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|ClinicalTrials.gov Identifier: NCT01722851|
Recruitment Status : Active, not recruiting
First Posted : November 7, 2012
Last Update Posted : March 24, 2021
|Condition or disease|
|Breast Cancer Newly Diagnosed Breast Cancer Recurrent Breast Cancer|
|Study Type :||Observational|
|Actual Enrollment :||255 participants|
|Official Title:||Novel Breast Cancer Biomarkers and Their Use for Guiding and Monitoring Response to Chemotherapy|
|Study Start Date :||May 2011|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||December 2021|
All newly diagnosed breast cancer patients who are scheduled to undergo neoadjuvant chemotherapy
All breast cancer patients who present with metastatic disease, disease recurrence or progression, who are commencing up-front chemotherapy ± hormonal therapy
All breast cancer patient who present with metastatic disease who are commencing hormonal therapy only.
- Relationship between changes in a patients circulating miRNA expression levels over the course of their systemic therapy, and their response to that treatment. [ Time Frame: Up to week 66-92 ]
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."
- Correlation of systemic miRNA levels with standard biomarkers of response [ Time Frame: Up to week 66-92 ]Standard bio markers of response include serum CEA and Ca15-3 levels
- Relationship between circulating miRNA profiles and patients' intrinsic subtype of breast cancer [ Time Frame: Up to week 66-92 ]
- Relationship between miRNA expression levels and other existing clinicopathological parameters. [ Time Frame: Up to week 66-92 ]Other existing clinicopathological parameters include: ER, PR and HER2 status, stage of disease,histological grade and size of the tumour, and the Nottingham Prognostic Index.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01722851
|Bon Secours Hospital|
|St James's Hospital|
|University Hospital Galway|
|Letterkenny General Hospital|
|Sligo General Hospital|
|Midlands Regional Hospital Tullamore|