Exosomal and Free Extracellular RNAs and Proteins as Predictive Biomarkers for HER2 Therapies in Breast Cancer
1 other identifier
observational
330
1 country
11
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. absence (or relative levels) of identified extracellular (EC) RNAs/proteins and patients' clinicopathological characteristics, including age at diagnosis, time to progression and overall survival, as well as correlations with serum protein biomarkers routinely analysed for these patients. (iii) To compare HER2 positive samples versus HER2 negative samples for the existence of RNAs/proteins identified in (i) and (ii). Secondary Objective: To develop a predictive model for use in the HER2 positive population based on the most accurate and sensitive combination of the identified biomarkers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2012
Longer than P75 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 12, 2012
CompletedFirst Submitted
Initial submission to the registry
April 23, 2013
CompletedFirst Posted
Study publicly available on registry
April 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 24, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 24, 2023
CompletedJuly 8, 2025
July 1, 2025
10.6 years
April 23, 2013
July 4, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Identification of Extra Cellular RNAs/proteins in sera from cancer patients
Identification of EC RNAs/proteins in sera from cancer patients, which correlate with their response to treatment
7 years
Study Arms (2)
Cohort 1: HER2 positive breast cancer
Female patients with newly diagnosed (including metastatic) HER2 positive breast cancer.
Cohort 2: HER2 negative breast cancer
Female patients with newly diagnosed HER2 negative breast cancer
Interventions
Eligibility Criteria
* HER2 positive breast cancer:Female patients with newly diagnosed (including metastatic) HER2 positive breast cancer. * HER2 negative breast cancer:Female patients with newly diagnosed HER2 negative breast cancer.
You may qualify if:
- Patient with a newly diagnosed (including metastatic) HER2 positive breast cancer, who is to commence HER2 targeted treatment.
- \- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Bon Secours Hospital
Cork, Ireland
Cork University Hospital
Cork, Ireland
Letterkenny General Hospital
Donegal, Ireland
Our Lady of Lourdes Hospital
Drogheda, Ireland
Beacon Hospital
Dublin, Ireland
Beaumont Hospital
Dublin, Ireland
St James's Hospital
Dublin, Ireland
St Vincent's University Hospital
Dublin, Ireland
The Adelaide & Meath Hospital, Dublin Incorporating the National Children's Hospital
Dublin, Ireland
Sligo General Hospital
Sligo, Ireland
University Hospital Waterford
Waterford, Ireland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2013
First Posted
April 25, 2013
Study Start
October 12, 2012
Primary Completion
May 24, 2023
Study Completion
May 24, 2023
Last Updated
July 8, 2025
Record last verified: 2025-07