Innovative "Scoring System" in Breast Cancer Post Neoadiuvant Chemotherapy (BreastNESSy)

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Completed

Conditions

Early Breast Cancer

Treatments

Diagnostic Test: Evaluation with new scoring system

Study type

Observational

Funder types

Other

Identifiers

NCT05213403

4694

Details and patient eligibility

About

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.

Enrollment

255 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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