Exosomal and Free Extracellular RNAs and Proteins as Predictive Biomarkers for HER2 Therapies in Breast Cancer
18 Years
N/A
Female
Breast Cancer, HER2 Positive Breast Cancer, HER2 Negative Breast Cancer
Trial Information
Exosomal and Free Extracellular RNAs and Proteins as Predictive Biomarkers for HER2 Therapies in Breast Cancer
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.
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Identification of Extra Cellular RNAs/proteins in sera from cancer patients
Outcome Description:
Identification of EC RNAs/proteins in sera from cancer patients, which correlate with their response to treatment
Outcome Time Frame:
7 years
Safety Issue:
No
Authority:
Ireland: Health Information and Quality Authority
Study ID:
ICORG 10-15
NCT ID:
NCT01840306
Start Date:
October 2012
Completion Date:
Related Keywords:
- Breast Cancer
- HER2 Positive Breast Cancer
- HER2 Negative Breast Cancer
- Breast Neoplasms
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