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

Cancer Trials Ireland

Status: Completed

Conditions: Breast Cancer; HER2 Positive Breast Cancer; HER2 Negative Breast Cancer

Treatments: Other: Biomarker Analysis

Study type: Observational

Funder types: NETWORK

Identifiers

NCT01840306

ICORG 10-15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 330 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

330 participants in 2 patient groups

Cohort 1: HER2 positive breast cancer

Description:

Female patients with newly diagnosed (including metastatic) HER2 positive breast cancer.

Treatment:

Other: Biomarker Analysis

Cohort 2: HER2 negative breast cancer

Description:

Female patients with newly diagnosed HER2 negative breast cancer

Treatment:

Other: Biomarker Analysis