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OpenTrials
Completed

NCT Number: NCT01840306

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms HER2 Negative Breast Cancer HER2 Positive Breast Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Bon Secours Hospital, Cork, Ireland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • Patients who do not fulfil the inclusion criteria mentioned above

Treatment and study plan

Biomarker Analysis

Other

Primary outcomes

  1. Identification of Extra Cellular RNAs/proteins in sera from cancer patients

    Time frame: 7 years

    Identification of EC RNAs/proteins in sera from cancer patients, which correlate with their response to treatment

Sponsors and collaborators

Lead sponsor

Cancer Trials Ireland

Network

Registry information

Important dates

Study start
2012
Primary completion
2023
Study completion
2023
First posted
Apr 25, 2013
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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