Circulating miRNAs.

NCT01722851 | Completed

• 1 other identifier: ICORG 10-11
• Study Type: observational
• Target: 255
• Locations: 1 country
• Sites: 7

Brief Summary

To identify a panel of circulating miRNA markers which could help identify those breast cancer patients who are most likely to respond well to neoadjuvant and adjuvant chemotherapy, and indeed serve as an overall prognostic factor and stratify patients into risk categories which would further guide their management. Similarly, the investigators aim to identify a panel of circulating miRNA markers which could monitor patient's response to chemotherapy and hormonal therapies. Ideally a suitable panel of markers would show significant changes in expression level in good-responders whilst little or no change would be observed in miRNA expression in non-responders.

Conditions

Breast Cancer; Newly Diagnosed Breast Cancer; Recurrent Breast Cancer

Keywords

Breast Cancer; miRNAs; Newly diagnosed; Recurrent

Outcome Measures

Primary Outcomes (2)

• Relationship between changes in a patients circulating miRNA expression levels over the course of their systemic therapy, and their response to that treatment.

  For cohort 1, a patient's response to treatment will be determined using 3 standard parameters: clinical, radiological and pathological responses. For cohort 2 and 3, a patient's response to treatment will be evaluated using RECIST criteria version 1.1." For cohort 1, a patient's response to treatment will be determined using 3 standard parameters: clinical, radiological and pathological responses. For cohort 2 and 3, a patient's response to treatment will be evaluated using RECIST criteria version 1.1."

  Up to week 66-92

• Correlation of systemic miRNA levels with standard biomarkers of response

  Standard bio markers of response include serum CEA and Ca15-3 levels

  Up to week 66-92

Secondary Outcomes (2)

• Relationship between circulating miRNA profiles and patients' intrinsic subtype of breast cancer

  Up to week 66-92

• Relationship between miRNA expression levels and other existing clinicopathological parameters.

  Up to week 66-92

Study Arms (3)

Cohort 1

All newly diagnosed breast cancer patients who are scheduled to undergo neoadjuvant chemotherapy

Cohort 2

All breast cancer patients who present with metastatic disease, disease recurrence or progression, who are commencing up-front chemotherapy ± hormonal therapy

Cohort 3

All breast cancer patient who present with metastatic disease who are commencing hormonal therapy only.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Investigators aim to study two populations of breast cancer patients: 1. Patients undergoing neoadjuvant chemotherapy for breast cancer at tertiary referral breast cancer centres in Ireland. For GUH only: Additionally,investigators wish to evaluate miRNA expression levels in patients' diagnostic core biopsies. 2. Investigators also wish to study the same panel of miRNAs in patients who present with disease recurrence or disease progression, and who are commenced on systemic therapies (hormonal and/or chemotherapy).

You may qualify if:

• Patient must meet the criteria for either:
• Cohort 1: All patients with a new diagnosis of breast cancer, who are destined to undergo neoadjuvant chemotherapy.
• OR Cohort 2: All breast cancer patients who present with metastatic disease, disease recurrence or progression who will receive up-front chemotherapy ± hormonal therapy.
• OR Cohort 3: All breast cancer patient who present with metastatic disease who are commencing hormonal therapy only.
• Patients must be aged 18 years or over.
• Patients must be able to give written informed consent.

Sponsors & Collaborators

• Cancer Trials Ireland: lead

Study Sites (7)

Bon Secours Hospital

Cork, Ireland

Location

Beaumont Hospital

Dublin, Ireland

Location

St James's Hospital

Dublin, Ireland

Location

University Hospital Galway

Galway, Ireland

Location

Letterkenny General Hospital

Letterkenny, Ireland

Location

Sligo General Hospital

Sligo, Ireland

Location

Midlands Regional Hospital Tullamore

Tullamore, Ireland

Location

Related Publications (2)

• Davey MG, McGuire A, Casey MC, Waldron RM, Paganga M, Holian E, Newell J, Heneghan HM, McDermott AM, Keane MM, Lowery AJ, Miller N, Kerin MJ. Evaluating the Role of Circulating MicroRNAs in Predicting Long-Term Survival Outcomes in Breast Cancer: A Prospective, Multicenter Clinical Trial. J Am Coll Surg. 2023 Feb 1;236(2):317-327. doi: 10.1097/XCS.0000000000000465. Epub 2022 Nov 2.

  PMID: 36648259 DERIVED

• Davey MG, Casey MC, McGuire A, Waldron RM, Paganga M, Holian E, Newell J, Heneghan HM, McDermott AM, Keane MM, Lowery AJ, Miller N, Kerin MJ. Evaluating the Role of Circulating MicroRNAs to Aid Therapeutic Decision Making for Neoadjuvant Chemotherapy in Breast Cancer: A Prospective, Multicenter Clinical Trial. Ann Surg. 2022 Nov 1;276(5):905-912. doi: 10.1097/SLA.0000000000005613. Epub 2022 Jul 25.

  PMID: 35876391 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2012
• First Posted: November 7, 2012
• Study Start: May 1, 2011
• Primary Completion: April 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 8, 2025

Record last verified: 2025-07

Locations

IE (7)