Innovative "Scoring System" in Breast Cancer Post Neoadiuvant Chemotherapy

Completed

• Conditions: Early Breast Cancer
• Interventions: Diagnostic Test: Evaluation with new scoring system

• Registration Number: NCT05213403
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2021-03-31
• Study Completion: 2021-12-31
• Status Verified: 2022-01
• Study First Submitted: 2022-01-26
• Study First Submitted QC: 2022-01-26
• Last Update Submitted: 2022-01-26
• Study First Posted: 2022-01-28
• Last Update Posted: 2022-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 255

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient G1	Evaluation with new scoring system	Correlation between surgery and scoring system
Patients G2	Evaluation with new scoring system	Incongruence between surgery and scoring system

Primary Outcome Measures

Name	Time	Method
Development of a new scoring system	2016-2021	Definition of a scoring system aimed to perform the radicality desease and aesthetic outcomes in line with expectance of patients

Secondary Outcome Measures

Name	Time	Method
Evaluation of outcome disease	2016-2021	Capacity of the new score system to avoid loco-regional disease; Distant disease and Overall survival.