Innovative Scoring System in Breast Cancer Post Neoadiuvant Chemotherapy

Study Overview
=================
Brief Summary
-----------------
Our aim is to create a Scoring System (SS) able of guaranteeing radical oncology by completely removing cancer and aesthetic outcomes in line with the needs or expectations of the patients that helps surgeons to decide the type of surgery in patients undergoing NACT. Secondary outcome is to assess the ability of the score to avoid neoplastic relapses by evaluating: Loco-regional disease free-survival (LR-DFS): months between start of NACT and date of a neoplastic recurrence in residual mammary gland, in ipsilateral chest wall or in ipsilateral axilla. Distant disease-free survival (DDFS): months between start of NACT and date of onset of visceral or skeletal metastases. Overall survival (OS): months from the start of NACT to death or last follow-up.

Official Title
-----------------
Innovative Scoring System in Breast Cancer: a Valid Surgical Choice After Neoadjuvant Chemotherapy

Conditions
-----------------
Early Breast Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: Evaluation with new scoring system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing neoadjuvant chemotherapy Surgery: Breast conservative surgery; Oncoplastic surgery type II; Conservative mastactomy (nipple sparing - NSM or skin sparing - SSM) Exclusion Criteria: lack of initial staging or restaging; previous or synchronous history of systemic malignant neoplasms. history of homo-or contralateral breast cancer. initial evidence of metastatic pathology or development of metastases during noeadjuvant chemotherapy (Stage IV) indication to modified radical mastectomy (MRM) without delayed reconstruction

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient G1<br>Correlation between surgery and scoring system | Diagnostic Test: Evaluation with new scoring system<br>* Evaluate whether patients who have received surgery in line with the developed scoring system have a better aesthetic and oncological outcomes<br>|
| Patients G2<br>Incongruence between surgery and scoring system | Diagnostic Test: Evaluation with new scoring system<br>* Evaluate whether patients who have received surgery in line with the developed scoring system have a better aesthetic and oncological outcomes<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of a new scoring system | Definition of a scoring system aimed to perform the radicality desease and aesthetic outcomes in line with expectance of patients | 2016-2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of outcome disease | Capacity of the new score system to avoid loco-regional disease; Distant disease and Overall survival. | 2016-2021 |