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

Completed

• Conditions: HER2 Negative Breast Cancer; Breast Cancer; HER2 Positive Breast Cancer
• Interventions: Other: Biomarker Analysis

• Registration Number: NCT01840306
• Lead Sponsor: Cancer Trials Ireland

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.

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 Timeline

• Study Start: 2012-10-12
• Study First Submitted: 2013-04-23
• Study First Submitted QC: 2013-04-23
• Study First Posted: 2013-04-25
• Primary Completion: 2023-05-24
• Study Completion: 2023-05-24
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-20
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 330

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Identification of Extra Cellular RNAs/proteins in sera from cancer patients	7 years	Identification of EC RNAs/proteins in sera from cancer patients, which correlate with their response to treatment

Trial Locations

Locations (11)

Bon Secours Hospital; 🇮🇪 Cork, Ireland

Cork University Hospital; 🇮🇪 Cork, Ireland

Letterkenny General Hospital; 🇮🇪 Donegal, Ireland

Beacon Hospital; 🇮🇪 Dublin, Ireland

Beaumont Hospital; 🇮🇪 Dublin, Ireland

Our Lady of Lourdes Hospital; 🇮🇪 Drogheda, Ireland

University Hospital Waterford; 🇮🇪 Waterford, Ireland

St Vincent's University Hospital; 🇮🇪 Dublin, Ireland

Sligo General Hospital; 🇮🇪 Sligo, Ireland

St James's Hospital; 🇮🇪 Dublin, Ireland

The Adelaide & Meath Hospital, Dublin Incorporating the National Children's Hospital; 🇮🇪 Dublin, Ireland