Clinical trial NCT01840293: Breast Cancer Proteomics and Molecular Heterogeneity
Official title: Breast Cancer Proteomics and Molecular Heterogeneity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Breast Cancer
Recurrent/Metastatic Breast Cancer
Lead sponsor: Cancer Trials Ireland
Sponsor class: NETWORK
First posted: 2013-04-25
Enrollment: 1780
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All newly diagnosed breast cancer patients, recurrent and stage IV metastatic breast cancer patients.

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.

Eligibility 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

Primary outcomes:
measure: Investigation of proteins and their pathways in primary breast cancer
timeFrame: 10 years
Secondary outcomes:
measure: Comparison of the molecular profile between primary and recurrent/metastatic lesions in breast cancer
timeFrame: 10 years
measure: Identification of novel molecular mechanisms of breast cancer recurrence
timeFrame: 10 years
measure: Determination of novel potential molecular targets
timeFrame: 10 years
Other outcomes:
Locations:
city: Dublin 4
country: Ireland
facility: St. Vincent's University Hospital
city: Dublin
country: Ireland
facility: Beaumont Hospital
Study officials:
References:
citation: Charmsaz S, Doherty B, Cocchiglia S, Vareslija D, Marino A, Cosgrove N, Marques R, Priedigkeit N, Purcell S, Bane F, Bolger J, Byrne C, O'Halloran PJ, Brett F, Sheehan K, Brennan K, Hopkins AM, Keelan S, Jagust P, Madden S, Martinelli C, Battaglini M, Oesterreich S, Lee AV, Ciofani G, Hill ADK, Young LS. ADAM22/LGI1 complex as a new actionable target for breast cancer brain metastasis. BMC Med. 2020 Nov 19;18(1):349. doi: 10.1186/s12916-020-01806-4.
citation: Charmsaz S, Hughes E, Bane FT, Tibbitts P, McIlroy M, Byrne C, Cocchiglia S, McBryan J, Hennessy BT, Dwyer RM, Kerin MJ, Hill AD, Young LS. S100beta as a serum marker in endocrine resistant breast cancer. BMC Med. 2017 Apr 12;15(1):79. doi: 10.1186/s12916-017-0836-2.