Exosomal and Free Extracellular RNAs and Proteins as Predictive Biomarkers for HER2 Therapies in Breast Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Breast Cancer
- HER2 Negative Breast Cancer
- HER2 Positive Breast Cancer
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
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 di...
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.
Tracking Information
- NCT #
- NCT01840306
- Collaborators
- Not Provided
- Investigators
- Not Provided