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BRCA and NACT in TNBC Patients

NCT05750719 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 136

Last updated 2023-03-02

No results posted yet for this study

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 BRCA1/2 (gBRCA1/2) 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.

Conditions

  • Triple-Negative Breast Cancer

Interventions

GENETIC

BRCA1/2 genetic testing

All patients will undergo genetic testing for BRCA 1 and BRCA 2 germline mutations, employing next generation sequencing (NGS) techniques.

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-02
Primary Completion
2022-10-01
Completion
2022-10-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05750719 on ClinicalTrials.gov