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

October 20, 2023 updated by: Cancer Trials Ireland

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

330

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Cork, Ireland
        • Bon Secours Hospital
      • Cork, Ireland
        • Cork University Hospital
      • Donegal, Ireland
        • Letterkenny General Hospital
      • Drogheda, Ireland
        • Our Lady of Lourdes Hospital
      • Dublin, Ireland
        • Beaumont Hospital
      • Dublin, Ireland
        • St James's Hospital
      • Dublin, Ireland
        • St Vincent's University Hospital
      • Dublin, Ireland
        • Beacon Hospital
      • Dublin, Ireland
        • The Adelaide & Meath Hospital, Dublin Incorporating the National Children's Hospital
      • Sligo, Ireland
        • Sligo General Hospital
      • Waterford, Ireland
        • University Hospital Waterford

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

  • 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.

Description

Inclusion Criteria:

  1. 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.

  2. Patient must be female and aged 18 years or over.
  3. Patient must provide written informed consent.

Exclusion Criteria:

1. Patients who do not fulfil the inclusion criteria mentioned above

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1: HER2 positive breast cancer
Female patients with newly diagnosed (including metastatic) HER2 positive breast cancer.
Other: Biomarker Analysis
Cohort 2: HER2 negative breast cancer
Female patients with newly diagnosed HER2 negative breast cancer
Other: Biomarker Analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Trials Ireland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2012

Primary Completion (Actual)

May 24, 2023

Study Completion (Actual)

May 24, 2023

Study Registration Dates

First Submitted

April 23, 2013

First Submitted That Met QC Criteria

April 23, 2013

First Posted (Estimated)

April 25, 2013

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 20, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICORG 10-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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