Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06441240
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-04-29
Brief Title:
Evaluation of Recurrence Risk Factors in Locally Advanced Breast Cancer Patients Underwent Neoadjuvant Chemotherapy
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Evaluation of Recurrence Risk Factors in Locally Advanced Breast Cancer Patients Underwent Neoadjuvant Chemotherapy The NEORISK Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NEORISK
Brief Summary:
INTRODUCTION Breast cancer BC is the leading cause of cancer-related death in women Since the early 1980s the implementation of screening programs has reduced the number of patients diagnosed with locally advanced breast cancer Currently the treatment for these patients involves initial neoadjuvant chemotherapy NACT followed by surgical treatment In recent years NACT has also been used for highly chemoresponsive tumors such as triple-negative TN and HER2-positive HER2 breast cancer
The widespread use of NACT has led to additional benefits including downstaging of breast and axillary neoplasms resulting in reduced morbidity improved cosmetic outcomes due to increased use of conservative interventions and personalized adjuvant chemotherapy treatment Several studies have shown that response to chemotherapy predicts better systemic outcomes Complete pathological response pCR defined as the absence of invasive neoplastic residue in the surgical specimen has been predictive of better distant outcomes Limited evidence exists regarding other predictive factors for distant outcomes
Given the significant impact of disease recurrence on patient prognosis efforts have been made to understand the factors contributing to recurrence and to predict which patients are more prone to relapse In this context the term Early Disease Recurrence EDR has been coined to define the occurrence of disease recurrence both locally and distantly within 3 years after completing treatment
In recent years the potential of radiomic analysis in aiding diagnostic and therapeutic decision-making processes in BC has been demonstrated Specifically radiomic features obtained from Magnetic Resonance Imaging MRI images appear capable of predicting tumor receptor status differentiating tumor subtypes and predicting response to NACT
Although the role of radiomics in predicting recurrence has been investigated research is still in its early stages and there are variations in technology and methodology for extracting radiomic features Additionally to date no studies have evaluated the feasibility and reliability of using radiomic models combined with clinical and radiological variables to predict disease recurrence in BC patients undergoing NACT
The widespread use of NACT has led to additional benefits including downstaging of breast and axillary neoplasms resulting in reduced morbidity improved cosmetic outcomes due to increased use of conservative interventions and personalized adjuvant chemotherapy treatment Several studies have shown that response to chemotherapy predicts better systemic outcomes Complete pathological response pCR defined as the absence of invasive neoplastic residue in the surgical specimen has been predictive of better distant outcomes Limited evidence exists regarding other predictive factors for distant outcomes
Given the significant impact of disease recurrence on patient prognosis efforts have been made to understand the factors contributing to recurrence and to predict which patients are more prone to relapse In this context the term Early Disease Recurrence EDR has been coined to define the occurrence of disease recurrence both locally and distantly within 3 years after completing treatment
In recent years the potential of radiomic analysis in aiding diagnostic and therapeutic decision-making processes in BC has been demonstrated Specifically radiomic features obtained from Magnetic Resonance Imaging MRI images appear capable of predicting tumor receptor status differentiating tumor subtypes and predicting response to NACT
Although the role of radiomics in predicting recurrence has been investigated research is still in its early stages and there are variations in technology and methodology for extracting radiomic features Additionally to date no studies have evaluated the feasibility and reliability of using radiomic models combined with clinical and radiological variables to predict disease recurrence in BC patients undergoing NACT
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None