Breast Cancer Proteomics and Molecular Heterogeneity

Cancer Trials Ireland

Status: Enrolling

Conditions: Recurrent/Metastatic Breast Cancer; Primary Breast Cancer

Study type: Observational

Funder types: NETWORK

Identifiers

NCT01840293

ICORG 09-07

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,780 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

1,780 participants in 2 patient groups

Primary Breast Cancer

Recurrent/Metastatic Breast Cancer