MicroRNA and Relevant Biomarkers of Breast Cancer in Patients Undergoing Neoadjuvant Treatment
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Objective Response
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Objective Response
Time Frame: Every 2 cycles, up to surgery (each cycle is 21 days)
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Cui Yimin
Director of pharmacy, M.D & Ph.D
Peking University First Hospital