Breast Cancer Proteomics and Molecular Heterogeneity

Primary Breast Cancer Clinical Trial

Official title:

Breast Cancer Proteomics and Molecular Heterogeneity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01840293
• Other study ID #: ICORG 09-07
• Status: Recruiting
• Start date: February 2013
• Est. completion date: January 2038

Study information

• Verified date: April 2023
• Source: Cancer Trials Ireland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1780
• Est. completion date: January 2038
• Est. primary completion date: December 2029
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Primary Breast Cancer
• Recurrent/Metastatic Breast Cancer

Locations

Country	Name	City	State
Ireland	Beaumont Hospital	Dublin
Ireland	St. Vincent's University Hospital	Dublin 4

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Trials Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigation of proteins and their pathways in primary breast cancer	Investigation of proteins and their pathways in primary breast cancer, which are associated with patient outcome.	10 years
Secondary	Comparison of the molecular profile between primary and recurrent/metastatic lesions in breast cancer		10 years
Secondary	Identification of novel molecular mechanisms of breast cancer recurrence	Identification of novel molecular mechanisms of breast cancer recurrence, therapy resistance and/or metastasis	10 years
Secondary	Determination of novel potential molecular targets	Determination of novel potential molecular targets that can be used to develop future prevention and treatment advances in patients with breast cancer	10 years