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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01840306
• Other study ID #: ICORG 10-15
• Status: Completed
• Start date: October 12, 2012
• Est. completion date: May 24, 2023

Study information

• Verified date: October 2023
• Source: Cancer Trials Ireland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: May 24, 2023
• Est. primary completion date: May 24, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Biomarker Analysis

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Trials Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of Extra Cellular RNAs/proteins in sera from cancer patients	Identification of EC RNAs/proteins in sera from cancer patients, which correlate with their response to treatment	7 years