Recruitment

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