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

January 26, 2022 updated by: FABI ALESSANDRA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

255

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing neoadjuvant chemotherapy subsequently subjected to conservative surgery (Quadrantectomy/lumpectomy), Oncoplastic surgery second level or conservative mastectomy with breast reconstruction

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient G1
Correlation between surgery and scoring system
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
Patients G2
Incongruence between surgery and scoring system
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2016-2021

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Gianluca Franceschini, Prof., IRCCS Policlinico Agostino Gemelli - Roma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2016

Primary Completion (ACTUAL)

March 31, 2021

Study Completion (ACTUAL)

December 31, 2021

Study Registration Dates

First Submitted

January 26, 2022

First Submitted That Met QC Criteria

January 26, 2022

First Posted (ACTUAL)

January 28, 2022

Study Record Updates

Last Update Posted (ACTUAL)

January 28, 2022

Last Update Submitted That Met QC Criteria

January 26, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4694

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Early Breast Cancer

Clinical Trials on Evaluation with new scoring system

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe