Integrated Testing Strategy for Simultaneous Detection of ESR-1 and GBRCA Mutations Via Liquid Biopsy in HR+/HER2- Metastatic Breast Cancer (mBC) Patients,

Last updated: December 31, 2024
Sponsor: European Institute of Oncology
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT06762483
L2-268
  • Ages > 18
  • Female

Study Summary

Development and validation of an integrated testing strategy for simultaneous detection of ESR-1 and gBRCA mutations via liquid biopsy in HR+/HER2- metastatic breast cancer (mBC) patients, and the creation of a digital gene library to support an evidence-based diagnostic algorithm

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants must have a confirmed diagnosis of estrogen receptor-positive (ER+)and/or progesterone receptor-positive (PgR+) breast cancer through histologicaland/or cytological examination by the local laboratory Participants must exhibitHER2-negative breast cancer
  1. or 2+). If IHC is 2+, a negative in situ hybridization (Fluorescent in situhybridization (FISH), Chromogenic in situ hybridization (CISH), orSilver-enhanced in situ hybridization (SISH)) test is required by locallaboratory testing.
  • Participants should be in an advanced or metastatic setting including boththose prior to the initiation of treatment for metastatic disease andthose who experienced progression following treatment withcyclin-dependent kinases (CDK)4/6 inhibitors. However, the primary tumorshould be treated according to the standard of care.
  • Written informed consent must be signed and dated by the patient and theinvestigator prior to inclusion.

Exclusion

Exclusion Criteria:

  • Unable to provide written informed consent

Study Design

Total Participants: 80
Study Start date:
December 20, 2024
Estimated Completion Date:
December 31, 2030

Study Description

Breast cancer is the most prevalent type of tumor and the primary cause of cancer-related deaths among women globally (1). Approximately two-thirds of these tumors express hormone receptors (HR) and lack HER2 overexpression and/or amplification (2). Throughout treatment, resistance frequently develops, with underlying mechanisms that remain largely undefined (3).

Connect with a study center

  • European Institute of oncology

    Milan, 20141
    Italy

    Active - Recruiting

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