Breast Cancer
Conditions
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.
Interventions
None listed
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with HER2-positive and Triple Negative tumour among early breast cancer who underwent neoadjuvant treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The frequency of different treatments used in neoadjuvant setting according to initial staging and molecular subtypes; | 5 years | HER-2 positive and Triple Negative patients subtypes. |
| The frequency of different clinical and pathological tumour characteristics according to initial staging and molecular subtypes; | 5 years | HER-2 positive and Triple Negative patients |
| 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 | HER-2 positive and Triple Negative patients |
| The frequency of different surgical procedures for both, the breast and the axilla, according to radiological response, initial staging and molecular subtypes; | 5 years | HER-2 positive and Triple Negative patients |
| Descriptive analysis of the correlation between complete radiologic response and pCR according to molecular subtypes and neoadjuvant treatment. | 5 years | HER-2 positive and Triple Negative patients |
| The frequency of pathologic complete response (pCR) according to molecular subtypes and neoadjuvant treatment; | 5 years | HER-2 positive and Triple Negative patients |
| Descriptive analysis of the correlation between pCR and DFS according to the different molecular subtypes. | 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. |
| Correlation analysis between pCR and OS according to the different molecular subtypes. | 5 years | HER-2 positive and Triple Negative patients. |
| The frequency of different treatments adopted in adjuvant setting according to neoadjuvant treatment type, initial staging and molecular subtypes. | 5 years | HER-2 positive and Triple Negative patients |
Countries
Italy
Contacts
Primary ContactAlessandra Fabi, MD
Outcome results
None listed