Ignite Creation Date:
2024-05-06 @ 6:42 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05750719
Status:
COMPLETED
Last Update Posted:
2023-03-02
First Post:
2023-02-20
Brief Title:
BRCA and NACT in TNBC Patients
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Impact of BRCA Mutation Status on Outcome and Response to Neoadjuvant Chemotherapy NACT in Triple-negative Breast Cancer TNBC Patients
Status:
COMPLETED
Status Verified Date:
2023-02
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:
Light-Bright
Brief Summary:
The goal of this observational study is to evaluate data from patients with triple-negative breast cancer TNBC treated with neoadjuvant chemotherapy NACT in order to better define the impact of germline BRCA12 gBRCA12 mutation status on outcomes in this patient population
The aims of the study are
To evaluate the rate of pathologic complete response pCR in patients with locally advanced TNBC who performed NACT in relation to the mutational status of gBRCA
To evaluate Evaluate Event Free survival EFS and Overall Survival OS in this patients population
The aims of the study are
To evaluate the rate of pathologic complete response pCR in patients with locally advanced TNBC who performed NACT in relation to the mutational status of gBRCA
To evaluate Evaluate Event Free survival EFS and Overall Survival OS in this patients population
Detailed Description:
Triple-negative breast cancer TNBC is characterized by earlier recurrence and shorter survival compared with other types of breast cancer Moreover approximately 15 to 25 of all TNBC patients harbor germline BRCA gBRCA 12 mutations which confer a more aggressive phenotype However TNBC seems to be particularly sensitive to chemotherapy the so-called triple negative paradox Therefore Neoadjuvant chemotherapy NACT is currently considered the preferred approach for early-stage TNBC BRCA status has also been studied as a predictive biomarker of response to platinum compounds Although several randomized trials investigated the addition of carboplatin to standard NACT in early-stage TNBC the role of BRCA status remains unclear In this retrospective analysis data from 136 consecutive patients with Stage I-III TNBC who received standard NACT with or without the addition of carboplatin will be evaluated in order to define clinical features and outcomes in BRCA 12 mutation carriers and non-carrier controls
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