Innovative Scoring System in Breast Cancer Post Neoadiuvant Chemotherapy

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05213403

Acronym

BreastNESSy

Enrollment

255

Registered

2022-01-28

Start date

2016-01-01

Completion date

2021-12-31

Last updated

2022-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Breast Cancer

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.

Interventions

DIAGNOSTIC_TESTEvaluation 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

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026