NCT01840293

Breast Cancer Proteomics and Molecular Heterogeneity

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,780 (estimated)
• Sponsor: Cancer Trials Ireland · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary objective: The primary objective is to define the proteomic and molecular characteristics of primary and recurrent/ metastatic breast tumours with special focus on the expression of S100 protein and the estrogen receptor (ER), progesterone receptor (PR) and epidermal growth factor receptor 2 (HER2) genes Secondary objective: * To expand our understanding of the complex molecular pathways dictating the progression of breast cancer and their response to different treatment regimes. * To relate proteomic findings to survival data * To identify potential serum markers of breast cancer progression

Detailed description

This is a translational study. Patient will undergo standard treatment and tissue and blood samples will be taken at various time points: Tissue: Fresh frozen (FF) and Formalin fixed paraffin embedded tissue (FFPE) will be collected at time of surgery/biopsy of a primary or a recurrent/metastatic tumour tissue. Blood: Two types of study bloods (non-heparinised and Ethylenediaminetetraacetic acid (EDTA)) will be taken pre-neoadjuvant treatment (if applicable), pre- and post-operatively of primary and recurrent/ metastatic breast cancer (if recurrent/metastatic diagnosis and no biopsy/surgery required then study bloods will be taken prior to starting treatment). Additional blood samples will be taken annually at follow-up visits for 5 years from primary cases and for up to 2 years from recurrent/metastatic cases. Non-heparinised blood will be processed to serum. Clinical data will be collected at all times of biological sampling.

Conditions

• Primary Breast Cancer
• Recurrent/Metastatic Breast Cancer

Timeline

• Start date: 2013-02-01
• Primary completion: 2029-12-01
• Completion: 2038-01-01
• First posted: 2013-04-25
• Last updated: 2025-12-19

Locations

6 sites across 1 country: Ireland