Integrated Testing Strategy for Simultaneous Detection of ESR-1 and GBRCA Mutations Via Liquid Biopsy in HR+/HER2- Metastatic Breast Cancer (mBC) Patients,
NCT ID: NCT06762483
Last Updated: 2025-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
80 participants
OBSERVATIONAL
2024-12-20
2030-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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HR+/HER2- metastatic breast cancer (mBC) patients
breast
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
1. or 2+). If IHC is 2+, a negative in situ hybridization (Fluorescent in situ hybridization (FISH), Chromogenic in situ hybridization (CISH), or Silver-enhanced in situ hybridization (SISH)) test is required by local laboratory testing.
* Participants should be in an advanced or metastatic setting including both those prior to the initiation of treatment for metastatic disease and those who experienced progression following treatment with cyclin-dependent kinases (CDK)4/6 inhibitors. However, the primary tumor should be treated according to the standard of care.
* Written informed consent must be signed and dated by the patient and the investigator prior to inclusion.
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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European Institute of Oncology
OTHER
Responsible Party
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Locations
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European Institute of oncology
Milan, Italy, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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L2-268
Identifier Type: -
Identifier Source: org_study_id
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