Status:
COMPLETED
Exosomal and Free Extracellular RNAs and Proteins as Predictive Biomarkers for HER2 Therapies in Breast Cancer
Lead Sponsor:
Cancer Trials Ireland
Conditions:
Breast Cancer
HER2 Positive Breast Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
Primary Objective: (i) To identify panels of RNAs and proteins predictive of response to HER2 targeted agents, considering clinical responses. (ii) To investigate associations between presence vs. ab...
Detailed Description
This is a translational pilot study, involving two patient cohorts, designed to identify predictive biomarkers for HER2 targeted therapy, which will be validated in a larger future study. Cohort 1: 3...
Eligibility Criteria
Inclusion
- Patient with a newly diagnosed (including metastatic) HER2 positive breast cancer, who is to commence HER2 targeted treatment.
- OR
- \- Patient with a newly diagnosed HER2 negative breast cancer, who is to commence any type of treatment.
- Patient must be female and aged 18 years or over.
- Patient must provide written informed consent.
Exclusion
- 1\. Patients who do not fulfil the inclusion criteria mentioned above
Key Trial Info
Start Date :
October 12 2012
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 24 2023
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT01840306
Start Date
October 12 2012
End Date
May 24 2023
Last Update
July 8 2025
Active Locations (11)
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1
Bon Secours Hospital
Cork, Ireland
2
Cork University Hospital
Cork, Ireland
3
Letterkenny General Hospital
Donegal, Ireland
4
Our Lady of Lourdes Hospital
Drogheda, Ireland