miRNA and Relevant Biomarkers of BC Patients Undergoing Neoadjuvant Treatment

Study Overview
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Brief Summary
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MicroRNA (miRNA) is a type of endogenous non-coding RNA. They are responsible for post-transcriptional regulation and participate in many vital biological processes. Expression profiling has shown that miRNAs can distinguish between normal breast and tumor tissues. In recent years, circulating miRNAs have become promising biomarkers based on their stability and their non-invasive testing and feasibility in clinical practices.

Detailed Description
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Current reports showed that serum microRNA expression could be used as an early marker for determining the breast cancer risk. The concentrations of some circulating microRNAs in human breast cancer have been correlated with tumor development and progression. Aberrant miRNA expression may be involved in drug resistance to various chemotherapeutic agents in breast cancer. Therefore, we hope to investigate the value of miRNAs in predicting the effect in breast cancer neoadjuvant treatment.

Official Title
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MicroRNA and Relevant Biomarkers of Breast Cancer in Patients Undergoing Neoadjuvant Treatment

Conditions
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Breast Cancer

Intervention / Treatment
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* Genetic: microRNA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Early breast cancer patients; Stage II-III disease; sign informed consent form; receive neoadjuvant treatment; Age between 18-75. Exclusion Criteria: Women during pregnancy; Metastasis patients or stage IV breast cancer patients; Male breast cancer patients; Inflammatory breast cancer patients; Patients with neoadjuvant endocrine treatment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sensitive<br>Sensitive group was defined ad complete response (CR) and/or partial response (PR). Blood samples for microRNA were collected before neoadjuvant chemotherapy, evaluation of clinical disease response and surgery. | Genetic: microRNA<br>* The level of microRNA in plasma will be detected by TaqMan in screening phase and by quantitative Real-time PCR (qRT-PCR) in validation phase.<br>|
| Resistant<br>Resistant group was defined ad progression disease (PD) and/or stable disease (SD). Blood samples for microRNA were collected before neoadjuvant chemotherapy, evaluation of clinical disease response and surgery. | Genetic: microRNA<br>* The level of microRNA in plasma will be detected by TaqMan in screening phase and by quantitative Real-time PCR (qRT-PCR) in validation phase.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response | Clinical disease response was evaluated for every two cycles of chemotherapy till surgery with RECIST criteria (RECIST 1.1). Resistant group was defined ad progression disease (PD) and/or stable disease (SD).Evaluation in breast lesions by MRI or mammography. The same imaging methods were used throughout treatment for a given patient. Blood samples for microRNA were collected before neoadjuvant chemotherapy, evaluation of clinical disease response and surgery. Clinical disease response was evaluated for every two cycles of chemotherapy till surgery with RECIST criteria (RECIST 1.1). Evaluation in breast lesions by MRI or mammography. The same imaging methods were used throughout treatment for a given patient. | Every 2 cycles, up to surgery (each cycle is 21 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, biomarker, neoadjuvant treatment, microRNA, response