Breast Cancer Proteomics and Molecular Heterogeneity

• ClinicalTrials.gov Identifier: NCT01840293
• Recruitment Status: Recruiting
• First Posted: April 25, 2013
• Last Update Posted: February 26, 2020
• Sponsor: Cancer Trials Ireland
• Information provided by (Responsible Party): Cancer Trials Ireland

Study Description

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

Condition or disease
Primary Breast Cancer; Recurrent/Metastatic Breast Cancer

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 Design

• Study Type: Observational
• Estimated Enrollment: 1780 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: Breast Cancer Proteomics and Molecular Heterogeneity
• Study Start Date: February 2013
• Estimated Primary Completion Date: December 2029
• Estimated Study Completion Date: December 2029

Groups and Cohorts

Group/Cohort
Primary Breast Cancer
Recurrent/Metastatic Breast Cancer

Outcome Measures

Primary Outcome Measures :

1. Investigation of proteins and their pathways in primary breast cancer [ Time Frame: 10 years ]
   Investigation of proteins and their pathways in primary breast cancer, which are associated with patient outcome.

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

All newly diagnosed breast cancer patients, recurrent and stage IV metastatic breast cancer patients.

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

Contacts and Locations

Locations

Ireland

St. Vincent's University Hospital; Recruiting

Dublin 4, Ireland

Contact: Cancer Trials 01 221 4000

Beaumont Hospital; Recruiting

Dublin, Ireland

Contact: Contact Person 01- 809 3000

Principal Investigator: Arnold Hill, Prof

Principal Investigator: Bryan Hennessy, Prof

Sponsors and Collaborators

Cancer Trials Ireland

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Charmsaz S, Doherty B, Cocchiglia S, Varešlija 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.

Charmsaz S, Hughes É, Bane FT, Tibbitts P, McIlroy M, Byrne C, Cocchiglia S, McBryan J, Hennessy BT, Dwyer RM, Kerin MJ, Hill AD, Young LS. S100β as a serum marker in endocrine resistant breast cancer. BMC Med. 2017 Apr 12;15(1):79. doi: 10.1186/s12916-017-0836-2.

• Responsible Party: Cancer Trials Ireland
• ClinicalTrials.gov Identifier: NCT01840293
• Other Study ID Numbers: ICORG 09-07
• First Posted: April 25, 2013
• Last Update Posted: February 26, 2020
• Last Verified: February 2020

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases