Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-25 @ 4:58 PM
Study NCT ID:
NCT05213403
Status:
COMPLETED
Last Update Posted:
2022-01-28
First Post:
2022-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Innovative "Scoring System" in Breast Cancer Post Neoadiuvant Chemotherapy
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Study Overview
Official Title:
Innovative "Scoring System" in Breast Cancer: a Valid Surgical Choice After Neoadjuvant Chemotherapy
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BreastNESSy
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.
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: