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OpenTrials
Completed

NCT Number: NCT05213403

Innovative "Scoring System" in Breast Cancer Post Neoadiuvant Chemotherapy

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.

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Key information

Conditions

Early Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evaluation with new scoring system

Diagnostic Test

Evaluate whether patients who have received surgery in line with the developed "scoring system" have a better aesthetic and oncological outcomes

Primary outcomes

  1. Development of a new scoring system

    Time frame: 2016-2021

    Definition of a scoring system aimed to perform the radicality desease and aesthetic outcomes in line with expectance of patients

Secondary outcomes

  1. Evaluation of outcome disease

    Time frame: 2016-2021

    Capacity of the new score system to avoid loco-regional disease; Distant disease and Overall survival.

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: BreastNESSy

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Jan 28, 2022
Registry last updated
Jan 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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