |
| 60126 |
| Italy |
|
| A.O.R.N. "San Giuseppe Moscati" | Recruiting | Avellino | 83100 | Italy |
|
| Presidio di Brindisi Di Summa - Perrino | Not yet recruiting | Brindisi | 72100 | Italy |
|
| Humanitas Istituto Clinico Catanese | Not yet recruiting | Catania | 95045 | Italy |
|
| Azienda Ospedaliera Universitaria "San Martino" - Istituto Nazionale per la Ricerca sul Cancro | Not yet recruiting | Genova | 16132 | Italy |
|
| ASST - Azienda Ospedaliera Carlo Poma di Mantova | Recruiting | Mantua | 46100 | Italy |
|
| Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l. | Recruiting | Meldola | 47014 | Italy |
|
| Istituto Europeo di Oncologia | Not yet recruiting | Milan | 20141 | Italy |
|
| ASST - Ospedale Sacco | Not yet recruiting | Milan | 20157 | Italy |
|
| Azienda Ospedaliera Universitaria - P.O. di Modena | Not yet recruiting | Modena | 41124 | Italy |
|
| Azienda Ospedaliera "A. Cardarelli" | Active, not recruiting | Naples | 80131 | Italy |
| Istituto Nazionale Tumori di Napoli - IRCCS Istituto Pascale | Recruiting | Naples | 80131 | Italy |
|
| Universita' degli Studi di Napoli Federico II | Not yet recruiting | Naples | 80131 | Italy |
|
| Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara | Not yet recruiting | Novara | 28100 | Italy |
|
| Azienda Ospedaliero-Universitaria di Parma | Not yet recruiting | Parma | 43126 | Italy |
|
| Azienda Ospedaliera Regionale San Carlo | Not yet recruiting | Potenza | 85100 | Italy |
|
| Nuovo Ospedale di Prato - S. Stefano | Recruiting | Prato | 59100 | Italy |
|
| Azienda Ospedaliera San Camillo Forlanini | Active, not recruiting | Roma | 00152 | Italy |
| AOU Policlinico Umberto I | Not yet recruiting | Roma | 00155 | Italy |
|
| Ospedale Sandro Pertini - ASL Roma 2 | Not yet recruiting | Roma | 00155 | Italy |
|
| Fondazione Policlinico A. Gemelli, IRCCS | Recruiting | Roma | 00168 | Italy |
|
| Fondazione Policlinico Universitario A. Gemelli IRCCS | Recruiting | Roma | 00168 | Italy |
|
| Fondazione Policlinico Universitario A. Gemelli | Recruiting | Roma | 00168 | Italy |
|
| Arcispedale di Santo Spirito in Sassia - Nuovo Regina Margherita | Not yet recruiting | Roma | 00193 | Italy |
|
| Azienda Socio Sanitaria Territoriale ( ASST ) della Valtellina e Alto Lario Presidio di Sondalo | Not yet recruiting | Sondalo | 23035 | Italy |
|
| A.O.U. Città della salute e della scienza - Presidio Molinette | Not yet recruiting | Torino | 10126 | Italy |
|
| APSS - Ospedale Santa Chiara di Trento | Not yet recruiting | Trento | 38122 | Italy |
|
| Ospedale di Belcolle - Viterbo | Not yet recruiting | Viterbo | 01100 | Italy |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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