Ignite Creation Date:
2025-12-26 @ 3:58 PM
Ignite Modification Date:
2026-03-02 @ 4:00 PM
Study NCT ID:
NCT01840306
Status:
COMPLETED
Last Update Posted:
2025-07-08
First Post:
2013-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exosomal and Free Extracellular RNAs and Proteins as Predictive Biomarkers for HER2 Therapies in Breast Cancer
Sponsor:
Cancer Trials Ireland
Organization:
Study Overview
Official Title:
Exosomal and Free Extracellular RNAs and Proteins as Predictive Biomarkers for HER2 Therapies in Breast Cancer
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
(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.
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: 300 newly diagnosed (including metastatic) HER2 positive breast cancer patients. Cohort 2: 30 newly diagnosed HER2 negative breast cancer patients.
Blood specimens will be taken:
* before starting treatment (cohort 1 and 2)
* after receiving chemotherapy and before starting HER2 targeted treatment (if applicable) (cohort 1)
* within one month following 1st treatment of HER2 targeted treatment (cohort 1)
* approximately every 3 months (coinciding with formal disease assessment) while on HER2 targeted treatment for a maximum of 5 years (cohort 1)
Blood will be processed to serum, which will be analysed for RNA and protein biomarkers.
Cohort 1: 300 newly diagnosed (including metastatic) HER2 positive breast cancer patients. Cohort 2: 30 newly diagnosed HER2 negative breast cancer patients.
Blood specimens will be taken:
* before starting treatment (cohort 1 and 2)
* after receiving chemotherapy and before starting HER2 targeted treatment (if applicable) (cohort 1)
* within one month following 1st treatment of HER2 targeted treatment (cohort 1)
* approximately every 3 months (coinciding with formal disease assessment) while on HER2 targeted treatment for a maximum of 5 years (cohort 1)
Blood will be processed to serum, which will be analysed for RNA and protein biomarkers.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: