Breast Cancer Proteomics and Molecular Heterogeneity

Recruiting

• Conditions: Recurrent/Metastatic Breast Cancer; Primary Breast Cancer

• Registration Number: NCT01840293
• Lead Sponsor: Cancer Trials Ireland

Brief 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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-04-23
• Study First Submitted QC: 2013-04-23
• Study First Posted: 2013-04-25
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-04
• Last Update Posted: 2023-04-06
• Primary Completion: 2029-12
• Study Completion: 2038-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1780

Inclusion Criteria

1. Patients diagnosed with primary breast cancer attending hospital for the resection of their tumour tissue

   Or

   -Patients with suspected or confirmed recurrent or metastatic breast cancer (Patient has a history of a biopsy- or surgically- (i.e. pathologically) confirmed primary breast cancer) attending hospital for the resection/biopsy and/or treatment of tumour tissue

   Or

   -Patient with suspected (but not necessarily biopsy confirmed) newly diagnosed stage 4 breast cancer attending hospital for the resection/biopsy and/or treatment of their tumour tissue

2. Patients receiving neoadjuvant treatment are also eligible (if applicable)

3. Patients have to be ≥ 18 years of age

4. Patients must be able to give informed consent

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Investigation of proteins and their pathways in primary breast cancer	10 years	Investigation of proteins and their pathways in primary breast cancer, which are associated with patient outcome.

Secondary Outcome Measures

Name	Time	Method
Identification of novel molecular mechanisms of breast cancer recurrence	10 years	Identification of novel molecular mechanisms of breast cancer recurrence, therapy resistance and/or metastasis
Comparison of the molecular profile between primary and recurrent/metastatic lesions in breast cancer	10 years
Determination of novel potential molecular targets	10 years	Determination of novel potential molecular targets that can be used to develop future prevention and treatment advances in patients with breast cancer

Trial Locations

Locations (2)

St. Vincent's University Hospital; 🇮🇪 Dublin 4, Ireland

Beaumont Hospital; 🇮🇪 Dublin, Ireland