Innovative "Scoring System" in Breast Cancer Post Neoadiuvant Chemotherapy

Early Breast Cancer Clinical Trial

— BreastNESSy  

Official title:

Innovative "Scoring System" in Breast Cancer: a Valid Surgical Choice After Neoadjuvant Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05213403
• Other study ID #: 4694
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2022
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: December 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Early Breast Cancer

Intervention

Diagnostic Test:
• Evaluation with new scoring system
Evaluate whether patients who have received surgery in line with the developed "scoring system" have a better aesthetic and oncological outcomes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of outcome disease	Capacity of the new score system to avoid loco-regional disease; Distant disease and Overall survival.	2016-2021