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Exosomal and Free Extracellular RNAs and Proteins as Predictive Biomarkers for HER2 Therapies in Breast Cancer

NCT01840306 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 330

Last updated 2025-07-08

No results posted yet for this study

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.

Conditions

  • Breast Cancer
  • HER2 Positive Breast Cancer
  • HER2 Negative Breast Cancer

Interventions

OTHER

Biomarker Analysis

Sponsors & Collaborators

  • Cancer Trials Ireland

    lead NETWORK

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-12
Primary Completion
2023-05-24
Completion
2023-05-24

Countries

  • Ireland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01840306 on ClinicalTrials.gov